[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"chronic-lymphocytic-leukemia\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:chronic-lymphocytic-leukemia":25},{"pageToken":4,"total":5,"offset":6,"count":7,"results":8},null,117,0,25,[9,46,73,155,178,208,229,257,274,298,318,343,362,407,430,453,476,509,530,554,583,608,617,637,662],{"id":10,"slug":11,"hasResults":12,"nctId":13,"briefTitle":14,"officialTitle":15,"acronym":16,"eligibilityCriteria":17,"healthyVolunteers":12,"sex":18,"minAge":4,"maxAge":4,"enrollmentInfo":19,"targetDuration":4,"studyType":22,"phases":4,"briefSummary":23,"conditions":24,"keywords":26,"overallStatus":33,"whyStopped":4,"lastUpdateSubmitDate":34,"lastUpdatePostDateStruct":35,"startDateStruct":38,"completionDateStruct":40,"leadSponsor":42,"locationsCount":45},"100054280","aqualisqol-of-cll-patients-treated-with-acalabrutinib-in-france-retrospective-study-based-on-data-from-platon-database-100054280",false,"NCT06548152","AQUALIS:QoL of CLL Patients Treated With Acalabrutinib in France, Retrospective Study Based on Data From PLATON Database","AQUALIS: Quality of Life of Patients With Chronic Lymphocytic Leukemia Treated With Acalabrutinib in France: a Retrospective Observational Study Based on Data Extracted From the PLATON Database","AQUALIS","Inclusion criteria:\n\nThe following patients will be eligible for inclusion in the AQUALIS study :\n\n* Patient enrolled in the PLATON database\n* Patient ≥18 years old\n* Treatment naïve CLL patient treated with acalabrutinib in a real life setting. Treatment pattern is Acala mono or Acala + Obinutuzumab\n* Patient who do not object to his health data collected in PLATON study being re-use for analysis\u002Fresearch purpose\n* Patients who started Acala but discontinued before 12 months are also included.\n\nExclusion criteria:\n\n* Pregnant women\n* Patients under protection of justice\n* Patients over the age of 18 and unable to express their non-opposition\n* Patients with prior CLL treatments","ALL",{"count":20,"type":21},120,"ESTIMATED","OBSERVATIONAL","QoL is often not assessed in real-world studies; hence, there is limited understanding about the real-world QoL of patients diagnosed with CLL. Besides, studies evaluating QoL have largely focused on comparing treated and untreated populations. In particular, QoL of patients treated with acalabrutinib has not been evaluated in a real-life setting.\n\nThe aim of this study is to describe the QoL of CLL patients treated with acalabrutinib between the treatment initiation and twelve months after, in a real-life setting.",[25],"Chronic Lymphocytic Leukemia",[27,28,29,30,31,32],"Chronic Lymphocytic Leukemia (LLC)","Quality of life","Acalabrutinib","France","Retrospective observational study","PLATON database","RECRUITING","2026-07-10",{"date":36,"type":37},"2026-07-13","ACTUAL",{"date":39,"type":37},"2025-04-28",{"date":41,"type":21},"2026-12-31",{"name":43,"class":44},"AstraZeneca","INDUSTRY",1,{"id":47,"slug":48,"hasResults":12,"nctId":49,"briefTitle":50,"officialTitle":51,"acronym":4,"eligibilityCriteria":52,"healthyVolunteers":12,"sex":18,"minAge":53,"maxAge":4,"enrollmentInfo":54,"targetDuration":4,"studyType":56,"phases":57,"briefSummary":59,"conditions":60,"keywords":4,"overallStatus":33,"whyStopped":4,"lastUpdateSubmitDate":62,"lastUpdatePostDateStruct":63,"startDateStruct":65,"completionDateStruct":67,"leadSponsor":69,"locationsCount":72},"100617671","phase-3-testing-the-addition-of-anti-cancer-drug-sonrotoclax-to-the-standard-treatment-zanubrutinib-for-previously-untreated-cllsll-100617671","NCT07321652","Testing the Addition of Anti-Cancer Drug Sonrotoclax, to the Standard Treatment Zanubrutinib, for Previously Untreated CLL\u002FSLL","Phase III Evaluation of Fixed Duration Zanubrutinib Plus Sonrotoclax-Based Therapy Compared to Continuous Zanubrutinib in Previously Untreated Older Patients With Chronic Lymphocytic Leukemia\u002FSmall Lymphocytic Lymphoma (CLL\u002FSLL)","Inclusion Criteria:\n\n* STEP 0: This bone marrow or peripheral blood submission to Adaptive is mandatory prior to registration\u002Frandomization for real-time identification of the clone needed for MRD testing. The bone marrow sample should be from the first aspiration (i.e., first pull). Aspirate needle should be redirected if needed to get first pull bone marrow aspirate. It should be obtained as soon after pre-registration as possible to confirm registration eligibility\n* STEP 0: Patients must be diagnosed with CLL\u002FSLL according to International Workshop on Chronic Lymphocytic Leukemia (IWCLL) 2018 criteria that includes all of the following:\n\n  * ≥ 5 x10\\^9 \u002FL B lymphocytes (5000\u002FμL) in the peripheral blood (CLL) or a lymph node biopsy demonstrating SLL with the below immunophenotype (SLL)\n  * On morphologic review, the leukemic cells must be small mature lymphocytes\n  * Immunophenotype of CLL cells (performed locally) must reveal a clonal B-cell population, which coexpress the B cell surface markers of CD19 and CD20, as well as the T-cell antigen CD5. Patients with bright surface immunoglobulin expression or lack of CD23 expression in \\> 10% of cells must lack t(11;14) translocation by interphase cytogenetics\n* STEP 0: Patients must meet criteria for treatment as defined by IWCLL 2018 guidelines which includes at least one of the following criteria:\n\n  * Evidence of marrow failure as manifested by the development or worsening of anemia or thrombocytopenia (not attributable to autoimmune hemolytic anemia or thrombocytopenia), typically hemoglobin (Hb) \\\u003C 10 g\u002FdL, platelet count \\\u003C 100,000\u002Fmm\\^3\n  * Massive (\\> 6 cm below the costal margin), progressive or symptomatic splenomegaly\n  * Massive nodes (ie, \\> 10 cm in longest diameter) or progressive or symptomatic lymphadenopathy\n  * Autoimmune anemia and\u002For thrombocytopenia that is poorly responsive to standard therapy\n  * Constitutional symptoms, which include any of the following:\n\n    * Unintentional weight loss of ≥ 10% within the previous 6 months\n    * Significant fatigue (ie. Eastern Cooperative Oncology Group \\[ECOG\\] performance status \\[PS\\] ≥ 2)\n    * Fevers \\>100.5 °F or 38.0°C for 2 weeks or more without evidence of infection\n    * Night sweats \\> 1 month without evidence of infection\n* STEP 0: Patients must not have had prior therapy for CLL (except palliative steroids or treatment of autoimmune complications of CLL with rituximab or steroids)\n* STEP 0: Treatment with rituximab and\u002For high-dose corticosteroids for autoimmune complications of CLL must be completed prior to enrollment. Palliative steroids must be at a dose not higher than 20 mg\u002Fday of prednisone or equivalent corticosteroid at the time of registration\n* STEP 0: Age ≥ 65 years\n* STEP 0: ECOG performance status ≤ 2\n* STEP 0: Patients with known HIV infection on effective anti-retroviral therapy with undetectable viral load within 6 months prior to registration are eligible for this trial\n* STEP 0: For patients with evidence of chronic hepatitis B virus (HBV) infection, the HBV viral load must be undetectable on suppressive therapy, if indicated\n* STEP 0: Patients with a history of hepatitis C virus (HCV), infection must have been treated and cured. For patients with HCV infection who are currently on treatment, they are eligible if they have an undetectable HCV viral load\n* STEP 0: Patients must not be receiving active systemic anticoagulation with warfarin. Patients must be off warfarin therapy for at least 5 half-lives washout and with normal INR prior to enrollment\n* STEP 0: Patients with known history or current symptoms of cardiac disease, or history of treatment with cardiotoxic agents, should have a clinical risk assessment of cardiac function using the New York Heart Association Functional Classification. To be eligible for this trial, patients must be class 2B or better.\n\nPatients with acute cardiac events within 6 months prior to registration should be carefully evaluated for their suitability for enrollment\n\n* STEP 0: No patients with a history of a severe bleeding disorder or a history of hemorrhagic stroke or intracranial hemorrhage\n* STEP 0: No patients with known active progressive central nervous system (CNS) disease\n* STEP 0: No known medical condition causing an inability to swallow oral formulations of agents\n* STEP 1: The adaptive report confirming a measurable and trackable B cell clone\n* STEP 1: Patients may not have had major surgery within 7 days of enrollment, or minor surgery within 5 days of enrollment. Examples of minor surgery include dental surgery, insertion of a venous access device, skin biopsy, or aspiration of a joint. The decision about whether a surgery is major or minor can be made at the discretion of the treating physician\n* STEP 1: No patients with ongoing active fungal, bacterial or viral infection requiring systemic therapy except those described in the protocol document\n* STEP 1: Patients must not require more than 20 mg prednisone or equivalent corticosteroid daily\n* STEP 1: Patients must not have uncontrolled active systemic infection requiring intravenous antibiotics\n* STEP 1: Patients must not have continued requirement for therapy with a strong CYP3A4\u002F5 inhibitor or inducer. Any such inhibitor or inducer must have been discontinued at least 14 days or 5 half-lives (whichever is shorter) before the first dose of study drug\n* STEP 1: Absolute neutrophil count (ANC) ≥ 1,000\u002Fmm3 unless due to marrow involvement\n* STEP 1: Platelet count ≥ 30,000\u002Fmm3\n* STEP 1: Total bilirubin ≤ 1.5 x upper limit of normal (ULN) (unless due to liver involvement, hemolysis or Gilbert's disease)\n* STEP 1: Aspartate aminotransferase (AST)(serum glutamic oxaloacetic transaminase \\[SGOT\\])\u002F alanine aminotransferase (ALT) (serum glutamic pyruvic transaminase \\[SGPT\\]) ≤ 3.0 x upper limit of normal (ULN) unless due to disease infiltration of the liver\n* STEP 1: Calculated (calc.) creatinine clearance by Chronic Kidney Disease Epidemiology Collaboration equation (CKD-EPI) ≥ 30 mL\u002Fmin\n* STEP 1: Urine protein to creatinine ratio \\\u003C 1 or urine protein ≤ 1+\n* STEP 2: Detectable MRD ≥ 10 residual clonal cells per million nucleated cells in peripheral blood at the C15 restaging evaluation from ClonoSEQ\n* STEP 2: Response of PR, PR-L, CR, CCR or CRi to zanubrutinib sonrotoclax therapy","65 Years",{"count":55,"type":21},466,"INTERVENTIONAL",[58],"PHASE3","This phase III trial compares the effect of adding sonrotoclax to zanubrutinib versus zanubrutinib alone for the treatment of patients with untreated chronic lymphoblastic leukemia (CLL)\u002Fsmall lymphocytic lymphoma (SLL). Sonrotoclax is in a class of medications called B-cell lymphoma-2 (BCL-2) inhibitors. It may stop the growth of cancer cells by blocking Bcl-2, a protein needed for cancer cell survival. Zanubrutinib is in a class of medications called kinase inhibitors. It blocks a protein called BTK, which is present on B-cell (a type of white blood cells) cancers such as mantel cell lymphoma at abnormal levels. This may help keep cancer cells from growing and spreading. Giving sonrotoclax and zanubrutinib may be more effective than zanubrutinib alone for the treatment of untreated CLL\u002FSLL.",[25,61],"Small Lymphocytic Leukemia","2026-07-01",{"date":64,"type":37},"2026-07-02",{"date":66,"type":37},"2026-04-30",{"date":68,"type":21},"2038-09-30",{"name":70,"class":71},"Alliance for Clinical Trials in Oncology","OTHER",152,{"id":74,"slug":75,"hasResults":12,"nctId":76,"briefTitle":77,"officialTitle":78,"acronym":4,"eligibilityCriteria":79,"healthyVolunteers":80,"sex":18,"minAge":81,"maxAge":82,"enrollmentInfo":83,"targetDuration":4,"studyType":22,"phases":4,"briefSummary":85,"conditions":86,"keywords":4,"overallStatus":33,"whyStopped":4,"lastUpdateSubmitDate":62,"lastUpdatePostDateStruct":148,"startDateStruct":149,"completionDateStruct":151,"leadSponsor":153,"locationsCount":154},"100464928","collecting-blood-samples-from-patients-with-and-without-cancer-to-evaluate-tests-for-early-cancer-detection-100464928","NCT05334069","Collecting Blood Samples From Patients With and Without Cancer to Evaluate Tests for Early Cancer Detection","Blinded Reference Set for Multicancer Early Detection Blood Tests","Inclusion Criteria:\n\n* Participants with a cancer diagnosis: Documentation of disease:\n\n  * Histologic documentation: Histologically confirmed diagnosis of invasive cancer\n  * Stage: Stage I-IV per American Joint Committee on Cancer (AJCC) 7th edition, with the exception of patients with leukemia, lymphoma, and multiple myeloma\n\n    * For leukemia: Type (chronic lymphocytic leukemia \\[CLL\\], chronic myeloid leukemia \\[CML\\], acute lymphoblastic lymphoma \\[ALL\\], acute myeloid leukemia \\[AML\\])\n    * For lymphoma: Stage I-IV based on Ann Arbor staging\n    * For multiple myeloma: Stage I, II, III based on Revised International Staging System (RISS)\n  * One of the following tumor types:\n\n    * Colorectal\n    * Bladder\n    * Head and neck\n    * Hepatobiliary\n    * Lung\n    * Lymphoma\n    * Leukemia\n    * Ovary \\*\\*\\* For these specific cancer types only, patients may be enrolled prior to histologic confirmation of malignancy. Sites are required to contact the study chairs to review appropriateness for enrollment\n    * Pancreas \\*\\*\\* For these specific cancer types only, patients may be enrolled prior to histologic confirmation of malignancy. Sites are required to contact the study chairs to review appropriateness for enrollment\n    * Multiple myeloma\n    * Gastric, esophageal or gastroesophageal\n    * Breast\n    * Thyroid\n    * Kidney\n\n      * For these specific cancer types only, patients may be enrolled prior to histologic confirmation of malignancy. Sites are required to contact the study chairs to review appropriateness for enrollment\n    * Endometrium\n    * Prostate\n    * Melanoma\n\n      \\*\\*\\* For these specific cancer types only, patients may be enrolled prior to histologic confirmation of malignancy. Sites are required to contact the study chairs to review appropriateness for enrollment\n    * Sarcoma\n* Participants with a cancer diagnosis: No prior definitive systemic or local anti-cancer intervention\n* Participants with a cancer diagnosis: Age \\>= 40 and =\\\u003C 75\n* Participants with a cancer diagnosis: No known current pregnancy by self-report\n* Participants with a cancer diagnosis: No known or prior history of in situ or invasive malignancy (excluding in situ non-melanoma skin cancers) other than the current cancer diagnosis\n* Participants with a cancer diagnosis: Willingness to provide blood samples for research use\n* Participants with a cancer diagnosis: Absence of medical contraindications to a research blood draw volume of 60 mL\n* Participants with a cancer diagnosis: No history of organ transplantation\n* Participants with a cancer diagnosis: Ability to read and comprehend English or Spanish\n\n  \\* Eligibility is restricted to individuals who can comprehend and read English or Spanish given that participation in the study will require the ability to read and complete questionnaires that are available only in those two languages\n* Participants without a cancer diagnosis and without suspicion of cancer: Age \\>= 40 and =\\\u003C 75\n* Participants without a cancer diagnosis and without suspicion of cancer: No known current pregnancy by self-report\n* Participants without a cancer diagnosis and without suspicion of cancer: No known or prior history of in situ or invasive malignancy (excluding in situ non-melanoma skin cancers)\n* Participants without a cancer diagnosis and without suspicion of cancer: Willingness to provide blood samples for research use\n* Participants without a cancer diagnosis and without suspicion of cancer: Absence of medical contraindications to a research blood draw volume of 60 mL\n* Participants without a cancer diagnosis and without suspicion of cancer: No history of organ transplantation\n* Participants without a cancer diagnosis and without suspicion of cancer: Ability to read and comprehend English or Spanish\n\n  \\* Eligibility is restricted to individuals who can comprehend and read English or Spanish given that participation in the study will require the ability to read and complete questionnaires that are available only in those two languages\n* Participants with a high suspicion of cancer: High suspicion of ovarian cancer, pancreatic cancer, kidney cancer, or melanoma by clinical and\u002For radiological assessment, with plans for histologic or cytologic confirmation within 28 days after study blood draw\n\n  \\* Examples of highly suspicious cases include: elevated CA125 and abnormal transvaginal ultrasound, suspicious renal or pancreatic mass on imaging, suspicious cutaneous lesion concerning for melanoma\n* Participants with a high suspicion of cancer: Central review of radiology reports and\u002For clinical documentation conducted by study chairs\n* Participants with a high suspicion of cancer: Age \\>= 40 and =\\\u003C 75\n* Participants with a high suspicion of cancer: No known current pregnancy by self-report\n* Participants with a high suspicion of cancer: No known or prior history of in situ or invasive malignancy (excluding in situ non-melanoma skin cancers) other than the current cancer diagnosis\n* Participants with a high suspicion of cancer: Willingness to provide blood samples for research use\n* Participants with a high suspicion of cancer: Absence of medical contraindications to a research blood draw volume of 60 mL\n* Participants with a high suspicion of cancer: No history or organ transplantation\n* Participants with a high suspicion of cancer: Ability to read and comprehend English or Spanish \\* Eligibility is restricted to individuals who can comprehend and read English and Spanish given that participation in the study will require the ability to read and complete questionnaires that are available only in those two languages",true,"40 Years","75 Years",{"count":84,"type":21},2000,"This study collects blood and tissue samples from patients with cancer and without cancer to evaluate tests for early cancer detection. Collecting and storing samples of blood and tissue from patients with and without cancer to study in the laboratory may help researchers develop tests for the early detection of cancers.",[87,88,89,90,91,92,25,93,94,95,96,97,98,99,100,101,102,103,104,105,106,107,108,109,110,111,112,113,114,115,116,117,118,119,120,121,122,123,124,125,126,127,128,129,130,131,132,133,134,135,136,137,138,139,140,141,142,143,144,145,146,147],"Acute Lymphoblastic Leukemia","Acute Myeloid Leukemia","Ann Arbor Stage I Lymphoma","Ann Arbor Stage II Lymphoma","Ann Arbor Stage III Lymphoma","Ann Arbor Stage IV Lymphoma","Chronic Myeloid Leukemia","Gastroesophageal Junction Adenocarcinoma","Head and Neck Carcinoma","Hematopoietic and Lymphoid Cell Neoplasm","Invasive Breast Carcinoma","Kidney Carcinoma","Malignant Hepatobiliary Neoplasm","Malignant Solid Neoplasm","Melanoma","Muscle-Invasive Bladder Carcinoma","RISS Stage I Plasma Cell Myeloma","RISS Stage II Plasma Cell Myeloma","RISS Stage III Plasma Cell Myeloma","Sarcoma","Stage I Bladder Cancer AJCC v6 and v7","Stage I Breast Cancer AJCC v7","Stage I Colorectal Cancer AJCC v6 and v7","Stage I Esophageal Cancer AJCC V7","Stage I Gastric Cancer AJCC V7","Stage I Lung Cancer AJCC v7","Stage I Ovarian Cancer AJCC v6 and v7","Stage I Pancreatic Cancer AJCC v6 and v7","Stage I Prostate Cancer AJCC v7","Stage I Uterine Corpus Cancer AJCC v7","Stage II Bladder Cancer AJCC v6 and v7","Stage II Breast Cancer AJCC v6 and v7","Stage II Colorectal Cancer AJCC v7","Stage II Esophageal Cancer AJCC v7","Stage II Gastric Cancer AJCC v7","Stage II Lung Cancer AJCC v7","Stage II Ovarian Cancer AJCC v6 and v7","Stage II Pancreatic Cancer AJCC v6 and v7","Stage II Prostate Cancer AJCC v7","Stage II Uterine Corpus Cancer AJCC v7","Stage III Bladder Cancer AJCC v6 and v7","Stage III Breast Cancer AJCC v7","Stage III Colorectal Cancer AJCC v7","Stage III Esophageal Cancer AJCC v7","Stage III Gastric Cancer AJCC v7","Stage III Lung Cancer AJCC v7","Stage III Ovarian Cancer AJCC v6 and v7","Stage III Pancreatic Cancer AJCC v6 and v7","Stage III Prostate Cancer AJCC v7","Stage III Uterine Corpus Cancer AJCC v7","Stage IV Bladder Cancer AJCC v7","Stage IV Breast Cancer AJCC v6 and v7","Stage IV Colorectal Cancer AJCC v7","Stage IV Esophageal Cancer AJCC v7","Stage IV Gastric Cancer AJCC v7","Stage IV Lung Cancer AJCC v7","Stage IV Ovarian Cancer AJCC v6 and v7","Stage IV Pancreatic Cancer AJCC v6 and v7","Stage IV Prostate Cancer AJCC v7","Stage IV Uterine Corpus Cancer AJCC v7","Thyroid Gland Carcinoma",{"date":64,"type":37},{"date":150,"type":37},"2022-08-18",{"date":152,"type":21},"2027-02-28",{"name":70,"class":71},745,{"id":156,"slug":157,"hasResults":12,"nctId":158,"briefTitle":159,"officialTitle":160,"acronym":4,"eligibilityCriteria":161,"healthyVolunteers":12,"sex":18,"minAge":162,"maxAge":4,"enrollmentInfo":163,"targetDuration":4,"studyType":56,"phases":165,"briefSummary":166,"conditions":167,"keywords":4,"overallStatus":33,"whyStopped":4,"lastUpdateSubmitDate":62,"lastUpdatePostDateStruct":169,"startDateStruct":170,"completionDateStruct":172,"leadSponsor":174,"locationsCount":177},"100383227","phase-3-testing-early-treatment-for-patients-with-high-risk-chronic-lymphocytic-leukemia-cll-or-small-lymphocytic-leukemia-sll-evolve-cllsll-study-100383227","NCT04269902","Testing Early Treatment for Patients With High-Risk Chronic Lymphocytic Leukemia (CLL) or Small Lymphocytic Leukemia (SLL), EVOLVE CLL\u002FSLL Study","Randomized, Phase III Study of Early Intervention With Venetoclax and Obinutuzumab Versus Delayed Therapy With Venetoclax and Obinutuzumab in Newly Diagnosed Asymptomatic High-Risk Patients With Chronic Lymphocytic Leukemia\u002FSmall Lymphocytic Lymphoma (CLL\u002FSLL): EVOLVE CLL\u002FSLL Study","Inclusion Criteria:\n\n* Participants must have a confirmed diagnosis of chronic lymphocytic leukemia (CLL) or small lymphocytic lymphoma (SLL) (collectively referred to as CLL throughout) according to the 2018 International Workshop on CLL. Participants must have been diagnosed within 18 months prior to registration\n* Participants must have CLL-International Prognostic Index (CLL-IPI) score \\>= 4 and\u002For complex cytogenetics (defined as 3+ chromosomal abnormalities)\n* Cytogenetic AND\u002FOR FISH analyses must be completed at a Clinical Laboratory Improvement Act (CLIA)-approved (or laboratories accredited under Accreditation Canada Diagnostics to conduct FISH analyses) laboratory within 18 months prior to registration. At minimum, FISH panel should use probes to detect for abnormalities in chromosomes 13q, 12, 11q, and 17p\n* TP53 gene mutation analysis performed at any CLIA-approved (or laboratories accredited under Accreditation Canada Diagnostics) lab (if completed) must be obtained within 18 months prior to registration. This sequencing test is distinct from FISH studies for del(17p)\n\n  * Note: TP53 gene mutation analysis is recommended but not required if the participant meets disease-related study criteria via a combination of risk factors that totals a score of 4 on the CLL-IPI score and\u002For has complex cytogenetics completed\n* Immunoglobulin heavy chain locus variable (IgVH) gene mutation analysis performed at any CLIA-approved lab (or laboratories accredited under Accreditation Canada Diagnostics) must be obtained prior to registration (at any time prior to registration)\n* Serum beta-2 microglobulin level must be obtained within 28 days prior to registration\n* Participants must not meet any of the IWCLL specified criteria for active CLL therapy\n* Treatment with high dose corticosteroids and\u002For intravenous immunoglobulin for autoimmune complications of CLL must be complete at least 4 weeks prior to enrollment\n* Steroids used for treatment of conditions other than CLL\u002FSLL must be at a dose of at most 20 mg\u002Fday of prednisone or equivalent corticosteroid at the time of registration\n* Prior therapy with anti CD20 monoclonal antibodies is not allowed\n* Participants must not have received or be currently receiving any prior CLL-directed therapy, including non-protocol-related therapy, anti-cancer immunotherapy, experimental therapy (with exception of agents approved for emergency access use for the prevention or treatment of coronavirus disease 2019 \\[COVID-19\\]), or radiotherapy\n* Participants must not be receiving or planning to receive any other investigational agents before completing protocol therapy\n* Participants must be \\>= 18 years of age\n* Participants must have Eastern Cooperative Oncology Group (ECOG) performance status =\\\u003C 2\n* Platelet count \\>= 100,000\u002Fmm\\^3 within 28 days prior to registration\n* Absolute neutrophil count (ANC) \\>= 1,000\u002Fmm\\^3 within 28 days prior to registration\n* Creatinine clearance \\>= 30mL\u002Fmin (by Cockcroft Gault) within 28 days prior to registration\n* Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) \\\u003C 3.0 x upper limit of normal (ULN) within 28 days prior to registration\n* Total bilirubin =\\\u003C 2.0 x ULN (or 5.0 x ULN if the participant has a history of Gilbert's disease), within 28 days prior to registration\n* Participants must be able to take oral medications\n* Human immunodeficiency virus (HIV)-infected participants on effective anti-retroviral therapy with undetectable viral load within 6 months are eligible for this trial\n* Participants with history of malignancy are allowed providing the cancer has not required active treatment within 2 years prior to registration (hormonal therapy is permissible). The following exceptions are permissible: basal cell, squamous cell skin, or non-melanomatous skin cancer, in situ cervical cancer, superficial bladder cancer not treated with intravesical chemotherapy or Bacillus Calmette-Guerin (BCG) within 6 months, localized prostate cancer treated with surgical resection and\u002For radiation only or requiring no more than chronic hormonal therapy, or prostate cancer with Gleason score ≤ 6, or localized breast cancer treated with surgical resection and\u002For radiation only or requiring no more than chronic hormonal therapy\n* Participants must not have current, clinically significant gastrointestinal malabsorption, in the opinion of treating doctor\n* Participants must not have cirrhosis\n* Obinutuzumab has been associated with hepatitis reactivation. Participants must not have uncontrolled active infection with hepatitis B or C. Participants with latent hepatitis B infection must agree to take prophylaxis during and for 6 months following active protocol therapy with V-O.\n\n  * Active infection with hepatitis B or C:\n\n    * Active infection is defined as detectable hepatitis B deoxyribonucleic acid (DNA) or hepatitis C ribonucleic acid (RNA) by quantitative polymerase chain reaction (PCR).\n  * Latent infection with hepatitis B:\n\n    * Latent infection is defined as meeting all of the following criteria:\n\n      * Hepatitis B surface antigen positive\n      * Anti-hepatitis B total core antibody positive\n      * Anti-hepatitis IgM core antibody undetectable\n      * Hepatitis B PCR undetectable\n    * Participants with latent hepatitis B infection must agree to take prophylaxis with anti-hepatitis agents during and for 6 months following active protocol therapy with V-O.\n    * Participants who have received intravenous immunoglobulin (IVIG) therapy within 6 months who are hepatitis B core total antibody positive but PCR undetectable are not mandated to take prophylaxis\n* Participants must not have had major surgery within 30 days prior registration or minor surgery within 7 days prior to registration. Examples of major surgery include neurosurgical procedures, joint replacements, and surgeries that occur inside the thoracic or abdomino-pelvic cavities. Examples of minor surgery include dental surgery, insertion of a venous access device, skin biopsy, or aspiration of a joint. If a participant has had a bone marrow biopsy for diagnosis or evaluation of CLL, this will not exclude the participant from registration to the study. If there is a question about whether a surgery is major or minor, this should be discussed with the Study Chair\n* Participants must not have known bleeding disorders (e.g., von Willebrand's disease or hemophilia)\n* Participants must not have a history of stroke or intracranial hemorrhage within 6 months prior to enrollment\n* Participants must not require continued therapy with a strong inhibitor or inducer of CYP3A4\u002F5, as venetoclax is extensively metabolized by CYP3A4\u002F5\n* Participants must not have uncontrolled autoimmune hemolytic anemia or idiopathic thrombocytopenia purpura\n* Participants must not have any currently active, clinically significant cardiovascular disease, such as uncontrolled arrhythmia or class 3 or 4 congestive heart failure as defined by the New York Heart Association Functional Classification\n* Participants must not have a history of myocardial infarction, unstable angina, or acute coronary syndrome within 6 months prior to enrollment\n* Participants must not be pregnant or nursing, as there are no safety data available for these drug regimens during pregnancy. Women\u002Fmen of reproductive potential must have agreed to use an effective contraceptive method. A woman is considered to be of \"reproductive potential\" if she has had menses at any time in the preceding 12 consecutive months. In addition to routine contraceptive methods, \"effective contraception\" also includes heterosexual celibacy and surgery intended to prevent pregnancy (or with a side-effect of pregnancy prevention) defined as a hysterectomy, bilateral oophorectomy or bilateral tubal ligation. However, if at any point a previously celibate participant chooses to become heterosexually active during the time period for use of contraceptive measures outlined in the protocol, he\u002Fshe is responsible for beginning contraceptive measures\n* Participants must agree to have specimens submitted for translational medicine (MRD) as outlined\n* Participants must be offered the opportunity to participate in specimen banking for future research as outlined.\n\n  * NOTE: With participant's consent, the site must follow through with specimen submission as outlined\n* Participants who are able to complete patient reported outcome (PRO) forms in English, Spanish, French, German, Russian or Mandarin must be offered the opportunity to participate in the quality of life assessments. (Those participants who are unable to read and write in English, Spanish, French, German, Russian or Mandarin may be registered to S1925 without contributing to the quality of life portion of the study.)\n* Participants must be informed of the investigational nature of this study and must sign and give written informed consent in accordance with institutional and federal guidelines\n* NOTE: As a part of the Oncology Patient Enrollment Network (OPEN) registration process the treating institution's identity is provided in order to ensure that the current (within 365 days) date of institutional review board approval for this study has been entered in the system","18 Years",{"count":164,"type":21},247,[58],"This phase III trial compares early treatment with venetoclax and obinutuzumab versus delayed treatment with venetoclax and obinutuzumab in patients with newly diagnosed high-risk chronic lymphocytic leukemia or small lymphocytic lymphoma. Venetoclax is in a class of medications called B-cell lymphoma-2 (BCL-2) inhibitors. It may stop the growth of cancer cells by blocking Bcl-2, a protein needed for cancer cell survival. Immunotherapy with monoclonal antibodies, such as obinutuzumab, may help the body's immune system attack the cancer, and may interfere with the ability of tumor cells to grow and spread. Starting treatment with the venetoclax and obinutuzumab early (before patients have symptoms) may have better outcomes for patients with chronic lymphocytic leukemia or small lymphocytic lymphoma compared to starting treatment with the venetoclax and obinutuzumab after patients show symptoms.",[25,168],"Small Lymphocytic Lymphoma",{"date":64,"type":37},{"date":171,"type":37},"2021-03-02",{"date":173,"type":21},"2028-10-01",{"name":175,"class":176},"National Cancer Institute (NCI)","NIH",631,{"id":179,"slug":180,"hasResults":12,"nctId":181,"briefTitle":182,"officialTitle":183,"acronym":4,"eligibilityCriteria":184,"healthyVolunteers":80,"sex":18,"minAge":162,"maxAge":82,"enrollmentInfo":185,"targetDuration":4,"studyType":56,"phases":187,"briefSummary":189,"conditions":190,"keywords":4,"overallStatus":33,"whyStopped":4,"lastUpdateSubmitDate":200,"lastUpdatePostDateStruct":201,"startDateStruct":202,"completionDateStruct":203,"leadSponsor":205,"locationsCount":207},"100594521","phase-1-a-vaccine-cmv-mva-triplex-vaccine-for-the-enhancement-of-cmv-specific-immunity-and-the-prevention-of-cmv-viremia-in-patients-undergoing-haploidentical-hematopoietic-stem-cell-transplant-100594521","NCT07020533","A Vaccine (CMV-MVA Triplex Vaccine) for the Enhancement of CMV-Specific Immunity and the Prevention of CMV Viremia in Patients Undergoing Haploidentical Hematopoietic Stem Cell Transplant","A Phase 1b Trial of CMV-MVA Triplex Vaccine in Haploidentical Stem Cell Donors and Recipients to Enhance CMV-Specific Immunity and Prevent CMV Viremia in Recipients of Hematopoietic Stem Cell Transplant","Inclusion Criteria:\n\n* DONORS: Documented informed consent of the participant. This can be done in person or informed consent can be obtained remotely.\n\n  * Remote consent, when appropriate, will be obtained per institutional guidelines.\n  * Assent, when appropriate, will be obtained per institutional guidelines.\n  * Adult subjects who require a legally authorized representative (LAR) will not be permitted to be enrolled under this protocol.\n* DONORS: Age: 18 - 75.\n* DONORS: Women of childbearing potential (WOCBP): negative urine or serum pregnancy test. If the urine test is positive or cannot be confirmed as negative, a serum pregnancy test will be required.\n* DONORS: Agreement by females and males of childbearing potential\\* to use an effective method of birth control (hormonal or barrier method) or abstain from heterosexual activity prior to study entry and for up to 90 days post-vaccination.\n\n  * Childbearing potential defined as not being surgically sterilized (men and women) or have not been free from menses for \\> 1 year (women only).\n* RECIPIENTS: Documented informed consent of the participant and\u002For legally authorized representative. This can be done in person or informed consent can be obtained remotely.\n\n  * Remote consent, when appropriate, will be obtained per institutional guidelines.\n  * Assent, when appropriate, will be obtained per institutional guidelines.\n  * Adult subjects who require a legally authorized representative (LAR) will not be permitted to be enrolled under this protocol.\n* RECIPIENTS: Participant must be willing to comply with study and\u002For follow-up procedures, including willingness to be followed for one year post-HCT.\n* RECIPIENTS: Age: 18 - 75.\n* RECIPIENTS: Planned peripheral blood stem cell (PBSC) or bone marrow (BM) HCT for the treatment of the following hematologic malignancies:\n\n  * Lymphoma (Hodgkin and Non-Hodgkin).\n  * Myelodysplastic syndrome.\n  * Acute lymphoblastic leukemia in first or second remission (for acute lymphoblastic leukemia\u002Flymphoblastic lymphoma, the disease status must be in hematologic remission by bone marrow and peripheral blood. Persistent lymphadenopathy on computed tomography (CT) or CT\u002Fpositron emission tomography(PET) scan without progression is allowed.)\n  * Acute myeloid leukemia in first or second remission.\n  * Chronic myelogenous leukemia in first chronic or accelerated phase, or in second chronic phase.\n  * Other hematologic malignancies judged appropriate by the clinical principal investigators (PIs), including chronic lymphocytic leukemia, myeloproliferative disorders and myelofibrosis. Patients with multiple myeloma and those with non-malignant disease such as aplastic anemia are excluded\\*\\*.\n\n    * Adult cases of multiple myeloma (MM) are excluded as HCT is not standard of care for MM and is only performed in very advanced cases with an associated high risk of relapse and non-relapse mortality (NRM). Adults with aplastic anemia are excluded because their standard management includes T cell depletion with agents such as antithymocyte globulin (ATG), which is not permissible on this protocol. Patients undergoing a second haploHCT are not eligible (patients who have undergone a previous autologous HCT are eligible).\n* RECIPIENTS: Patients receiving myeloablative (MA) or reduced intensity conditioning (RIC) are allowed.\n* RECIPIENTS: CMV seropositive.\n* RECIPIENTS: Eligible haploidentical donors will have 2-4 mismatches if human leukocyte antigen (HLA)-A, -B, -C, and -DRB1 typing is used; 2-5 mismatches if HLA-A, -B, -C, -DRB1, and -DQB1 typing is used; and 2-6 mismatches if HLA-A, -B, -C, -DRB1, -DQB1, and -DPB1 typing is used. A unidirectional mismatch in either the graft versus host or host versus graft direction is considered a mismatch. The donor and recipient must demonstrate that they are a full haplotype match by being identical at a minimum of one allele (at high resolution deoxyribonucleic acid \\[DNA\\]-based typing) at the following genetic loci: HLA-A, -B, -C, and DRB1 if 8 allele typing is used; HLA-A, -B, -C, -DRB1, and -DQB1 if 10 allele typing is used; and HLA-A, -B, -C, -DRB1-, DQB1, and -DPB1 is 12 allele typing is used.\n* RECIPIENTS: Planned HCT with minimal to no-T cell depletion of graft.\n* RECIPIENTS: Conditioning and immunosuppressive regimens according to institutional guidelines are permitted.\n* RECIPIENTS: Total bilirubin ≤ 1.5 X upper limit of normal (ULN) (unless has Gilbert's disease) (to be performed within 45 days prior to day 1 of protocol therapy).\n* RECIPIENTS: Aspartate aminotransferase (AST) =\\\u003C 2.5 x ULN (to be performed within 45 days prior to day 1 of protocol therapy).\n* RECIPIENTS: Alanine aminotransferase (ALT) =\\\u003C 2.5 x ULN (to be performed within 45 days prior to day 1 of protocol therapy).\n* RECIPIENTS: Estimated creatinine clearance acceptable per institutional guidelines (to be performed within 45 days prior to day 1 of protocol therapy).\n* RECIPIENTS: Left ventricular ejection fraction (LVEF) ≥ 50%.\n\n  * Note: To be performed within 45 days prior to day 1 of protocol therapy.\n* RECIPIENTS: If able to perform pulmonary function tests: forced expiratory volume in 1 second (FEV1), forced vital capacity (FVC) and carbon monoxide diffusing capability (DLCO) (diffusion capacity) ≥ 50% of predicted (corrected for hemoglobin).\n\n  * If unable to perform pulmonary function tests: Oxygen (O2) saturation \\> 92% on room air.\n  * Note to be performed within 45 days prior to day 1 of protocol therapy.\n* RECIPIENTS: Seronegative for HIV antigen (Ag)\u002Fantibody (Ab) combination (combo), hepatitis c virus (HCV)\\*, active hepatitis b virus (HBV) (surface antigen negative) and syphilis (RPR) within 2 months of registration and no history of disseminated cutaneous human papillomavirus (HPV) related disease.\n\n  * If seropositive for HIV, HCV or HBV, nucleic acid quantitation must be performed. Viral load must be undetectable.\n* RECIPIENTS: Meets other institutional and federal requirements for infectious disease titer requirements.\n\n  * Note Infectious disease testing to be performed within 45 days prior to day 1 of protocol therapy.\n* RECIPIENTS: Women of childbearing potential (WOCBP): negative urine or serum pregnancy test. If the urine test is positive or cannot be confirmed as negative, a serum pregnancy test will be required (to be performed within 45 days prior to day 1 of protocol therapy).\n* RECIPIENTS: Agreement by females and males of childbearing potential\\* to use an effective method of birth control (hormonal or barrier method) or abstain from heterosexual activity prior to study entry and up to 90 days post-HCT.\n\n  * Childbearing potential defined as not being surgically sterilized (men and women) or have not been free from menses for \\> 1 year (women only).\n\nExclusion Criteria:\n\n* DONORS: Any prior transplant to day 1 of protocol therapy (day 1 defined as the day after donors receive the Triplex vaccine).\n* DONORS: Chemotherapy, radiation therapy, biological therapy, immunotherapy within 21 days prior to day 1 of protocol therapy.\n* DONORS: Receipt of any vaccine (licensed or investigational) within 30 days prior to and after the study vaccine.\n* DONORS: Unfit to undergo standard stem cell mobilization and apheresis e.g. abnormal blood counts, history of stroke, uncontrolled hypertension.\n* DONORS: Sickling hemoglobinopathy including hemoglobin (Hb)SS, HbAS, HbSC.\n* DONORS: Donors with impaired cardiac function are excluded. Electrocardiography is routine for potential HCT donors over 60 years old and those with a history of heart disease. Subjects in whom cardiac function is abnormal (excluding 1st degree branch block, sinus bradycardia, sinus tachycardia or non-specific T wave changes) are ineligible for Triplex vaccination.\n* DONORS: Severe psychiatric illness. Mental deficiency sufficiently severe as to make compliance with the donation procedure unlikely and making informed consent impossible.\n* DONORS: Females only: Pregnant or breastfeeding.\n* DONORS: Any other condition that would, in the investigator's judgment, contraindicate the patient's participation in the clinical study due to safety concerns with clinical study procedures.\n* DONORS: Prospective participants who, in the opinion of the investigator, may not be able to comply with all study procedures (including compliance issues related to feasibility\u002Flogistics).\n* RECIPIENTS: Any prior investigational CMV vaccine.\n* RECIPIENTS: Experimental anti-CMV chemotherapy in the last 6 months.\n* RECIPIENTS: Live attenuated vaccines (planned medications from the time of HCT to day 70 post-HCT).\n* RECIPIENTS: Medically indicated subunit (Engerix-B for HBV; Gardasil for HPV) or killed vaccines (e.g. influenza, pneumococcal, or allergy treatment with antigen injections) (planned medications from the time of HCT to day 70 post-HCT).\n* RECIPIENTS: Allergy treatment with antigen injections (planned medications from the time of HCT to day 70 post-HCT).\n* RECIPIENTS: Alemtuzumab or any equivalent in vivo T-cell depleting agent (or CD34+ selection) (planned medications from the time of HCT to day 70 post-HCT).\n* RECIPIENTS: Antiviral medications with known therapeutic effects on CMV such as ganciclovir (GCV)\u002Fvalganciclovir (VAL), foscarnet (FOS), cidofovir, CMX-001, maribavir. Acyclovir has no known therapeutic efficacy against CMV and is allowable as standard of care to prevent herpes simplex virus (HSV) (planned medications from the time of HCT to day 70 post-HCT).\n* RECIPIENTS: Prophylactic therapy with CMV immunoglobulin or prophylactic antiviral CMV treatment EXCEPT letermovir prophylaxis (prior to day 100) (planned medications from the time of HCT to day 70 post-HCT).\n* RECIPIENTS: Disease-based radiation therapy (not total body irradiation) (planned medications from the time of HCT to day 70 post-HCT).\n* RECIPIENTS: Other investigational product(s) - concurrent enrollment in other clinical trials using any investigational new drug (IND) drugs with unknown effects on CMV or with unknown toxicity profiles is prohibited (planned medications from the time of HCT to day 70 post-HCT).\n* RECIPIENTS: Other medications that might interfere with the evaluation of the investigational product (planned medications from the time of HCT to day 70 post-HCT).\n* RECIPIENTS: Patients with active autoimmune conditions requiring systemic immunosuppressive therapy within the previous 5 years.\n* RECIPIENTS: Patients considered by PI\u002Fconsenting physicians to have a complicated prior therapy or HCT regimen, or who have a low survival probability (e.g., refractory leukemia and\u002For undergoing 2nd HCT).\n* RECIPIENTS: Poor risk disease\u002Fdisease status including: Chronic myelogenous leukemia (CML) in blast crisis, acute myeloid leukemia (AML)\u002Facute lymphoblastic leukemia (ALL) beyond 2nd remission, multiple myeloma, and aplastic anemia.\n* RECIPIENTS: Females only: Pregnant or breastfeeding.\n* RECIPIENTS: Any other condition that would, in the investigator's judgment, contraindicate the patient's participation in the clinical study due to safety concerns with clinical study procedures.\n* RECIPIENTS: Prospective participants who, in the opinion of the investigator, may not be able to comply with all study procedures (including compliance issues related to feasibility\u002Flogistics).",{"count":186,"type":21},46,[188],"PHASE1","This phase Ib trial tests the safety, side effects, and how well cytomegalovirus (CMV)-modified vaccinia Ankara (MVA) Triplex vaccine works in enhancing CMV-specific immunity and preventing CMV viremia in patients undergoing haploidentical hematopoietic stem cell transplant. Haploidentical stem cell transplantation (haploHCT) has advanced to become the predominant procedure for patients lacking a matched donor. Compared to matched related donor transplants, the rate of significant CMV infection is higher in patients undergoing a haploHCT. Significant CMV infection is associated with an increased risk of complications and death. Vaccination is the main preventative approach to limit complications and death in immunocompromised patients at high risk of post-stem cell transplant infections. CMV-MVA Triplex vaccine, is a CMV vaccine based on the attenuated poxvirus, modified vaccinia Ankara (MVA), developed to enhance CMV-specific immunity in both healthy stem cell transplant donors and stem cell transplant patients to prevent significant CMV infection post-stem cell transplant. Giving CMV-MVA triplex vaccine may be safe, tolerable and\u002For effective in enhancing cytomegalovirus (CMV)-specific immunity and preventing CMV viremia in patients undergoing a haploHCT.",[191,87,88,25,192,193,194,195,196,197,198,199],"Accelerated Phase Chronic Myeloid Leukemia, BCR-ABL1 Positive","Chronic Phase Chronic Myeloid Leukemia, BCR-ABL1 Positive","Hematopoietic and Lymphatic System Neoplasm","Hodgkin Lymphoma","Lymphoblastic Lymphoma","Myelodysplastic Syndrome","Myelofibrosis","Myeloproliferative Neoplasm","Non-Hodgkin Lymphoma","2026-06-30",{"date":64,"type":37},{"date":200,"type":37},{"date":204,"type":21},"2028-05-30",{"name":206,"class":71},"City of Hope Medical Center",3,{"id":209,"slug":210,"hasResults":12,"nctId":211,"briefTitle":212,"officialTitle":213,"acronym":4,"eligibilityCriteria":214,"healthyVolunteers":12,"sex":18,"minAge":162,"maxAge":4,"enrollmentInfo":215,"targetDuration":4,"studyType":56,"phases":216,"briefSummary":218,"conditions":219,"keywords":4,"overallStatus":220,"whyStopped":4,"lastUpdateSubmitDate":221,"lastUpdatePostDateStruct":222,"startDateStruct":223,"completionDateStruct":225,"leadSponsor":227,"locationsCount":45},"100635774","phase-2-nemtabrutinib-and-venetoclax-for-the-treatment-of-patients-with-chronic-lymphocytic-leukemia-or-small-lymphocytic-lymphoma-100635774","NCT07557056","Nemtabrutinib and Venetoclax for the Treatment of Patients With Chronic Lymphocytic Leukemia or Small Lymphocytic Lymphoma","A Phase 2 Study of Nemtabrutinib and Venetoclax as Frontline Treatment for Chronic Lymphocytic Leukemia (CLL)","Inclusion Criteria:\n\n* Confirmed diagnosis of CLL\u002FSLL meeting criteria established in the 2018 International Workshop on Chronic Lymphocytic Leukemia (iwCLL) guidelines\n* Is an individual of any sex\u002Fgender, who is at least 18 years of age on the day of signing informed consent\n* Participants must have treatment-naïve CLL\u002FSLL. Palliative loco-regional radiotherapy, rituximab for autoimmune conditions, or corticosteroids for symptom control will not be considered prior therapy\n* Participants must meet criteria for treatment as defined by 2018 iwCLL guidelines which includes at least one of the following criteria:\n\n  * Massive (\\>= 6 cm below the costal margin), progressive or symptomatic splenomegaly\n  * Massive nodes (\\>= 10 cm) or progressive or symptomatic lymphadenopathy\n  * Progressive lymphocytosis with a lymphocyte doubling time \\\u003C 6 months or an increase of \\>= 50% over a 2 month period\n  * Autoimmune anemia and\u002For thrombocytopenia that is poorly responsive to standard therapy\n  * Symptomatic or functional extranodal involvement (e.g. skin, kidney, lung, spine)\n  * Constitutional symptoms, which include any of the following:\n\n    * Unintentional weight loss of 10% or more within 6 months\n    * Significant fatigue\n    * Fevers \\> 100.5 degrees Fahrenheit (F) for 2 weeks or more without evidence of infection\n    * Night sweats \\>= 1 month without evidence of infection\n* Eastern Cooperative Oncology Group (ECOG) performance status ≤ 2. Evaluation of ECOG is to be performed within 7 days prior to the first dose of study intervention\n* Adequate bone marrow independent of growth factor support or infusion support at screening unless evidence shows that the cytopenia(s) is due to marrow involvement by CLL\u002FSLL and\u002For disease-related immune thrombocytopenia, or anemia. If cytopenias are due to disease in the bone marrow any degree of cytopenias are allowed. Patients with active uncontrolled autoimmune cytopenias are excluded\n* Absolute neutrophil count (ANC) \\>= 1000\u002Fmm\\^3\n* Platelets \\>= 50,000\u002Fmm\\^3\n* Hemoglobin \\>= 8 g\u002FdL\n* Willing and able to participate in all required evaluations and procedures in this study protocol\n* Ability to understand the purpose and risks of the study and provide signed and dated informed consent and authorization to use protected health information\n* Participants assigned male sex at birth: If capable of producing sperm, the participant agrees to the following during the intervention period and for at least the time needed to eliminate each study intervention after the last dose of study intervention. The length of time required to continue contraception for each study intervention is:\n\n  * Nemtabrutinib: 12 days\n  * Abstains from penile-vaginal intercourse as their preferred and usual lifestyle (abstinent on a long-term and persistent basis) and agrees to remain abstinent OR\n  * Uses contraception as detailed below unless confirmed to be azoospermic (vasectomized or secondary to medical cause, documented from the site personnel's review of the participant's medical records, medical examination, or medical history interview) as detailed below:\n  * Uses a penile\u002Fexternal condom plus nonparticipant of childbearing potential who is not currently pregnant and should also be advised of the benefit for that partner to use an additional method of contraception, as a condom may break or leak.\n\n    * Note: Participants capable of producing ejaculate whose partner is pregnant or breastfeeding must agree to use penile\u002Fexternal condom during each episode of sexual activity in which the partner is at risk of drug exposure via ejaculate.\n  * Contraceptive use by participants capable of producing sperm should be consistent with local regulations regarding the methods of contraception for those participating in clinical studies. If the contraception requirements in the local label for any of the study interventions are more stringent than the requirements above, the local label requirements are to be followed\n* Participants assigned female sex at birth: A participant assigned female sex at birth is eligible to participate if not pregnant or breastfeeding, and at least one of the following conditions applies:\n\n  * Is not a person of childbearing potential (POCBP) OR\n  * Is a POCBP and:\n\n    * Uses a contraceptive method that is highly effective (with a failure rate of \\\u003C 1% per year), with low user dependency, or is abstinent from penile-vaginal intercourse as their preferred and usual lifestyle (abstinent on a long-term and persistent basis), during the intervention period and for at least the time needed to eliminate each study intervention after the last dose of study intervention. The length of time required to continue contraception for each study intervention is:\n\n      * Nemtabrutinib: 1 month\n    * The investigator should evaluate the potential for contraceptive method failure (i.e., noncompliance, recently initiated) in relationship to the first dose of study intervention. Contraceptive use by POCBPs should be consistent with local regulations regarding the methods of contraception for those participating in clinical studies. If the contraception requirements in the local label for any of the study interventions are more stringent than the requirements above, the local label requirements are to be followed.\n    * Has a negative highly sensitive pregnancy test (urine or serum) as required by local regulations within 24 hours (for urine test) or 72 hours (for serum test) before the first dose of study intervention. If a urine test cannot be confirmed as negative (e.g., an ambiguous result), a serum pregnancy test is required. In such cases, the participant must be excluded from participation if the serum pregnancy result is positive.\n    * Abstains from breastfeeding during the study intervention period and for at least 30 days after study intervention with nemtabrutinib.\n    * Medical history, menstrual history, and recent sexual activity has been reviewed by the investigator to decrease the risk for inclusion of a POCBP with an early undetected pregnancy\n* The ability to swallow and retain oral medication.\n\n  * NOTE: Administration of nemtabrutinib is not permitted through a percutaneous endoscopic gastro-jejunostomy (J-PEG) tube\n* Participants who are hepatitis B surface antigen (HbsAg) positive are eligible if they have received hepatitis B viral (HBV) antiviral therapy for at least 4 weeks and have undetectable HBV viral load prior to screening.\n\n  * Note: Participants should remain on anti-viral therapy throughout study intervention and follow local guidelines for HBV anti-viral therapy post completion of study intervention. Hepatitis B screening tests, including HBsAg and anti-HBc (hepatitis B core), are required for all participants\n* Participants with history of hepatitis C virus (HCV) infection are eligible if HCV viral load is undetectable at screening.\n\n  * Participants must have completed curative anti-viral therapy at least 4 weeks prior to randomization.\n  * Hepatitis C screening tests are not required unless:\n\n    * Known history of HCV infection\n    * As mandated by local health authority\n* Participants with human immunodeficiency virus (HIV) are eligible if they meet ALL of the following criteria:\n\n  * The CD4 count is \\> 350 cells\u002FìL at screening\n  * The HIV viral load is below the detectable level as per locally available testing\n  * Are on a stable antiretroviral therapy (ART) regimen for at least 4 weeks prior to study entry\n  * NOTE: ART includes drugs, which are NOT strong CYP3A4 inducers (participants receiving ART that are strong CYP3A4 inducers are not eligible to be included in the study).\n  * HIV screening tests are not required unless:\n\n    * Known history of HIV infection\n    * As mandated by local health authority\n  * Are compliant with their ART\n  * NOTE: If the participant has had an acquired immunodeficiency syndrome (AIDS) defining opportunistic infection in the past 12 months prior to screening, they are not eligible to be included in the study\n* Absolute neutrophil count (ANC) \\>= 1000\u002FuL\n\n  * Growth factor and\u002For transfusion support is permissible to stabilize participant prior to study treatment if needed.\n  * No lower limit if cytopenia is related to bone marrow involvement\n* Platelets \\>= 50000\u002FuL\n\n  * Growth factor and\u002For transfusion support is permissible to stabilize participant prior to study treatment if needed.\n  * No lower limit if cytopenia is related to bone marrow involvement\n* Hemoglobin \\>= 8 g\u002FdL\n\n  * Growth factor and\u002For transfusion support is permissible to stabilize participant prior to study treatment if needed.\n  * No lower limit if cytopenia is related to bone marrow involvement\n* Creatinine clearance (CrCl) \\>= 30mL\u002Fmin\n* Total bilirubin ≤ 1.5 × upper limit of normal (ULN) OR direct bilirubin ≤ ULN for participants with total bilirubin levels \\> 1.5 × ULN\n* Aspartate aminotransferase (AST) (serum glutamic oxaloacetic transaminase \\[SGOT\\]) and alanine aminotransferase (ALT) (serum glutamic pyruvic transaminase \\[SGPT\\]) =\\\u003C 2.5 x ULN (=\\\u003C 5 x ULN for participants with liver metastases)\n* International normalized ratio (INR) OR prothrombin time (PT) activated partial thromboplastin time (aPTT) =\\\u003C 1.5 x ULN unless participant is receiving anticoagulant therapy as long as PT or partial thromboplastin time (PTT) is within therapeutic range of intended use of anticoagulants\n\nExclusion Criteria:\n\n* Subject with other malignancies that are associated with a life expectancy of \\\u003C 2 years or that would confound assessment of toxicity in this study.\n\n  * NOTE: The time requirement does not apply to participants who underwent successful definitive resection of basal cell carcinoma of the skin, squamous cell carcinoma of the skin, or carcinoma in situ, excluding carcinoma in situ of the bladder\n* Clinically significant cardiovascular disease such as symptomatic arrhythmias, congestive heart failure, or myocardial infarction within 6 months of screening, or any class 3 or 4 cardiac disease as defined by the New York Heart Association Functional Classification. Note: Subjects with controlled atrial fibrillation can enroll on study\n* Active HBV\u002FHCV infection\n* Inability to swallow oral medication or gastrointestinal dysfunction that may affect drug absorption (e.g., gastric bypass surgery, gastrectomy)\n* Diagnosis of Richter transformation\n* Active central nervous system (CNS) involvement\n* Active infection requiring systemic therapy, including intravenous (IV) antibiotics during screening. Participants may be rescreened followed completion of IV antibiotic course\n* AIDS defining opportunistic infection in the past 12 months prior to screening\n* History or current evidence of any condition, therapy, or laboratory abnormality that might confound the results of the study, interfere with the participant's participation for the full duration of the study, or is not in the best interest of the participant to participate, in the opinion of the treating investigator\n* Corrected QT (QTc) prolongation (defined as a Fridericia-corrected QT interval \\[QTcF\\] \\> 450 msecs) or other significant electrocardiogram (ECG) abnormalities including second degree atrioventricular (AV) block type II, third degree AV block, or bradycardia (ventricular rate less than 50 beats\u002Fmin)\n* Known allergy\u002Fsensitivity (\\>= grade 3) to nemtabrutinib or any of the excipients.\n\n  * NOTE: Refer to the investigator brochure (IB) for details regarding excipients for nemtabrutinib\n* History of severe bleeding disorders\n* A POCBP who has a positive urine pregnancy test within 72 hours prior to enrollment. If the urine test is positive or cannot be confirmed as negative, a serum pregnancy test will be required\n\n  * Note: in the event that 72 hours have elapsed between the screening pregnancy test and the first dose of study treatment, another pregnancy test (urine or serum) must be performed and must be negative in order for subject to start receiving study medication\n* Prior CLL\u002FSLL directed therapy\n* Currently being treated with the following drugs:\n\n  * P-glycoprotein (P-gp) substrates with a narrow therapeutic index\n  * CYP3A strong inducers\n  * CYP3A strong inhibitors\n  * NOTE: A washout period of at least 5 times the half-life after the last dose of any of the above treatments is required for a participant to be eligible for study enrollment. A list of example in vivo substrates for specific CYP enzymes and P-gp is provided\n  * NOTE: Refer to protocol regarding prohibited concomitant medications and potential drug interactions after participant randomization\n* Has received prior systemic anti-cancer therapy including investigational agents within 4 weeks (if prior therapy was a monoclonal antibody) or 5 half-lives before randomization (whichever is longer)\n* Has received prior radiotherapy within 2 weeks of start of study intervention or radiation-related toxicities requiring corticosteroids\n\n  * Note: Two weeks or fewer of palliative radiotherapy for non-CNS disease, with a 1-week washout, is permitted\n* Has received a live vaccine or live-attenuated vaccine within 30 days before the first dose of study intervention. Administration of killed vaccines are allowed.\n\n  * Note: please refer to protocol for information on COVID-19 vaccines\n* Is currently enrolled on another therapeutic clinical trial. Concurrent enrollment on another therapeutic clinical trial or any trial designed to impact the efficacy of anti-cancer therapy is prohibited\n* Diagnosis of immunodeficiency or is receiving chronic systemic steroid therapy (in dosing exceeding 10 mg daily of prednisone equivalent) or any other form of immunosuppressive therapy within 7 days prior the first dose of study medication\n* Has active autoimmune disease that has required systemic treatment in the past 2 years except replacement therapy (e.g., thyroxine, insulin, or physiologic corticosteroid)\n* Has an active infection requiring systemic therapy\n* Has not adequately recovered after 4 weeks from major surgery or has ongoing surgical complications.\n\n  * Note: Biopsy and placement of central venous access devices are not considered major surgery\n* Has known psychiatric or substance abuse disorders that would interfere with cooperation with the requirements of the trial",{"count":7,"type":21},[217],"PHASE2","This phase II trial tests how well nemtabrutinib and venetoclax work in treating patients with chronic lymphocytic leukemia (CLL) or small lymphocytic lymphoma (SLL). Nemtabrutinib is in a class of medications called kinase inhibitors. It blocks a protein called BTK, which is present on B-cells (a type of white blood cell) in cancers such as CLL or SLL at abnormal levels. This may help keep cancer cells from growing and spreading. Venetoclax is in a class of medications called B-cell lymphoma-2 (BCL-2) inhibitors. It may stop the growth of cancer cells by blocking BCL-2, a protein needed for cancer cell survival. Giving nemtabrutinib in combination with venetoclax may kill more cancer cells in patients with CLL or SLL.",[25,168],"NOT_YET_RECRUITING","2026-06-29",{"date":62,"type":37},{"date":224,"type":21},"2026-09-01",{"date":226,"type":21},"2027-12-31",{"name":228,"class":71},"Jennifer Woyach",{"id":230,"slug":231,"hasResults":12,"nctId":232,"briefTitle":233,"officialTitle":233,"acronym":4,"eligibilityCriteria":234,"healthyVolunteers":12,"sex":18,"minAge":162,"maxAge":4,"enrollmentInfo":235,"targetDuration":4,"studyType":56,"phases":237,"briefSummary":239,"conditions":240,"keywords":248,"overallStatus":33,"whyStopped":4,"lastUpdateSubmitDate":221,"lastUpdatePostDateStruct":251,"startDateStruct":252,"completionDateStruct":254,"leadSponsor":255,"locationsCount":45},"100582251","combating-cancer-related-fatigue-a-personalized-supportive-care-program-100582251","NCT06860880","Combating Cancer-Related Fatigue: A Personalized Supportive Care Program","In order to participate in this study a subject must meet all of the eligibility criteria outlined below.\n\nInclusion Criteria:\n\n* Written informed consent was obtained to participate in the study and HIPAA authorization for the release of personal health information.\n* Subjects are willing and able to comply with study procedures based on the judgment of the investigator.\n* Age ≥ 18 years at the time of consent.\n* Confirmed diagnosis of indolent lymphoma, Waldenström's Macroglobulinemia, or Cutaneous T Cell Lymphoma.\n* Significant symptoms of fatigue, as defined by PROMIS Fatigue score \\>50.\n\nExclusion Criteria:\n\n* Other co-existing malignancies.\n* Significant cognitive impairment as defined by Mini-Cog score 0-2 (out of 5) that would prevent understanding of assessments or interventions.\n* Unstable or serious illness (e.g., unstable cardiac arrhythmia, severe anemia\u002Fthrombocytopenia) that would prevent safe participation in an exercise regimen, per the discretion of the treating physician.\n* Individuals who are not able to consume an oral diet, due to swallowing difficulties or other reasons, as this might interfere with the nutritional intervention",{"count":236,"type":21},40,[238],"NA","This health services study will assess a multidisciplinary intervention program directed at fatigue mitigation among patients diagnosed with indolent lymphomas. Specifically, 30 subjects with chronic lymphocytic leukemia\u002Fsmall lymphocytic lymphoma (CLL\u002FSLL) and 10 subjects with Follicular Lymphoma (FL), marginal zone lymphoma (MZL), lymphoplasmacytic lymphoma (LPL), Waldenström's Macroglobulinemia, or Cutaneous T Cell Lymphoma (CTCL) will be included.",[241,242,25,168,243,244,245,246,247],"Indolent Lymphomas","Lymphoma","Follicular Lymphoma","Marginal Zone Lymphoma","Lymphoplasmacytic Lymphoma","Waldenstrom Macroglobulinemia","Cutaneous T Cell Lymphoma",[249,250],"exercise","dietary intervention",{"date":62,"type":37},{"date":253,"type":37},"2025-06-03",{"date":41,"type":21},{"name":256,"class":71},"UNC Lineberger Comprehensive Cancer Center",{"id":258,"slug":259,"hasResults":12,"nctId":260,"briefTitle":261,"officialTitle":261,"acronym":4,"eligibilityCriteria":262,"healthyVolunteers":12,"sex":18,"minAge":162,"maxAge":4,"enrollmentInfo":263,"targetDuration":4,"studyType":56,"phases":264,"briefSummary":265,"conditions":266,"keywords":4,"overallStatus":220,"whyStopped":4,"lastUpdateSubmitDate":267,"lastUpdatePostDateStruct":268,"startDateStruct":269,"completionDateStruct":270,"leadSponsor":272,"locationsCount":45},"100644871","phase-2-a-phase-2-trial-of-the-combination-of-zanubrutinib-sonrotoclax-and-obinutuzumab-for-patients-with-treatment-nave-chronic-lymphocytic-leukemia-100644871","NCT07674810","A Phase 2 Trial Of The Combination Of Zanubrutinib, Sonrotoclax, And Obinutuzumab For Patients With Treatment-Naïve Chronic Lymphocytic Leukemia","Inclusion Criteria:\n\n1. Patients with a diagnosis of previously untreated CLL\u002FSLL meeting iwCLL 2018 indication for treatment (Note: patients who receive steroids and\u002For CD20 mAb for cytoreduction in those patients presenting with significantly elevated WBC count or significant adenopathy\u002Forganomegaly and those who previously received steroids\u002FCD20 mAb for immune cytopenias are eligible to enroll; Washout of 3 months applies for CD20 mAb and dose of prednisone (or equivalent) should be less than 20 mg\u002Fday by day 1 of study initiation)\n2. Age greater than or equal to 18 years of age\n3. Eastern Cooperative Oncology Group (ECOG) Performance status of 0-2\n4. Adequate hepatic function a. Total bilirubin ≤1.5 x upper limit of normal (ULN) or ≤3 x ULN for patients with Gilbert's disease or documented disease involvement of liver (In pts with elevated total bilirubin due to increased indirect bilirubin, pts with direct bilirubin ≤1.5 x ULN are eligible) b. ALT and AST ≤3.0 x ULN, or ≤5.0 x ULN if documented disease involvement of liver\n5. Adequate renal function a. Adequate renal function defined by a value ≥30 mL\u002Fmin determined via estimated GFR calculated according to the CKD-EPI equation\n6. Adequate hematologic function\n\n   a. Platelet count ≥50 x109 \u002FL and hemoglobin ≥8 g\u002FdL (≥80 g\u002FL). Platelet and hemoglobin requirements are independent of transfusions within 7 days of screening assessment and first dose of study drugs.\n\n   b. Absolute neutrophil count ≥0.75 x 109 \u002FL. Absolute neutrophil count is independent of growth factor support within 7 days of screening assessment and first dose of study drugs.\n7. Adequate coagulation function a. INR ≤1.5 x ULN and aPTT ≤1.5 x ULN\n8. Ability to swallow tablets and comply with outpatient treatment, laboratory monitoring, and required clinic visit for the duration of study participation\n9. Women of childbearing potential must have a negative serum or urine beta human chorionic gonadotropin (β-hCG) pregnancy test result within 24 hours prior to the first dose of study drugs and must agree to use an effective contraception method (combined hormonal contraception, progestogenonly hormonal contraception associated with inhibition of ovulation, intrauterine devices, intrauterine hormone-releasing systems, bilateral tubal occlusion, or vasectomized partners) during the study and for at least 18 months following the last dose of study drug. Women of non-childbearing potential are those who are postmenopausal greater than 2 year or who have had a bilateral tubal ligation or hysterectomy. Men who have partners of childbearing potential must agree to use an effective contraceptive method (condom or vasectomy) during the study and for at least 18 months following the last dose of study drug. Egg and sperm donation should be refrained for at least 18 months from the last dose of study drug, respectively.\n\nExclusion Criteria:\n\n1\\. Major surgery within 4 weeks prior to the first dose of study drugs 2. Uncontrolled active systemic infection 3. Known positive serology for human immunodeficiency virus (HIV) 4. Active hepatitis B infection (defined as the presence of detectable HBV DNA, HBe antigen or HBs antigen). Patients with serologic evidence of prior vaccination (HBsAg negative, anti-HBs antibody positive, anti-HBc antibody negative) are eligible. Patients who are HBsAg negative\u002FHBsAb positive but HBcAb positive are eligible, provided HBV DNA is negative and they are willing to take appropriate antiviral prophylaxis 5. Active hepatitis C infection (defined as detectable hepatitis C RNA in plasma by PCR) 6. Known active cytomegalovirus (CMV) infection. Unknown or negative status are eligible 7. Active, uncontrolled autoimmune phenomenon (autoimmune hemolytic anemia or immune thrombocytopenia) requiring steroid therapy with \\>20 mg daily of prednisone or equivalent 8. Clinically significant, uncontrolled cardiovascular disease (≥3 NYHA heart failure, uncontrolled or symptomatic arrhythmias), or myocardial infarction within 6 months, or stroke within 6 months, or intracranial bleeding within 6 months prior to start of study drugs 9. Uncontrolled hypertension defined as 2 consecutive systolic blood pressure ≥160 mmHg and \u002For diastolic blood pressure ≥100 mmHg within 3 months 10. History of Mobitz II second degree or third-degree heart block without a permanent pacemaker in place 11. Prolongation of the QT interval corrected for heart rate (QTcF) \\>480 msec. Note: Patients with QTcF \\>480 msec should have EKG repeated. If QTcF again is \\>480 msec, then the patient should be referred to cardiology for evaluation. Patients can be enrolled later if cleared by cardiology and repeat QTcF less than 480 msec. QTcF is calculated using Fridericia's Formula (QTcF): QTcF = QT\u002F(RR0.33)\n\n1. Correction of suspected drug-induced QTcF prolongation can be attempted at the investigator's discretion and only if clinically safe to do so with either discontinuation of the offending drug or switch to another drug not known to be associated with QTcF prolongation.\n2. Correction for underlying bundle branch block (BBB) allowed. Note: Patients with pacemakers are eligible if they have no history of fainting or clinically relevant arrhythmias while using the pacemaker 12. Pregnancy, lactation or plan to breastfeed during the study or within 6 months of the last dose of study treatment 13. Concurrent use of warfarin or another vitamin K antagonist 14. Receiving treatment with a strong CYP3A inhibitor or strong CYP3A inducer ≤14 days or 5 half-lives, whichever is longer, before the first dose of study treatment(s) OR requiring long-term use of strong CYP3A inhibitors or inducers.\n\n   15\\. Patients consumed grapefruit, grapefruit products, Seville oranges (including marmalade containing Seville oranges) or Starfruit within 3 days prior to the initiation of study treatment 16. Known central nervous system involvement by CLL\u002FSLL 17. Active second malignancy unless in remission and with life expectancy \\>2 years with exception of patients diagnosed with basal cell or squamous cell carcinoma of the skin or carcinoma \"in situ\" of the cervix or breast who are eligible even if diagnosed within 2 years. If patients have another malignancy that was treated within the last 2 years, such patients may be enrolled, if the likelihood of requiring systemic therapy for this other malignancy within 2 years is less than 10%, as determined by an expert in that particular malignancy at MD Anderson Cancer Center, and after consultation with the Principal Investigator. 18. Known hypersensitivity to any component or excipient of study drugs 19. Malabsorption syndrome or other condition likely to affect gastrointestinal absorption of the study drugs 20. Receipt of live-virus vaccines within 4 weeks prior to starting study drugs 21. History of bleeding diathesis and\u002For history of known bleeding disorder including hemophilia A, hemophilia B, von Willebrand disease, or history of spontaneous bleeding requiring blood transfusion or other medical intervention 22. Known prolymphocytic leukemia or history of, or currently suspected, Richter transformation (biopsy based on clinical suspicion may be needed to rule our transformation)",{"count":236,"type":21},[217],"The goal of this clinical research study is to learn if the combination of zanubrutinib, sonrotoclax, and obinutuzumab can help to control previously untreated CLL\u002FSLL.",[25],"2026-06-26",{"date":200,"type":37},{"date":41,"type":21},{"date":271,"type":21},"2029-04-30",{"name":273,"class":71},"M.D. Anderson Cancer Center",{"id":275,"slug":276,"hasResults":12,"nctId":277,"briefTitle":278,"officialTitle":279,"acronym":4,"eligibilityCriteria":280,"healthyVolunteers":12,"sex":18,"minAge":162,"maxAge":82,"enrollmentInfo":281,"targetDuration":4,"studyType":56,"phases":283,"briefSummary":284,"conditions":285,"keywords":288,"overallStatus":220,"whyStopped":4,"lastUpdateSubmitDate":290,"lastUpdatePostDateStruct":291,"startDateStruct":292,"completionDateStruct":294,"leadSponsor":296,"locationsCount":45},"100645065","phase-1-baff-car-t-cells-lmy-922-for-treatment-of-refractory-hematologic-malignancies-100645065","NCT07679919","BAFF CAR-T Cells (LMY-922) for Treatment of Refractory Hematologic Malignancies","A Phase 1 Study of Allogeneic (γ\u002Fδ) BAFF CAR-T Cells (LMY-922) for Treatment of Refractory Hematologic Malignancies","Inclusion Criteria:\n\n1\\. Male or female 18-75 years of age. 2. Patient with:\n\na. NHL: Histologically confirmed B cell NHL (including but not limited to diffuse large B cell lymphoma (DLBCL), follicular lymphoma, MCL, marginal zone lymphoma (MZL)) i. Relapsed after 2 or more lines of therapy, or ii. Have disease refractory to prior chemotherapy (defined as progressive disease or stable disease lasting ≤ 6 months, as best response to most recent chemotherapy regimen; or disease progression, or recurrence ≤ 12 months after prior autologous stem cell transplantation (ASCT), and iii. Measurable disease per Lugano Revised Response Criteria for Malignant Lymphoma\n\nor\n\nb. CLL: histologically confirmed CLL i. Relapsed after 2 or more lines of therapy ii. Previous therapies prescribed must have included a Bruton's tyrosine kinase (BTK) inhibitor and a B-cell lymphoma 2 (BCL2) inhibitor, iii. Measurable disease and active disease: Active disease as defined by the iwCLL criteria, meeting at least one of the following criteria:\n\n1. Evidence of progressive marrow failure as manifested by the development of, or worsening of, anemia and\u002For thrombocytopenia. Cutoff levels of Hb \\\u003C10 g\u002FdL or platelet counts \\\u003C100 × 10\\^9\u002FL are generally regarded as indication for treatment.\n2. Massive (i.e., ≥6 cm below the left costal margin) or progressive or symptomatic splenomegaly.\n3. Massive nodes (i.e., ≥10 cm in longest diameter) or progressive or symptomatic lymphadenopathy.\n4. Symptomatic or functional extranodal involvement (e.g., skin, kidney, lung, spine, etc.).\n5. Disease-related symptoms as defined by any of the following:\n\n   1. Unintentional weight loss ≥10% within the previous 6 months.\n   2. Significant fatigue (i.e., Eastern Cooperative Oncology Group (ECOG) performance scale 2 or worse; cannot work or unable to perform usual activities).\n   3. Fevers ≥ 38.0°C for 2 or more weeks without evidence of infection.\n   4. Night sweats for ≥1 month without evidence of infection.\n\nor\n\nc. HCL: histologically confirmed HCL i. Relapsed after at least one line of therapy, which must have included a purine nucleoside (eg. fludarabine, cladribine or pentostatin) and moxetumomab pasudotox.\n\nii. Need for treatment as evidenced by any one of the following: Absolute Neutrophil Count (ANC) \\\u003C1 × 10\\^3\u002FmcL, Hb \\\u003C10g\u002FdL, platelet count \\\u003C100 × 10\\^3\u002FmcL, leukemia cell count \\>5 × 10\\^3\u002FmcL, symptomatic splenomegaly, or enlarging HCL mass \\>2 cm in short axis.\n\nor\n\nd. MM: histologically confirmed MM i. Relapsed or refractory after 3 or more lines of therapy including an immunomodulatory agent, a proteasome inhibitor and an anti-CD38 antibody.\n\nii. Measurable disease per IMWG uniform response criteria 3. Adequate organ function as defined by:\n\n1. Creatinine clearance more than or equal to 45 ml\u002Fmin calculated by the Cockcroft - Gault formula\n2. Subjects must have adequate cardiac function as defined as left ventricular ejection fraction ≥ 45% on the most recent echocardiogram and no clinically significant arrhythmias, pericardial effusion, valvular, or ischemic heart disease.\n3. Adequate pulmonary function with pulse oximetry ≥ 92% on room air.\n4. Total Bilirubin \\\u003C 1.5× the institutional upper limit of normal (\\\u003C2.5× if caused by the baseline cancer and in patients with Gilbert's syndrome).\n5. Alanine aminotransferase (ALT (Serum Glutamic-Pyruvic Transaminase (SGPT))) and Aspartate Aminotransferase (AST (Serum Glutamic-Oxaloacetic Transaminase (SGOT) \\\u003C 2.5× the institutional upper limit of normal.\n\n   4\\. Subjects (or legal guardians) must have the ability to understand and the willingness to sign a written informed consent document.\n\n   5\\. For women of childbearing potential: agreement to remain abstinent (refrain from heterosexual intercourse) or use a contraceptive method with a failure rate of \\\u003C 1% per year during the treatment period and for at least 1 year after CAR-T cell infusion.\n\nA woman is considered to be of childbearing potential if she is postmenarcheal, has not reached a postmenopausal state (\\\u003C 12 continuous months of amenorrhea with no identified cause other than menopause), and has not undergone surgical sterilization (removal of ovaries and\u002For uterus).\n\nExamples of contraceptive methods with a failure rate of \\\u003C 1% per year include bilateral tubal ligation, male sterilization, hormonal contraceptives that inhibit ovulation, hormone-releasing intrauterine devices, and copper intrauterine devices.\n\nThe reliability of sexual abstinence should be evaluated in relation to the duration\n\nof the clinical trial and the preferred and usual lifestyle of the patient. Periodic abstinence (e.g., calendar, ovulation, symptothermal, or postovulation methods) and withdrawal are not acceptable methods of contraception.\n\n6\\. For men: agreement to remain abstinent (refrain from heterosexual intercourse) or use contraceptive measures, and agreement to refrain from donating sperm, as defined below: With female partners of childbearing potential, men must remain abstinent or use a condom plus an additional contraceptive method that together result in a failure rate of \\\u003C 1% per year during the treatment period and for at least 1 year after CAR-T cell infusion. Men must refrain from donating sperm during this same period. With pregnant female partners, men must remain abstinent or use a condom during the treatment period and for at least 1 year after CAR-T cell infusion to avoid potential embryonal or fetal exposure.\n\nThe reliability of sexual abstinence should be evaluated in relation to the duration of the clinical trial and the preferred and usual lifestyle of the patient. Periodic abstinence (e.g., calendar, ovulation, symptothermal, or postovulation methods) and withdrawal are not acceptable methods of contraception.\n\n7\\. Body weight of at least 55kg for patients treated at dose level 3 (450 × million BAFF+ CAR cells) and at least 37kg for all other dose levels.\n\nExclusion Criteria:\n\n1. Second active (i.e., currently requires antineoplastic therapy) non-B cell lineage malignancy, other than non-melanoma skin cancer or carcinoma in situ (e.g. cervix, bladder, breast).\n2. Renal failure requiring regular dialysis.\n3. Uncontrolled pulmonary disease or infection.\n4. Cardiovascular disorders including symptomatic congestive heart failure, unstable angina pectoris, clinically significant cardiac arrhythmias, myocardial infarction or stroke (including transient ischemic attack, or other ischemic event) within 6 months prior to registration.\n5. Active infection requiring systemic treatment.\n6. HIV seropositive with a history of acquired immunodeficiency syndrome (AIDS)-defining opportunistic infections within 12 months of enrollment, or has not been on an established antiretroviral therapy (ART) for at least four weeks with an HIV viral load less than 400 copies\u002FmL.\n7. Pregnant or breastfeeding women are excluded from this study (breastfeeding should be discontinued), because there is an unknown, but potential risk for adverse events in fetuses and nursing infants secondary to treatment of the mother with LMY-922 and lymphodepleting chemotherapy. Women of childbearing potential must have a negative serum pregnancy test.\n8. Serologic status reflecting active hepatitis B or C infection. Patients that are positive for hepatitis B core antibody, hepatitis B surface antigen (HBsAg), or hepatitis C antibody must have a negative polymerase chain reaction (PCR) prior to enrollment. (PCR positive patients will be excluded.)\n9. Patients with history of clinically relevant central nervous system (CNS) pathology such as uncontrolled epilepsy, paresis, aphasia, uncontrolled cerebrovascular disease, severe brain injuries, dementia, and Parkinson's disease.\n10. Subjects with uncontrolled intercurrent or psychiatric illness\u002Fsocial situations that would limit compliance with study requirements.\n11. Patients receiving a live vaccine within 2 weeks prior to screening.\n12. Concurrent use of high dose systemic steroids and\u002For immunosuppressive therapies.\n\n    1. Steroid dose must be weaned to ≤10 mg\u002Fday prednisone equivalent prior to CAR-T cell infusion.\n    2. Immunosuppressive medications must be stopped at least 5 half-lives prior to CAR-T cell infusion.",{"count":282,"type":21},27,[188],"Therapy with chimeric antigen receptor T (CAR-T) cells has demonstrated activity against refractory hematologic malignancies, however not all tumors respond or remain in response to CD19 targeted CAR-T cells. We posit that CAR-T cells expressing BAFF (BAFF CAR-T cells) can become another strategy to treat refractory hematologic malignancies, even after relapse following cluster of differentiation antigen 19 (CD19) targeting CAR-T treatment. This phase 1 study will evaluate safe dose and provide initial signal of the activity of BAFF CAR-T cells against refractory hematologic malignancies using a single lymphodepletion regimen and using a BAFF CAR-T cell manufacturing process.",[199,25,286,287],"Hairy Cell Leukemia","Multiple Myeloma",[242,289],"B-cell","2026-06-25",{"date":62,"type":37},{"date":293,"type":21},"2026-09",{"date":295,"type":21},"2029-04",{"name":297,"class":44},"Luminary Therapeutics",{"id":299,"slug":300,"hasResults":12,"nctId":301,"briefTitle":302,"officialTitle":303,"acronym":4,"eligibilityCriteria":304,"healthyVolunteers":12,"sex":18,"minAge":162,"maxAge":4,"enrollmentInfo":305,"targetDuration":4,"studyType":56,"phases":307,"briefSummary":308,"conditions":309,"keywords":4,"overallStatus":33,"whyStopped":4,"lastUpdateSubmitDate":290,"lastUpdatePostDateStruct":310,"startDateStruct":311,"completionDateStruct":313,"leadSponsor":315,"locationsCount":317},"100526578","phase-3-a-study-of-nemtabrutinib-mk-1026-versus-comparator-investigators-choice-of-ibrutinib-or-acalabrutinib-in-first-line-1l-chronic-lymphocytic-leukemia-cll-small-lymphocytic-lymphoma-sll-mk-1026-011bellwave-011-100526578","NCT06136559","A Study of Nemtabrutinib (MK-1026) Versus Comparator (Investigator's Choice of Ibrutinib or Acalabrutinib) in First Line (1L) Chronic Lymphocytic Leukemia (CLL)\u002F Small Lymphocytic Lymphoma (SLL) (MK-1026-011\u002FBELLWAVE-011)","A Phase 3, Randomized Study to Compare Nemtabrutinib Versus Comparator (Investigator's Choice of Ibrutinib or Acalabrutinib) in Participants With Untreated Chronic Lymphocytic Leukemia\u002FSmall Lymphocytic Lymphoma (BELLWAVE-011)","Inclusion Criteria:\n\nThe main inclusion criteria include but are not limited to the following:\n\n* Confirmed diagnosis of CLL\u002FSLL and active disease clearly documented to have a need to initiate therapy.\n* Has at least 1 marker of disease burden.\n* Has an Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 2 within 7 days before randomization.\n* Has the ability to swallow and retain oral medication.\n* Participants who are hepatitis B surface antigen (HBsAg) positive are eligible if they have received hepatitis B virus (HBV) antiviral therapy for at least 4 weeks and have undetectable HBV deoxyribonucleic acid (DNA) viral load before randomization.\n* Participants with history of hepatitis C virus (HCV) infection are eligible if HCV ribonucleic acid (RNA) viral load is undetectable at screening.\n* Participants with human immunodeficiency virus (HIV) who meet ALL eligibility criteria.\n\nExclusion Criteria:\n\nThe main exclusion criteria include but are not limited to the following:\n\n* Has an active hepatitis B virus\u002F hepatitis C virus (HBV\u002FHCV) infection.\n* Has gastrointestinal (GI) dysfunction that may affect drug absorption.\n* Has diagnosis of Richter Transformation or active central nervous system (CNS) involvement by CLL\u002FSLL.\n* Has had acquired immune deficiency syndrome (AIDS)-defining opportunistic infection in the past 12 months before screening.\n* Has clinically significant cardiovascular disease.\n* Has hypersensitivity to nemtabrutinib or contraindication to ibrutinib or acalabrutinib, or any of the excipients.\n* Has history of severe bleeding disorder.\n* Has known additional malignancy that is progressing or has required active treatment within the past 2 years.\n* Has received any systemic anticancer therapy for CLL\u002FSLL.\n* Is currently being treated with p-glycoprotein (P-gp) substrates with a narrow therapeutic index, cytochrome P450 3A (CYP3A) strong or moderate inducers or CYP3A strong inhibitors.\n* Received prior radiotherapy within 2 weeks of start of study intervention, or radiation-related toxicities, requiring corticosteroids.\n* Received a live or live-attenuated vaccine within 30 days before the first dose of study intervention. Administration of killed vaccines are allowed.\n* Has received an investigational agent or has used an investigational device within 4 weeks before study intervention administration.\n* Has active infection requiring systemic therapy, including intravenous (IV) antibiotics during screening.\n* Participants who have not adequately recovered from major surgery or have ongoing surgical complications.",{"count":306,"type":21},1200,[58],"The goal of this study is to evaluate nemtabrutinib compared with investigator's choice of ibrutinib or acalabrutinib in participants with chronic lymphocytic leukemia (CLL)\u002Fsmall lymphocytic lymphoma (SLL) who have not received any prior therapy. The primary hypotheses are that (1) nemtabrutinib is non-inferior to ibrutinib or acalabrutinib with respect to objective response rate (ORR) per International Workshop on Chronic Lymphocytic Leukemia (iwCLL) Criteria 2018 by blinded independent central review (BICR) and (2) nemtabrutinib is superior to ibrutinib or acalabrutinib with respect to progression free survival (PFS) per iwCLL Criteria 2018 by BICR.",[25,168],{"date":267,"type":37},{"date":312,"type":37},"2023-12-13",{"date":314,"type":21},"2032-09-07",{"name":316,"class":44},"Merck Sharp & Dohme LLC",199,{"id":319,"slug":320,"hasResults":12,"nctId":321,"briefTitle":322,"officialTitle":323,"acronym":4,"eligibilityCriteria":324,"healthyVolunteers":12,"sex":18,"minAge":162,"maxAge":4,"enrollmentInfo":325,"targetDuration":4,"studyType":56,"phases":327,"briefSummary":328,"conditions":329,"keywords":330,"overallStatus":33,"whyStopped":4,"lastUpdateSubmitDate":334,"lastUpdatePostDateStruct":335,"startDateStruct":336,"completionDateStruct":338,"leadSponsor":340,"locationsCount":342},"100557951","phase-2-zanubrutinib-with-obinutuzumab-in-untreated-patients-with-chronic-lymphocytic-leukemia-or-small-lymphocytic-lymphoma-100557951","NCT06544785","Zanubrutinib With Obinutuzumab in Untreated Patients With Chronic Lymphocytic Leukemia or Small Lymphocytic Lymphoma","A Multicenter, Phase 2 Randomized, Open Label Study to Evaluate Zanubrutinib in Combination With Obinutuzumab in Previously Untreated Patients With Chronic Lymphocytic Leukemia (CLL) or Small Lymphocytic Lymphoma (SLL) (GELLC-10-ZANUBIO)","Inclusion Criteria:\n\n1. Adult patients with previously untreated CLL defined following IWCLL criteria (Hallek, 2018).\n2. Must understand and voluntarily sign an informed consent form.\n3. Age ≥ 18 years at the time of signing the informed consent form and must be able to adhere to the study visit schedule and other protocol requirements.\n4. Must have a documented diagnosis of CLL or SLL \\[IWCLL guidelines for diagnosis and treatment of CLL (Hallek, 2018)\\] meeting at least one of the following criteria:\n\n   * Evidence of progressive marrow failure as manifested by the development of, or worsening of, anemia and\u002For thrombocytopenia.\n   * Massive (i.e. ≥6 cm below the left costal margin) or progressive or symptomatic splenomegaly.\n   * Massive nodes (i.e. ≥10 cm in longest diameter) or progressive or symptomatic lymphadenopathy.\n   * Progressive lymphocytosis with an increase of ≥50% over a 2-month period, or lymphocyte doubling time (LDT) of less than 6 months.\n   * A minimum of any one of the following disease-related symptoms: unintentional weight loss ≥ 10% within the previous 6 months, significant fatigue (i.e., ECOG PS 2 or worse; cannot work or unable to perform usual activities), fevers of greater than 38.0°C for 2 or more weeks without other evidence of infection, or night sweats for more than 1 month without evidence of infection.\n   * Autoimmune complications including anemia or thrombocytopenia poorly responsive to corticosteroids.\n   * Symptomatic or functional extranodal involvement (eg, skin, kidney, lung, spine).\n5. Must have an Eastern Cooperative Oncology Group (ECOG) performance status score of ≤2.\n6. Female patients of childbearing potential must practice highly effective methods of contraception initiated prior to first dose of study drug, for the duration of the study, and for ≥ 90 days after the last dose of zanubrutinib and 18 months after last dose of obinutuzumab.\n\n   Male patients are eligible if vasectomized or if they agree to the use of barrier contraception with other applicable highly effective methods described below during the study treatment period and for ≥ 90 days after the last dose of zanubrutinib and 18 months after last dose of obinutuzumab.\n\n   A woman is considered of childbearing potential, ie, fertile, following menarche and until becoming postmenopausal unless permanently sterile. Permanent sterilization methods include hysterectomy, bilateral salpingectomy, and bilateral oophorectomy. Contraception methods include the following:\n   * Combined (estrogen- and progestogen- containing) hormonal contraception associated with the inhibition of ovulation - Oral, intravaginal, or transdermal.\n   * Progestogen-only hormonal contraception associated with the inhibition of ovulation - Oral, injectable, implantable.\n   * An intrauterine device.\n   * Intrauterine hormone-releasing system.\n   * Bilateral tubal occlusion.\n   * Vasectomized partner (provided that the vasectomized partner is the sole sexual partner of the woman of childbearing potential study participant and that the vasectomized partner has received medical assessment of surgical success).\n   * Sexual abstinence (defined as refraining from heterosexual intercourse during the entire period of risk associated with the study treatment, starting the day prior to first dose of study drug, for the duration of the study, and for ≥ 90 days after the last dose of zanubrutinib or ibrutinib. Total sexual abstinence should only be used as a contraceptive method if it is in line with the patients' usual and preferred lifestyle. Periodic abstinence (eg, calendar, ovulation, symptothermal, post-ovulation methods), declaration of abstinence for the duration of exposure to investigational medicinal product, and withdrawal are not acceptable methods of contraception.\n\n   Of note, barrier contraception (including male and female condoms with or without spermicide) is not considered a highly effective method of contraception, and, if used, this method must be used in combination with another acceptable method listed above.\n\n   If patient is using hormonal contraceptives such as birth control pills or devices, a barrier method of contraception (eg, condoms) must also be used.\n\n   A postmenopausal state is defined as no menses for 12 months without an alternative medical cause. A high follicle-stimulating hormone level in the postmenopausal range may be used to confirm a postmenopausal state in women not using hormonal contraception or hormonal replacement therapy. However, in the absence of 12 months of amenorrhea, a single follicle-stimulating hormone measurement is insufficient.\n7. Female subjects of childbearing potential must have a negative pregnancy test at screening. Females of child bearing potential are defined as sexually mature women without prior hysterectomy or who have had any evidence of menses in the past 12 months. However, women who have been amenorrheic for 12 or more months are still considered to be of childbearing potential if the amenorrhea is possibly due to other causes, including prior chemotherapy, anti-estrogens, or ovarian suppression.\n\nExclusion Criteria:\n\n1. Prior treatment for CLL.\n2. Known Human Immunodeficiency Virus (HIV), Hepatitis B Virus (HBV) and\u002For Hepatitis C Virus (HCV) infection. Subjects who are hepatitis B core antibody (anti-HBc) positive and who are surface antigen negative could be eligible if they have an undetectable HBV DNA (negative polymerase chain reaction (PCR) \\\u003C20 IU). Those who are hepatitis B surface antigen (HbsAg) positive or hepatitis B PCR positive will be excluded. Subjects who are hepatitis C antibody positive will need to have a negative PCR result. Those who are hepatitis C PCR positive will be excluded.\n\n   Per published guidelines (NCCN 2012) or institutional guidelines, patients should be closely monitored for hepatitis B reactivation. Obtaining repeated hepatitis B PCR every 3 months during treatment and for the 12 months after last dose of study drug according to usual clinical practice in order to monitor for reactivation of hepatitis B is recommended.\n3. Estimated Glomerular Filtration Rate (Cockcroft-Gault Appendix C) ≤30 mL\u002Fmin\u002F1.73m2.\n4. Absolute neutrophil count (ANC) \\\u003C 1.0 X 109\u002FL.\n5. Platelet count \\\u003C 75 X 109\u002FL, except for patients with bone marrow involvement by CLL in which case the platelet count must be ≥ 30 X 109\u002FL.\n6. Serum aspartate aminotransferase (AST)\u002Fserum glutamic-oxaloacetic transaminase (SGOT) or alanine transaminase (ALT)\u002Fserum glutamate pyruvate transaminase (SGPT) \\>2.5 x upper limit of normal (ULN).\n7. Serum total bilirubin \\> 1.5 x ULN, except in cases of Gilbert's syndrome.\n8. Prothrombin time\u002FINR or aPTT (in the absence of Lupus anticoagulant) \\> 2x ULN.\n9. Active bleeding, history of bleeding diathesis (eg, haemophilia or von Willebrand disease).\n10. Unable to swallow capsules, or has disease significantly affecting gastrointestinal function that would limit absorption of oral medication.\n11. Currently active, clinically significant cardiovascular disease or a history of myocardial infarction within 3 months prior to enrollment. Exception: Subjects with controlled, asymptomatic atrial fibrillation during screening can enrol on study.\n12. Requires or receiving anticoagulation with warfarin or equivalent vitamin K antagonists (eg, phenprocoumon) within 7 days of first dose of study drug.\n13. Systemic infection that has not resolved prior to initiating study treatment in spite of adequate anti-infective therapy.\n14. Pregnant or lactating females.\n15. Participation in any clinical study or having taken any investigational therapy within 28 days prior to initiating study therapy.\n16. Central nervous system (CNS) involvement as documented by spinal fluid cytology or imaging.\n17. Prior history of malignancies, other than CLL, unless the patient has been free of the disease for ≥ 3 years.\n\n    Exceptions include the following:\n    * Basal cell carcinoma of the skin\n    * Squamous cell carcinoma of the skin\n    * Carcinoma in situ of the cervix\n    * Carcinoma in situ of the breast\n    * Incidental histologic finding of prostate cancer (TNM stage of T1a or T1b)\n18. Presence of autoimmune haemolytic anaemia or autoimmune thrombocytopenia.\n19. Major surgery within the last 28 days prior to registration.\n20. History of stroke or intracranial haemorrhage within 6 months prior to enrollment.\n21. Requires treatment with strong CYP3A4\u002F5 Inhibitors.\n22. Known history of drug-specific hypersensitivity or anaphylaxis to study drug (including active product or excipient components).\n23. Any life-threatening illness, medical condition, or organ system dysfunction which, in the Investigator's opinion, could compromise the subject's safety, interfere with the absorption or metabolism of zanubrutinib, or put the study outcomes at undue risk.",{"count":326,"type":21},106,[217],"The goal of this phase II randomized open label study is to compare the rate of complete remission (CR) with undetectable minimal residual disease (uMRD) obtained with zanubrutinib in combination with obinutuzumab with two different schedules of administration of obinutuzumab (starting obinutuzumab at cycle 2 or 12 months) in patients with previously untreated Chronic Lymphocytic Leukemia (CLL) or Small Lymphocytic Lymphoma (SLL). There is scarce information about which is the most appropriate schedule of combining the BTKi and the anti-CD20 monoclonal antibody, and whether treatment can be safely stopped in those patients attaining deep responses (CR with uMRD) remains to be determined.\n\nResponse will be assessed after 20 cycles of treatment for the primary objective of the study. Patients attaining uMRD will stop treatment with zanubrutinib, whereas the rest of patients will continue on treatment with zanubrutinib until progression, unacceptable toxicity, or trial completion, whichever comes first.",[25,168],[331,332,333],"zanubrutinib","obinutuzumab","untreated CLL\u002FSLL","2026-06-23",{"date":290,"type":37},{"date":337,"type":37},"2024-09-02",{"date":339,"type":21},"2032-05-31",{"name":341,"class":71},"PETHEMA Foundation",19,{"id":344,"slug":345,"hasResults":12,"nctId":346,"briefTitle":347,"officialTitle":348,"acronym":4,"eligibilityCriteria":349,"healthyVolunteers":12,"sex":18,"minAge":162,"maxAge":4,"enrollmentInfo":350,"targetDuration":4,"studyType":56,"phases":351,"briefSummary":352,"conditions":353,"keywords":4,"overallStatus":33,"whyStopped":4,"lastUpdateSubmitDate":334,"lastUpdatePostDateStruct":354,"startDateStruct":356,"completionDateStruct":358,"leadSponsor":360,"locationsCount":207},"100325407","phase-2-acalabrutinib-with-or-without-obinutuzumab-in-treating-patients-with-early-stage-chronic-lymphocytic-leukemia-or-small-lymphocytic-lymphoma-100325407","NCT03516617","Acalabrutinib With or Without Obinutuzumab in Treating Patients With Early-Stage Chronic Lymphocytic Leukemia or Small Lymphocytic Lymphoma","Randomized Phase 2 Study Comparing Acalabrutinib to Acalabrutinib and Obinutuzumab in the Treatment of Patients With Early-Stage Chronic Lymphocytic Leukemia\u002FSmall Lymphocytic Lymphoma (CLL\u002FSLL) Who Are at High Risk of Disease Progression","Inclusion Criteria:\n\n* Age \\>= 18 years\n* Diagnosis of:\n\n  * Biopsy-proven small lymphocytic lymphoma (SLL) , or\n  * Diagnosis of chronic lymphocytic leukemia (CLL) with a clonal B-cell population in the peripheral blood with immunophenotyping consistent with CLL as follows:\n\n    * The population of lymphocytes share both B-cell antigens (CD19, CD20 \\[typically dim expression\\], or CD23) as well as CD5 in the absence of other pan-T-cell markers (CD3, CD2, etc.)\n    * Clonality as evidenced by kappa or lambda light chain expression (typically dim immunoglobulin expression) or other genetic method (e.g. IGHV analysis)\n    * Before diagnosing CLL or SLL, mantle cell lymphoma must be excluded by demonstrating a negative fluorescence in situ hybridization (FISH) analysis for t(11;14)(IgH\u002FCCND1)\n* Patients must be previously untreated\n\n  * Note: Prior chemotherapy or monoclonal antibody based therapy for treatment of CLL or SLL will be considered prior therapy; nutraceutical treatments with no established benefit in CLL (such as epigallocatechin gallate or EGCG, found in green tea or other herbal treatments or supplemental vitamins) will not be considered \"prior treatment\"; prior corticosteroid therapy for an indication other than CLL\u002FSLL will not be considered \"prior treatment\"\n* All patients will undergo testing for prognostic factors according to the CLL-IPI (testing obtained =\\\u003C 730 days prior to registration)\n\n  * Note: If the results for any of the prognostic factors included in the CLL-IPI are unknown including IGVH mutation status results not being available due to a failed laboratory assay, the patient is not eligible\n  * Note: When determining CLL-IPI, use most recent test results, if more than one result is available\n  * Note: Patients with CLL-IPI risk category of high risk or very high risk (total score of 4-10) will be randomized to Arms A or B\n  * Note: Patients with CLL-IPI risk category of low risk or intermediate risk (total score of 0-3) will be registered to Arm C\n* Eastern Cooperative Oncology Group (ECOG) performance status (PS) 0, 1, or 2\n* Provide written informed consent\n* Willing to provide blood and saliva samples for correlative research purposes\n* Willing to return to enrolling institution for follow-up (during the active monitoring phase of the study)\n* For high risk and very high risk CLL-IPI (Arms A and B) only: Absolute neutrophil count (ANC) \\>= 1500\u002Fmm\\^3 (obtained =\\\u003C 30 days prior to randomization)\n* For high risk and very high risk CLL-IPI (Arms A and B) only: Platelet count \\>= 100,000\u002Fmm\\^3 (obtained =\\\u003C 30 days prior to randomization)\n* For high risk and very high risk CLL-IPI (Arms A and B) only: Hemoglobin \\>= 11.0 g\u002FdL (obtained =\\\u003C 30 days prior to randomization)\n* For high risk and very high risk CLL-IPI (Arms A and B) only: Aspartate aminotransferase (aspartate transaminase \\[AST\\]) =\\\u003C 3 x upper limit of normal (ULN) (obtained =\\\u003C 30 days prior to randomization)\n* For high risk and very high risk CLL-IPI (Arms A and B) only: Creatinine =\\\u003C 1.5 X ULN (obtained =\\\u003C 30 days prior to randomization)\n* For high risk and very high risk CLL-IPI (Arms A and B) only: Total bilirubin =\\\u003C 1.5 x upper limit of normal (ULN) (or total bilirubin =\\\u003C 3.0 x ULN with direct bilirubin =\\\u003C 1.5 x ULN in patients with well-documented Gilbert's syndrome (obtained =\\\u003C 30 days prior to randomization)\n* For high risk and very high risk CLL-IPI (Arms A and B) only: Prothrombin time (PT), international normalized ratio (INR), and partial thromboplastin time (PTT) =\\\u003C 1.5 X ULN OR if patient is receiving anticoagulant therapy and PT or PTT is within therapeutic range of intended use of coagulants (obtained =\\\u003C 30 days prior to randomization)\n* Negative serum pregnancy test done =\\\u003C 7 days prior to registration, for persons of childbearing potential only\n* Will provide bone marrow aspirate sample for correlative research purposes\n\nExclusion Criteria:\n\n* Date of CLL\u002FSLL diagnosis \\>= 24 months prior to registration\n* Prior exposure to ibrutinib or to a BCR inhibitor (e.g. Btk or PI3 kinase or Syk inhibitors) or a BCL-2 inhibitor (e.g. venetoclax)\n* Known central nervous system (CNS) lymphoma or leukemia\n* Patients with any of the following indications for chemotherapy:\n\n  * Evidence of progressive marrow failure as manifested by the development of or worsening anemia (=\\\u003C 11 g\u002FdL) and\u002For thrombocytopenia (=\\\u003C 100 x 10\\^9\u002FL) not due to autoimmune disease\n  * Symptomatic or progressive lymphadenopathy, splenomegaly or hepatomegaly\n  * One or more of the following disease-related symptoms:\n\n    * Weight loss \\>= 10% within the previous 6 months\n    * Extreme fatigue attributed to CLL\n    * Fevers \\>= 100.4 degrees Fahrenheit (F) for 2 weeks without evidence of infection\n    * Drenching night sweats without evidence of infection\n* Co-morbid systemic illnesses or other severe concurrent disease which, in the judgment of the investigator, would make the patient inappropriate for entry into this study or interfere significantly with the proper assessment of safety and toxicity of the prescribed regimens\n* Patients known to be human immunodeficiency virus (HIV) positive and currently receiving antiretroviral therapy; NOTE: Patients known to be HIV positive, but without clinical evidence of an immunocompromised state, are eligible for this trial\n* Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness\u002Fsocial situations that would limit compliance with study requirements\n* Receiving any other investigational agent which would be considered as a treatment for the primary neoplasm\n* Other active malignancy =\\\u003C 2 years prior to registration; EXCEPTIONS: Non-melanotic skin cancer, carcinoma-in-situ of the cervix, or early stage prostate cancer\n* History of myocardial infarction =\\\u003C 6 months prior to registration, or congestive heart failure requiring use of ongoing maintenance therapy for life-threatening ventricular arrhythmias\n* For high risk and very high risk CLL-IPI (Arms A and B) only:\n\n  * Any of the following:\n\n    * Pregnant persons\n    * Nursing persons\n    * Persons of childbearing potential who are unwilling to employ highly effective contraception\n  * Serologic status reflecting active hepatitis B or C infection\n\n    * NOTE: Subjects with hepatitis B core antibody positive who are surface antigen negative or who are hepatitis C antibody positive will need to have a negative polymerase chain reaction (PCR) result before randomization; those who are hepatitis B surface antigen positive or hepatitis B PCR positive and those who are hepatitis C PCR positive will be excluded\n  * History of stroke or intracranial hemorrhage within 6 months before randomization\n  * History of bleeding diathesis (e.g. hemophilia, von Willebrand disease)\n  * Requires or receiving anticoagulation with warfarin or equivalent vitamin K antagonists (e.g. phenprocoumon) within 7 days of first dose of study drug and while on study\n  * Requires treatment with a strong CYP3A inducer\n  * Presence of a gastrointestinal ulcer diagnosed by endoscopy within 3 months before screening\n  * History of confirmed progressive multifocal leukoencephalopathy (PML)\n  * Received a vaccination with a live vaccine =\\\u003C 28 days prior to randomization",{"count":20,"type":21},[217],"This phase II trials studies how well acalabrutinib with or without obinutuzumab works in treating patients with early-stage chronic lymphocytic leukemia or small lymphocytic lymphoma. Acalabrutinib may stop the growth of cancer cells by blocking some of the enzymes needed for cell growth. Immunotherapy with monoclonal antibodies, such as obinutuzumab, may help the body's immune system attack the cancer, and may interfere with the ability of tumor cells to grow and spread. It is not yet known whether giving acalabrutinib with or without obinutuzumab will work better in treating patients with early-stage chronic lymphocytic leukemia or small lymphocytic lymphoma.",[25,168],{"date":355,"type":37},"2026-06-24",{"date":357,"type":37},"2018-09-10",{"date":359,"type":21},"2030-10-16",{"name":361,"class":71},"Mayo Clinic",{"id":363,"slug":364,"hasResults":12,"nctId":365,"briefTitle":366,"officialTitle":367,"acronym":4,"eligibilityCriteria":368,"healthyVolunteers":12,"sex":18,"minAge":4,"maxAge":369,"enrollmentInfo":370,"targetDuration":4,"studyType":56,"phases":372,"briefSummary":373,"conditions":374,"keywords":393,"overallStatus":33,"whyStopped":4,"lastUpdateSubmitDate":334,"lastUpdatePostDateStruct":400,"startDateStruct":401,"completionDateStruct":403,"leadSponsor":405,"locationsCount":45},"100309946","phase-2-myeloablative-allo-hsct-with-related-or-unrelated-donor-for-heme-disorders-100309946","NCT03314974","Myeloablative Allo HSCT With Related or Unrelated Donor for Heme Disorders","Myeloablative Allogeneic Hematopoietic Cell Transplantation Using a Related or Unrelated Donor for the Treatment of Hematological Diseases","-Inclusion Criteria:\n\n* Age: ≤ 60 years of age\n* Performance Status: Karnofsky ≥ 70%, Lansky play score ≥ 70\n* Consent: Voluntary written consent (adult or legally authorized representative; or parental\u002Fguardian)\n* Adequate Organ Function:\n\n  * Renal: Creatinine \\\u003C2x upper limit of normal. Patients above this limit must have creatinine clearance ≥ 40 ml\u002Fmin\u002F1.73m2 as determined by an age-appropriate method, such as cystatin C GFR.\n  * Hepatic: Bilirubin, AST, alkaline phosphatase \\\u003C4 times the upper limit of institutional normal\n  * Pulmonary: Diffusion capacity of oxygen, corrected for hemoglobin, \\> 50% of predicted. For pediatric patients not able to undergo PFTs or diffusion testing: O2 sat of \\>95% on room air\n  * Cardiac: Absence of decompensated congestive heart failure, or uncontrolled arrhythmia and left ventricular ejection fraction \\> 45%. For children not able to cooperate with MUGA or echocardiography, such should be clearly stated in the physician's documentation\n  * HIV Status: HIV infection with undetectable viral load. All HIV+ patients must be evaluated by Infectious Disease (ID) and a HIV management plan establish prior to transplantation\n\nOther Inclusion Criteria:\n\n* Women of child bearing potential and sexually active males with partners of child bearing potential must agree to use adequate birth control for the duration of treatment.\n* Donor Availability: Patients considered for transplantation must have a sufficient graft as based on current criteria of the University of Minnesota Blood and Marrow Transplantation Program\n* Eligible Diseases and Status: Patients are eligible unless their treatment is to be guided by a higher priority protocol.\n* Acute Leukemias: Must be in remission by morphology (≤5% blasts). Also a small percentage of blasts that is equivocal between marrow regeneration vs. early relapse are acceptable provided there are no associated cytogenetic markers consistent with relapse.\n* Acute Myeloid Leukemia (AML) and related precursor neoplasms: 2nd or greater complete remission (CR); first complete remission (CR1) in patients \\> 60 years old; CR1 in ≤ 60 years old that is NOT considered as favorable-risk.\n* Favorable risk AML is defined as having one of the following:\n\n  * t(8,21) without cKIT mutation\n  * inv(16) or t(16;16) without cKIT mutation\n  * Normal karyotype with mutated NPM1 and wild type FLT-ITD\n  * Normal karyotype with double mutated CEBPA\n  * Acute prolymphocytic leukemia (APL) in first molecular remission at the end of consolidation\n* Very high risk pediatric patients with AML: Patients \\\u003C21 years, however, are eligible with (M2 marrow) with \\\u003C 25% blasts in marrow after having failed one or more cycles of chemotherapy.\n* Acute lymphoblastic leukemia (ALL)\u002Flymphoma: second or greater CR; CR1 unable to tolerate consolidation chemotherapy due to chemotherapy-related toxicities; CR1 high-risk ALL.\n* High risk ALL is defined as having one of the following:\n\n  * Evidence of high risk cytogenetics, e.g. t(9;22), t(1;19), t(4;11), other MLL rearrangements, IKZF1\n  * 30 years of age or older at diagnosis\n  * White blood cell counts of greater than 30,000\u002FmcL (B-ALL) or greater than 100,000\u002FmcL (T-ALL) at diagnosis\n  * CNS leukemia involvement during the course of disease\n  * Slow cytologic response (\\>10% lymphoblasts in bone marrow on Day 14 of induction therapy)\n  * Evidence of persistent immonophenotypic or molecular minimal residual disease (MRD) at the end of induction and consolidation therapy\n* Very high risk pediatric patients with ALL: patients \\\u003C21 years are also considered high risk CR1 if they had M2 or M3 marrow at day 42 from the initiation of induction or M3 marrow at the end of induction. They are eligible once they achieve a complete remission.\n* Chronic Myelogenous Leukemia excluding refractory blast crisis: To be eligible in first chronic phase (CP1) patient must have failed or be intolerant to one or more tyrosine kinase inhibitors.\n* Plasma Cell Leukemia after initial therapy, in patients who have achieved at least a partial remission\n* Myeloproliferative Neoplasms\u002FMyelofibrosis, either primary as a result of polycythemia vera or essential thrombocythemia, with disease risk of intermediate or high-risk according to DIPSS criteria. Blasts must be \\\u003C10% by bone marrow aspirate morphology.\n* Myelodysplasia (MDS) IPSS INT-2 or High Risk (i.e. RAEB, RAEBt) or Refractory Anemia with severe pancytopenia, transfusion dependence, or high risk cytogenetics or molecular features. Blasts must be \\\u003C 10% by a representative bone marrow aspirate morphology.\n* Chronic Lymphocytic Leukemia\u002FSmall Lymphocytic Lymphoma (CLL\u002FSLL), Marginal Zone B-Cell Lymphoma or Follicular Lymphoma are eligible if there was disease progression\u002Frelapse within 12 of achieving a partial or complete remission. Patients who had remissions lasting \\> 12 months, are eligible after at least two prior therapies. Patients with bulky disease (nodal mass greater than 5 cm) should be considered for debulking chemotherapy before transplant.\n* Lymphoplasmacytic Lymphoma, Mantle-Cell Lymphoma, Prolymphocytic Leukemia are eligible after initial therapy in CR1+ or PR1+.\n* Diffuse large Cell NHL \\> CR\u002F\\> PR: Patients in CR\u002FPR with initial short remission (\\\u003C6 months) are eligible, or those who have failed\u002For are not eligible for autologous transplant.\n* Lymphoblastic Lymphoma, Burkitt's Lymphoma, and other high-grade NHL after initial therapy if stage III\u002FIV in CR1\u002FPR1 or after progression if stage I\u002FII \\\u003C 1 year.\n* Multiple Myeloma beyond PR2: Patients with chromosome 13 abnormalities, first response lasting less than 6 months, or β-2 microglobulin \\> 3 mg\u002FL, may be considered for this protocol after initial therapy.\n* Juvenile myelomonocytic leukemia\n* Biphenotypic\u002FUndifferentiated\u002FProlymphocytic Leukemias in first or subsequent CR.\n* MRD positive leukemia (AML, ALL or accelerated\u002Fblast phase CML). Selected patients in morphologic CR, but with positive immunophenotypic (flow cytometry) or molecular evidence of MRD may be eligible if recent chemotherapy has not resulted in MRD negative status.\n* Natural Killer Cell Malignancies\n* Acquired Bone Marrow Failure Syndromes except for Fanconi Anemia or Dyskeratosis Congenita\n* Other Leukemia Subtypes: A major effort in the field of hematology is to identify patients who are of high risk for treatment failure so that patients can be appropriately stratified to either more (or less) intensive therapy. This effort is continually ongoing and retrospective studies identify new disease features or characteristics that are associated with treatment outcomes. Therefore, if new features are identified after the writing of this protocol, patients can be enrolled with the approval of two members of the study committee.\n\nExclusion Criteria:\n\n* Chemotherapy refractory large cell and high grade NHL (i.e., progressive disease after \\> 2 salvage regimens)\n* CML in blast crisis\n* Large cell lymphoma, mantle cell lymphoma and Hodgkin disease that is progressing on salvage therapy.\n* Evidence of progressive disease by imaging modalities or biopsy - persistent PET activity, though possibly related to lymphoma, is not an exclusion criterion in the absence of CT changes indicating progression.\n* Active central nervous system malignancy\n* if ≤ 18 years old, prior myeloablative transplant within the last 6 months. If \\>18 years old prior myeloablative allotransplant or autologous transplant\n* Active HIV infection or known HIV positive serology\n* active uncontrolled infection\n* Pregnant or breastfeeding. The agents used in this study include Pregnancy Category D: known to cause harm to a fetus. Females of childbearing potential must have a negative pregnancy test prior to starting therapy.","60 Years",{"count":371,"type":21},300,[217],"This is a Phase II study of allogeneic hematopoietic stem cell transplant (HCT) using a myeloablative preparative regimen (of either total body irradiation (TBI); or, fludarabine\u002Fbusulfan for patients unable to receive further radiation). followed by a post-transplant graft-versus-host disease (GVHD) prophylaxis regimen of post-transplant cyclophosphamide (PTCy), tacrolimus (Tac), and mycophenolate mofetil (MMF).",[375,88,87,242,376,377,378,197,379,380,381,25,168,382,243,245,383,384,385,195,386,387,287,388,389,390,391,392],"Acute Leukemia","Chronic Myelogenous Leukemia","Plasma Cell Leukemia","Myeloproliferative Neoplasms","Myelodysplasia","Refractory Anemia","High Risk Anemia","Marginal Zone B-Cell Lymphoma","Mantle-Cell Lymphoma","Prolymphocytic Leukemia","Diffuse Large Cell Non Hodgkins Lymphoma","Burkitt Lymphoma","High Grade Non-Hodgkin's Lymphoma, Adult","Juvenile Myelomonocytic Leukemia","Biphenotypic\u002FUndifferentiated\u002FProlymphocytic Leukemias","MRD Positive Leukemia","Natural Killer Cell Malignancies","Acquired Bone Marrow Failure Syndromes",[394,18,395,396,397,398,399],"AML","MDS","NHL","CLL","CML","SLL",{"date":290,"type":37},{"date":402,"type":37},"2018-03-30",{"date":404,"type":21},"2028-06-10",{"name":406,"class":71},"Masonic Cancer Center, University of Minnesota",{"id":408,"slug":409,"hasResults":12,"nctId":410,"briefTitle":411,"officialTitle":412,"acronym":4,"eligibilityCriteria":413,"healthyVolunteers":12,"sex":18,"minAge":162,"maxAge":4,"enrollmentInfo":414,"targetDuration":4,"studyType":56,"phases":416,"briefSummary":418,"conditions":419,"keywords":4,"overallStatus":33,"whyStopped":4,"lastUpdateSubmitDate":421,"lastUpdatePostDateStruct":422,"startDateStruct":423,"completionDateStruct":425,"leadSponsor":427,"locationsCount":429},"100609727","phase-4-a-study-of-pirtobrutinib-ly3527727-in-participants-with-chronic-lymphocytic-leukemiasmall-lymphocytic-lymphoma-100609727","NCT07218341","A Study of Pirtobrutinib (LY3527727) in Participants With Chronic Lymphocytic Leukemia\u002FSmall Lymphocytic Lymphoma","Long-Term Safety of Pirtobrutinib in Participants From Study LOXO-BTK-20020 With BTKi Pretreated Chronic Lymphocytic Leukemia\u002FSmall Lymphocytic Lymphoma","Inclusion Criteria:\n\n* Are actively participating in study J2N-MC-JZNN\u002FLOXO-BTK-20020\n\nExclusion Criteria:\n\n* This is not applicable to this study",{"count":415,"type":21},150,[417],"PHASE4","This study will evaluate the long-term safety of pirtobrutinib in participants with previously treated chronic lymphocytic leukemia (CLL) or small lymphocytic lymphoma (SLL). The study is open to those who completed J2N-MC-JZNN\u002FLOXO-BTK-20020 (NCT 04666038) for continued access to the study intervention or continued follow-up visits. Treatment will be given every 4 weeks and this study is expected to last about 5 years.",[25,420],"Lymphoma, Small Lymphocytic","2026-06-19",{"date":334,"type":37},{"date":424,"type":37},"2026-03-09",{"date":426,"type":21},"2032-12",{"name":428,"class":44},"Eli Lilly and Company",53,{"id":431,"slug":432,"hasResults":12,"nctId":433,"briefTitle":434,"officialTitle":435,"acronym":436,"eligibilityCriteria":437,"healthyVolunteers":12,"sex":18,"minAge":162,"maxAge":4,"enrollmentInfo":438,"targetDuration":4,"studyType":56,"phases":440,"briefSummary":441,"conditions":442,"keywords":443,"overallStatus":33,"whyStopped":4,"lastUpdateSubmitDate":444,"lastUpdatePostDateStruct":445,"startDateStruct":447,"completionDateStruct":449,"leadSponsor":451,"locationsCount":20},"100581158","phase-3-a-study-of-bgb-16673-compared-to-investigators-choice-in-participants-with-chronic-lymphocytic-leukemia-or-small-lymphocytic-lymphoma-previously-exposed-to-both-bruton-tyrosine-kinase-btk-and-b-cell-leukemialymphoma-2-protein-bcl2-inhibitors-100581158","NCT06846671","A Study of BGB-16673 Compared to Investigator's Choice in Participants With Chronic Lymphocytic Leukemia or Small Lymphocytic Lymphoma Previously Exposed to Both Bruton Tyrosine Kinase (BTK) and B-cell Leukemia\u002FLymphoma 2 Protein (BCL2) Inhibitors","A Phase 3, Open-Label, Randomized Study of BGB-16673 Compared to Investigator's Choice (Idelalisib Plus Rituximab or Bendamustine Plus Rituximab or Venetoclax Plus Rituximab Retreatment) in Patients With Chronic Lymphocytic Leukemia or Small Lymphocytic Lymphoma Previously Exposed to Both BTK and BCL2 Inhibitors","CaDAnCe-302","Inclusion Criteria:\n\n1. Confirmed diagnosis of CLL or SLL, requiring treatment, based on 2018 international workshop on chronic lymphocytic leukemia (iwCLL) criteria.\n2. Previously received treatment for CLL\u002FSLL with both a BTKi and a BCL2i.\n3. Participants with SLL must have measurable disease by computer tomography (CT)\u002Fmagnetic resonance imaging (MRI)\n4. Eastern Cooperative Oncology Group (ECOG) score 0, 1, or 2\n5. Adequate liver function\n6. Adequate blood clotting function\n\nExclusion Criteria:\n\n1. Known prolymphocytic leukemia or history of, or currently suspected, Richter's transformation\n2. Prior autologous stem cell transplant or chimeric antigen receptor-T cell therapy in the last 3 months\n3. Known central nervous system involvement\n4. Prior exposure to any BTK protein degraders\n5. Active fungal, bacterial and\u002For viral infection requiring parenteral systemic therapy\n6. Clinically significant cardiovascular disease\n\nNOTE: Other protocol defined Inclusion\u002FExclusion criteria may apply.",{"count":439,"type":21},250,[58],"The purpose of this study is to investigate the efficacy and safety of BGB-16673 compared with investigator's choice (idelalisib plus rituximab \\[for CLL only\\] or bendamustine plus rituximab or venetoclax plus rituximab retreatment) in participants with chronic lymphocytic leukemia (CLL) or small lymphocytic lymphoma (SLL) previously exposed to both BTK inhibitors (BTKi) and BCL2 inhibitors (BCL2i).",[397,25],[397],"2026-06-18",{"date":446,"type":37},"2026-06-22",{"date":448,"type":37},"2025-04-10",{"date":450,"type":21},"2030-02-14",{"name":452,"class":44},"BeOne Medicines",{"id":454,"slug":455,"hasResults":12,"nctId":456,"briefTitle":457,"officialTitle":458,"acronym":4,"eligibilityCriteria":459,"healthyVolunteers":12,"sex":18,"minAge":162,"maxAge":4,"enrollmentInfo":460,"targetDuration":4,"studyType":56,"phases":462,"briefSummary":463,"conditions":464,"keywords":465,"overallStatus":33,"whyStopped":4,"lastUpdateSubmitDate":468,"lastUpdatePostDateStruct":469,"startDateStruct":470,"completionDateStruct":472,"leadSponsor":474,"locationsCount":475},"100614256","phase-3-a-study-to-investigate-sonrotoclax-bgb-11417-plus-zanubrutinib-bgb-3111-compared-with-venetoclax-plus-acalabrutinib-in-adults-with-previously-untreated-chronic-lymphocytic-leukemia-100614256","NCT07277231","A Study to Investigate Sonrotoclax (BGB-11417) Plus Zanubrutinib (BGB-3111) Compared With Venetoclax Plus Acalabrutinib in Adults With Previously Untreated Chronic Lymphocytic Leukemia","A Phase 3, Open-Label, Randomized Study of Sonrotoclax (BGB-11417) Plus Zanubrutinib (BGB-3111) Compared With Venetoclax Plus Acalabrutinib in Patients With Previously Untreated Chronic Lymphocytic Leukemia","Inclusion Criteria:\n\n* Treatment-naïve (TN) adults with confirmed diagnosis of CLL which requires treatment\n* Eastern Cooperative Oncology Group (ECOG) score 0, 1, or 2\n* Measurable disease by Computer Tomography\u002FMagnetic Resonance Imaging\n* Adequate bone marrow and organ function\n\nExclusion Criteria:\n\n* Previous systemic treatment for CLL\n* Known prolymphocytic leukemia or history of, or currently suspected, Richter's transformation\n* Known central nervous system involvement\n* History of confirmed progressive multifocal leukoencephalopathy (PML)\n* Uncontrolled hypertension or clinically significant cardiovascular disease\n\nNote: Other protocol defined Inclusion\u002FExclusion criteria may apply.",{"count":461,"type":21},500,[58],"The purpose of this study is to investigate the efficacy and safety of fixed-duration sonrotoclax (also known as BGB-11417) plus zanubrutinib (also known as BGB-3111) (SZ) compared with fixed-duration of venetoclax plus acalabrutinib (AV) in participants with previously untreated chronic lymphocytic leukemia (CLL).",[25],[466,467],"B-cell Lymphoma-2 Inhibitor","Bruton Tyrosine Kinase Inhibitor","2026-06-17",{"date":444,"type":37},{"date":471,"type":37},"2026-01-22",{"date":473,"type":21},"2031-11",{"name":452,"class":44},77,{"id":477,"slug":478,"hasResults":12,"nctId":479,"briefTitle":480,"officialTitle":480,"acronym":481,"eligibilityCriteria":482,"healthyVolunteers":80,"sex":18,"minAge":162,"maxAge":4,"enrollmentInfo":483,"targetDuration":4,"studyType":56,"phases":485,"briefSummary":486,"conditions":487,"keywords":4,"overallStatus":33,"whyStopped":4,"lastUpdateSubmitDate":468,"lastUpdatePostDateStruct":502,"startDateStruct":503,"completionDateStruct":504,"leadSponsor":506,"locationsCount":45},"100590778","evaluation-of-skin-tests-in-biotherapy-allergies-100590778","NCT06971848","Evaluation of Skin Tests in Biotherapy Allergies","ETCABIO","Inclusion Criteria :\n\n* Patient treated with one of the biotherapies under study (Atezolizumab 1200 mg, Nivolumab 480 mg, Obinutuzumab 100 mg, Durvalumab 1500 mg, Pembrolizumab 200 mg, Daratumumab 1800 mg, Cemiplimab 3500 mg) and who has received at least two injections of the biotherapy without suspected allergic side effects.\n* Subjects covered by or having the rights to medical care assurance\n* Written informed consent obtained from subject\n* If applicable, treatment with corticosteroids and H1 antihistamines by systemic route (IV or oral) which may be discontinued at least one week before performing the tests (Inhaled corticosteroids are allowed).\n\nExclusion Criteria:\n\n* Presence of local or diffuse dermatological lesions (e.g., psoriasis, eczema, ...) that could interfere with the interpretation of skin tests.\n* Poor understanding of the French language\n* Pregnancy, breastfeeding\n* Persons in detention by judicial or administrative decision\n* Person admitted to a health or social establishment for purposes other than research\n* Person subject to a legal protection measure",{"count":484,"type":21},70,[238],"Biotherapies are biological (extracted from an organism or living tissue) or biotechnological drugs used in the treatment of multiple conditions, such as autoimmune inflammatory diseases, cancers, and hematologic diseases. In recent years, these biotherapies have notably emerged in the treatment of cancers and hematologic disorders. As such, most patients with cancers or hematologic diseases will likely receive a biotherapy as part of their care pathway.\n\nThese biotherapies are associated with various side effects, including hypersensitivity or allergic reactions, which are often poorly characterized in clinical trials. These reactions manifest as symptoms without specific dermatologic or allergologic semiology (such as itching, erythema, shortness of breath, sometimes digestive issues, or discomfort, and in some cases, an anaphylactic reaction).\n\nUnlike other treatments, such as antibiotics and neuromuscular blockers, there are currently no guidelines on the concentrations to use in skin tests for biotherapies. We propose conducting prospective clinical research to scientifically establish the concentrations to be used when investigating hypersensitivity to a biotherapy, in line with best practice recommendations for drug skin testing.",[488,489,490,491,492,493,25,243,494,495,496,497,498,499,500,501],"Locally Advanced Cutaneous Squamous Cell Carcinoma of the Head and Neck","Melanoma Neoplasms","Small Cell Bronchial Carcinomas","Bronchial Carcinoma","Pleural Mesothelioma","Hodgkin's Lymphoma","Myeloma","AL Amyloidosis","Hepatocarcinoma","Colorectal Cancer","Esophageal Squamous Cell Carcinoma","Heart Cancer","Cholangiocarcinoma","Colorectal Adenocarcinoma",{"date":444,"type":37},{"date":468,"type":37},{"date":505,"type":21},"2028-07",{"name":507,"class":508},"University Hospital, Angers","OTHER_GOV",{"id":510,"slug":511,"hasResults":12,"nctId":512,"briefTitle":513,"officialTitle":514,"acronym":4,"eligibilityCriteria":515,"healthyVolunteers":12,"sex":18,"minAge":162,"maxAge":4,"enrollmentInfo":516,"targetDuration":4,"studyType":56,"phases":517,"briefSummary":518,"conditions":519,"keywords":520,"overallStatus":33,"whyStopped":4,"lastUpdateSubmitDate":468,"lastUpdatePostDateStruct":523,"startDateStruct":524,"completionDateStruct":526,"leadSponsor":528,"locationsCount":529},"100590881","phase-3-a-study-to-evaluate-the-safety-and-efficacy-of-bgb-16673-compared-to-pirtobrutinib-in-adults-with-relapsedrefractory-chronic-lymphocytic-leukemia-or-small-lymphocytic-lymphoma-100590881","NCT06973187","A Study to Evaluate the Safety and Efficacy of BGB-16673 Compared to Pirtobrutinib in Adults With Relapsed\u002FRefractory Chronic Lymphocytic Leukemia or Small Lymphocytic Lymphoma","A Phase 3, Open-Label, Randomized Study to Evaluate the Safety and Efficacy of BGB-16673 Compared to Pirtobrutinib in Patients With Relapsed\u002FRefractory Chronic Lymphocytic Leukemia or Small Lymphocytic Lymphoma","Inclusion Criteria:\n\n* Confirmed diagnosis of CLL or SLL, requiring treatment, based on 2018 iwCLL criteria\n* Previously received treatment for CLL\u002FSLL with a covalent Bruton tyrosine kinase inhibitor (cBTKi). Patients should have disease relapsed after or refractory to at least 1 line of therapy including a cBTKi.\n* Participants with SLL must have measurable disease by computed tomography\u002Fmagnetic resonance imaging, defined as ≥ 1 lymph node \\> 1.5 cm in longest diameter and measurable in 2 perpendicular diameters.\n\nExclusion Criteria:\n\n* Known prolymphocytic leukemia or history of, or currently suspected, Richter's transformation.\n* History of known bleeding disorder such as hemophilia A, hemophilia B, von Willebrand disease, or history of spontaneous bleeding requiring blood transfusion or other medical intervention\n* History of ischemic stroke or intracranial hemorrhage within 6 months before first dose of study drug\n* Prior exposure to any Bruton tyrosine kinase (BTK) protein degraders or noncovalent Bruton tyrosine kinase inhibitor (ncBTKi).\n* Current or history of central nervous system involvement including the brain, spinal cord, leptomeninges, and cerebrospinal fluid (as documented by imaging, cytology, or biopsy) by CLL\u002FSLL\n\nNOTE: Other protocol defined Inclusion\u002FExclusion criteria may apply.",{"count":461,"type":21},[58],"The purpose of this study is to evaluate the efficacy and safety of BGB-16673 alone compared with pirtobrutinib in patients with relapsed or refractory (R\u002FR) chronic lymphocytic leukemia (CLL) or small lymphocytic lymphoma (SLL) who had been previously treated with a covalent Bruton tyrosine kinase inhibitor (cBTKi).",[25,168],[521,522],"Noncovalent Bruton tyrosine kinase inhibitor","Bruton tyrosine kinase-targeted protein degrader",{"date":444,"type":37},{"date":525,"type":37},"2025-09-04",{"date":527,"type":21},"2028-04-17",{"name":452,"class":44},167,{"id":531,"slug":532,"hasResults":12,"nctId":533,"briefTitle":534,"officialTitle":535,"acronym":536,"eligibilityCriteria":537,"healthyVolunteers":12,"sex":18,"minAge":162,"maxAge":4,"enrollmentInfo":538,"targetDuration":4,"studyType":56,"phases":540,"briefSummary":541,"conditions":542,"keywords":4,"overallStatus":33,"whyStopped":4,"lastUpdateSubmitDate":468,"lastUpdatePostDateStruct":547,"startDateStruct":548,"completionDateStruct":550,"leadSponsor":552,"locationsCount":553},"100439778","phase-1-a-dose-escalation-and-expansion-study-of-bgb-16673-in-participants-with-b-cell-malignancies-100439778","NCT05006716","A Dose-Escalation and Expansion Study of BGB-16673 in Participants With B-Cell Malignancies","A Phase 1\u002F2, Open-Label, Dose-Escalation and -Expansion Study of the Bruton Tyrosine Kinase Targeted Protein Degrader BGB-16673 in Patients With B-Cell Malignancies","CaDAnCe-101","Inclusion Criteria :\n\n1. Confirmed diagnosis (per World Health Organization (WHO) guidelines, unless otherwise noted) of one of the following: Marginal Zone Lymphoma (MZL), R\u002FR follicular lymphoma (FL), mantle cell lymphoma (MCL), chronic lymphocytic leukemia and small lymphocytic lymphoma (CLL\u002FSLL), Waldenström macroglobulinemia (WM), R\u002FR diffuse large B-cell lymphoma (DLBCL), or Richter's transformation to DLBCL.\n2. Participants who have previously received a covalently-binding Bruton´s tyrosine kinase (BTK) inhibitor (BTKi) in any line of therapy must have received treatment with the BTK inhibitor for ≥ 8 weeks (unless reason for discontinuation is intolerance).\n3. For dose-finding and dose-expansion, participants who had previously received a covalently-binding BTK inhibitor as monotherapy or in combination with other anticancer agents are eligible for the study if they meet any of the following criteria: discontinued the previous BTK inhibitor due to disease progression, experienced disease progression after completing treatment with a BTK inhibitor or discontinued the BTK inhibitor due to toxicity or intolerance.\n4. Phase 2 Cohorts in R\u002FR CLL\u002FSLL, R\u002FR MCL, and R\u002FR WM only: Participants who previously received a BTKi are eligible if they had disease progression on only one regimen containing a covalent BTKi. Note: Participants may have received treatment with ≥ 2 different covalent BTKis if additional BTKis were discontinued secondary to an event other than disease progression.\n5. Measurable disease by radiographic assessment or serum IgM level (WM only)\n6. Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 to 2\n7. Participants enrolling in the dose finding phase of the study may be previously treated with a BTKi or may be naïve to BTKi therapy depending on the diagnosis and country of enrollment; participants with MCL enrolling in the expansion cohorts (Phase 2) must have been treated with a BTKi in a prior line of therapy; CLL\u002FSLL participants, in addition to being treated with a BTKi in a prior line of therapy, must also have received a Bcl-2 inhibitor in a prior line of therapy as well (Phase 2).\n\nExclusion Criteria:\n\n1. Prior malignancy (other than the disease under study) within the past 2 years, except in situ malignancies that have been curatively resected, localized breast cancer treated with curative intent with no evidence of breast active disease for more than 3 years and receiving adjuvant hormonal therapy, localized Gleason score ≤ 6 prostate cancer undergoing observation or treatment with androgen depravation, or any other cancer treated with curative intent, not on adjuvant treatment, and in the opinion of the investigator is unlikely to recur.\n2. Requires ongoing systemic treatment for any other malignancy\n3. Requires ongoing systemic (defined as ≥ 10 mg\u002Fday of prednisone or equivalent) corticosteroid treatment.\n4. Current or history of central nervous system involvement including the brain, spinal cord, leptomeninges, and cerebrospinal fluid (as documented by imaging, cytology, or biopsy) by B-cell malignancy, regardless of whether participants had received treatment for central nervous system disease\n5. Known active plasma cell neoplasm, prolymphocytic leukemia, T-cell lymphoma, Burkitt lymphoma, acquired immunodeficiency syndrome (AIDS)-related B-cell lymphoma, Castleman disease, post-transplant lymphoproliferative disorders, hairy cell leukemia, germinal center B-cell (GCB), DLBCL, EBV+ DLBCL NOS, primary DLBCL of the central nervous system (CNS), primary cutaneous DLBCL - leg type, DLBCL associated with chronic inflammation, primary mediastinal (thymic) large B-cell lymphoma, intravascular large B-cell lymphoma, ALK+ large B-cell lymphoma, primary effusion lymphoma, high-grade B-cell lymphoma with MYC and BCL2 and\u002For BCL6 rearrangements, high-grade B-cell lymphoma - NOS, B-cell lymphoma unclassifiable with features intermediate between DLBCL and classical Hodgkin lymphoma, or history of or currently suspected transformation of an indolent lymphoma to an aggressive histology (except for participants with Richter Transformation to DLBCL are eligible for Part 1a, 1c, or Phase 2 and participants with history of follicular lymphoma transforming to non-GCB DLBCL who are eligible for Part 1a, 1c, or Phase 2).\n\nNote: Other protocol defined Inclusion\u002FExclusion criteria may apply.",{"count":539,"type":21},645,[188,217],"Study consists of two main parts to explore BGB-16673 recommended dosing, a Phase 1 monotherapy dose finding comprised of monotherapy dose escalation and monotherapy safety expansion of selected doses, and a Phase 2 (expansion cohorts)",[543,244,243,199,544,25,168,545,546],"B-cell Malignancy","Waldenström Macroglobulinemia","Mantle Cell Lymphoma","Diffuse Large B Cell Lymphoma",{"date":444,"type":37},{"date":549,"type":37},"2021-09-13",{"date":551,"type":21},"2029-11",{"name":452,"class":44},127,{"id":555,"slug":556,"hasResults":12,"nctId":557,"briefTitle":558,"officialTitle":559,"acronym":560,"eligibilityCriteria":561,"healthyVolunteers":12,"sex":18,"minAge":162,"maxAge":4,"enrollmentInfo":562,"targetDuration":4,"studyType":56,"phases":564,"briefSummary":565,"conditions":566,"keywords":569,"overallStatus":33,"whyStopped":4,"lastUpdateSubmitDate":574,"lastUpdatePostDateStruct":575,"startDateStruct":576,"completionDateStruct":578,"leadSponsor":580,"locationsCount":582},"100458832","phase-3-a-study-of-pirtobrutinib-loxo-305-versus-ibrutinib-in-participants-with-chronic-lymphocytic-leukemia-cllsmall-lymphocytic-lymphoma-sll-100458832","NCT05254743","A Study of Pirtobrutinib (LOXO-305) Versus Ibrutinib in Participants With Chronic Lymphocytic Leukemia (CLL)\u002FSmall Lymphocytic Lymphoma (SLL)","A Phase 3 Open-Label, Randomized Study of Pirtobrutinib (LOXO-305) Versus Ibrutinib in Patients With Chronic Lymphocytic Leukemia\u002FSmall Lymphocytic Lymphoma (BRUIN-CLL-314)","BRUIN-CLL-314","Inclusion Criteria:\n\n* Confirmed diagnosis of CLL\u002FSLL requiring therapy per iwCLL 2018 criteria\n* Part 1 - Known 17p deletion status (wildtype or deleted). Part 2 - Must have deletion of 17p as determined by FISH testing\n* Eastern Cooperative Oncology Group (ECOG) Performance Status 0-2\n* Adequate organ function\n\n  * Platelets greater than or equal to ≥ 50 x 10⁹\u002Fliter (L) or ≥30 x 10⁹\u002FL in participants with documented bone marrow involvement considered to impair hematopoiesis,\n  * Hemoglobin ≥8 grams\u002Fdeciliter (g\u002FdL) or ≥6 g\u002FdL in participants with documented bone marrow involvement considered to impair hematopoiesis\n  * Absolute neutrophil count ≥0.75 x 10⁹\u002FL or ≥0.50 × 10⁹\u002FL in participants with documented bone marrow involvement considered to impair hematopoiesis\n  * Kidney function: Estimated creatinine clearance ≥30 milliliters per minute (mL\u002Fmin)\n\nExclusion Criteria:\n\n* Known or suspected Richter's transformation to diffuse large B-cell lymphoma (DLBCL), prolymphocytic leukemia, or Hodgkin's lymphoma at any time preceding enrollment\n* Known or suspected central nervous system (CNS) involvement\n* A significant history of renal, neurologic, psychiatric, endocrine, metabolic or immunologic disease\n* Active uncontrolled auto-immune cytopenia (e.g., autoimmune hemolytic anemia \\[AIHA\\], idiopathic thrombocytopenic purpura \\[ITP\\])\n* Significant cardiovascular disease including ejection fraction \\\u003C 40% and any grade ongoing atrial fibrillation or atrial flutter\n* Hepatitis B or hepatitis C testing indicating active\u002Fongoing infection, based on Screening laboratory tests\n* Active cytomegalovirus (CMV) infection\n* Active uncontrolled systemic bacterial, viral, or fungal infection\n* Known human immunodeficiency virus (HIV) infection, regardless of cluster of differentiation 4 (CD4) count\n* Clinically significant active malabsorption syndrome or other condition likely to affect GI absorption of the oral-administered study treatments\n* Ongoing inflammatory bowel disease\n* Previous treatment for CLL\u002FSLL - Part 1: Treatment-naïve and previously treated, except prior exposure to BTK inhibitor (covalent or noncovalent).\n\nPart 2: participants must be treatment naïve\n\n* Concurrent use of investigational agent or anticancer therapy except hormonal therapy\n* Participants requiring therapeutic anticoagulation with warfarin or another Vitamin K antagonist\n* Use of \\> 20 mg prednisone daily or equivalent dose of steroid at the time of first dose of study drug\n* Vaccination with a live vaccine within 28 days prior to randomization\n* Participants receiving chronic therapy with a strong cytochrome P450 (CYP)3A inhibitor (except posaconazole and voriconazole) which cannot be stopped within 3-5 half lives of the CYP3A inhibitor therapy prior to start of study drug treatment\n* Participants with known hypersensitivity, including anaphylaxis, to any component or excipient of pirtobrutinib or ibrutinib",{"count":563,"type":21},737,[58],"The purpose of Part 1 of this study is to compare the efficacy and safety of pirtobruitinib (LOXO-305) to ibrutinib in participants with CLL\u002FSLL; participants may or may not have already had treatment for their cancer. The purpose of Part 2 of this study evaluates pirtobrutinib monotherapy in treatment-naïve participants with CLL\u002FSLL with 17p deletions. Participation could last up to six years for Part 1. Participation could last up to 2 years for Part 2.",[25,567,568,168],"Leukemia, Lymphocytic","Leukemia, B-cell",[570,571,572,573],"BTKi","Hematologic Disease","Lymphoma, non-Hodgkin's","Lymphoma, B-cell","2026-06-16",{"date":468,"type":37},{"date":577,"type":37},"2022-07-22",{"date":579,"type":21},"2028-01",{"name":581,"class":44},"Loxo Oncology, Inc.",143,{"id":584,"slug":585,"hasResults":12,"nctId":586,"briefTitle":587,"officialTitle":588,"acronym":4,"eligibilityCriteria":589,"healthyVolunteers":80,"sex":18,"minAge":162,"maxAge":4,"enrollmentInfo":590,"targetDuration":4,"studyType":56,"phases":592,"briefSummary":594,"conditions":595,"keywords":597,"overallStatus":33,"whyStopped":4,"lastUpdateSubmitDate":600,"lastUpdatePostDateStruct":601,"startDateStruct":602,"completionDateStruct":604,"leadSponsor":606,"locationsCount":45},"100564976","early-phase-1-64cu-llp2a-for-imaging-hematologic-malignancies-100564976","NCT06636175","64Cu-LLP2A for Imaging Hematologic Malignancies","Early Phase I Evaluation of 64Cu-LLP2A for Imaging Hematologic Malignancies Part B","Inclusion Criteria Healthy Volunteer:\n\n* Adult 18 years of age or older\n* Able to give informed consent.\n* Able to comprehend and willing to follow instructions for study procedures as called for by the protocol\n* Capable of lying still and supine within the PET\u002FCT scanner for up to 75 minutes.\n* No illicit drug use or other inhaled drug use (including pharmacologic agents and illicit drugs) within the past year per self-reporting mechanisms.\n* No history of claustrophobia or other condition that has previously or would interfere with completion of protocol specified imaging sessions.\n* Not currently pregnant or nursing: Subject must be surgically sterile (has had a documented bilateral oophorectomy and\u002For documented hysterectomy), post-menopausal (cessation of menses for more than 1 year), non-lactating, or of childbearing potential for whom a urine pregnancy test (with the test performed within the 24 hour period immediately prior to administration of 64Cu-LLP2A) is negative.\n\nInclusion Criteria Hematological Malignancy:\n\n* Clinical or pathologically defined MM or lymphoma including both newly diagnosed, relapsed or refractory disease:\n\n  * Multiple Myeloma defined in accordance with the International Myeloma Working Group criteria\n  * Low-grade lymphoma, including the following subtypes: follicular lymphoma, marginal zone lymphoma, lymphoplasmacytic lymphoma, small lymphocytic lymphoma\u002Fchronic lymphocytic leukemia\n* Adult 18 years of age or older and able to provide informed consent\n* Capable of lying still and supine within the PET\u002FCT scanner for up to 75 minutes.\n* No history of claustrophobia or other condition that has previously or would interfere with completion of protocol specified imaging sessions\n* Not currently pregnant or nursing: Subject must be surgically sterile (has had a documented bilateral oophorectomy and\u002For documented hysterectomy), post-menopausal (cessation of menses for more than 1 year), non-lactating, or of childbearing potential for whom a urine pregnancy test (with the test performed within the 24 hour period immediately prior to administration of 64Cu-LLP2A) is negative\n* Patients participating in imaging or therapeutic trials with investigational agents are eligible to participate",{"count":591,"type":21},42,[593],"EARLY_PHASE1","This phase of the protocol (protocol part B), seeks to evaluate the new formulation in healthy normal volunteers to confirm the new formulation provides comparable human dosimetry to which was seen and published in protocol part A. Additionally, the new formulation will be studied utilizing an expanded patient population to include patients with confirmed diagnosis of multiple myeloma (MM), low-grade lymphoma, or MM and lymphoma patients who are status post bone marrow transplant (BMT) with negative imaging and suspected recurrence.",[287,596,243,244,245,168,25],"Low-Grade Lymphoma",[598,599],"PET","Imaging","2026-06-15",{"date":468,"type":37},{"date":603,"type":37},"2025-03-20",{"date":605,"type":21},"2027-03-31",{"name":607,"class":71},"Washington University School of Medicine",{"id":609,"slug":4,"hasResults":12,"nctId":13,"briefTitle":14,"officialTitle":15,"acronym":16,"eligibilityCriteria":17,"healthyVolunteers":12,"sex":18,"minAge":4,"maxAge":4,"enrollmentInfo":610,"targetDuration":4,"studyType":22,"phases":4,"briefSummary":23,"conditions":611,"keywords":612,"overallStatus":33,"whyStopped":4,"lastUpdateSubmitDate":600,"lastUpdatePostDateStruct":613,"startDateStruct":614,"completionDateStruct":615,"leadSponsor":616,"locationsCount":45},"100558210",{"count":20,"type":21},[25],[27,28,29,30,31,32],{"date":574,"type":37},{"date":39,"type":37},{"date":41,"type":21},{"name":43,"class":44},{"id":618,"slug":619,"hasResults":12,"nctId":620,"briefTitle":621,"officialTitle":622,"acronym":623,"eligibilityCriteria":624,"healthyVolunteers":12,"sex":18,"minAge":162,"maxAge":4,"enrollmentInfo":625,"targetDuration":4,"studyType":22,"phases":4,"briefSummary":627,"conditions":628,"keywords":629,"overallStatus":33,"whyStopped":4,"lastUpdateSubmitDate":630,"lastUpdatePostDateStruct":631,"startDateStruct":632,"completionDateStruct":634,"leadSponsor":636,"locationsCount":45},"100615123","observ-prosp-study-of-acalabrutinib-in-cll-therapy-in-real-clinical-practice-in-belarus-100615123","NCT07288515","Observ Prosp Study of Acalabrutinib in CLL Therapy in Real Clinical Practice in Belarus","Observational Prospective Study of Acalabrutinib in Chronic Lymphocytic Leukemia Therapy in Real Clinical Practice in Belarus.","ALICIA(BY)","Inclusion Criteria:\n\n* Age ≥18 years.\n* Confirmed diagnosis of CLL.\n* Newly prescribed acalabrutinib monotherapy within the previous four weeks preceding study enrolment. Monotherapy is defined as acalabrutinib prescribes without concomitant administration (or planned initiation) of other anti-leukemic agents (e.g. obinutuzumab, venetoclax, bendamustine) within ± 30 days of acalabrutinib initiation.\n* Treatment-naïve or R\u002FR CLL.\n* Ability and willingness to provide informed consent for study participation.\n\nExclusion Criteria:\n\n* Patients not satisfying any of the inclusion criteria.\n* Prior treatment with any BTK inhibitor.\n* Participation in other ongoing clinical trials.\n* Pregnant or breastfeeding females",{"count":626,"type":21},50,"to address critical gap in knowledge, providing essential data on the real-world effectiveness, safety, associated with acalabrutinib treatment in patients with CLL",[25],[397],"2026-06-12",{"date":600,"type":37},{"date":633,"type":37},"2025-12-31",{"date":635,"type":21},"2029-12-31",{"name":43,"class":44},{"id":638,"slug":639,"hasResults":12,"nctId":640,"briefTitle":641,"officialTitle":642,"acronym":4,"eligibilityCriteria":643,"healthyVolunteers":12,"sex":18,"minAge":162,"maxAge":4,"enrollmentInfo":644,"targetDuration":4,"studyType":56,"phases":646,"briefSummary":647,"conditions":648,"keywords":650,"overallStatus":33,"whyStopped":4,"lastUpdateSubmitDate":653,"lastUpdatePostDateStruct":654,"startDateStruct":655,"completionDateStruct":657,"leadSponsor":659,"locationsCount":661},"100613828","phase-2-a-study-of-emavusertib--an-approved-bruton-tyrosine-kinase-inhibitor-btki-in-participants-with-chronic-lymphocytic-leukemia-cll-and-other-b-cell-malignancies-100613828","NCT07271667","A Study of Emavusertib + An Approved Bruton Tyrosine Kinase Inhibitor (BTKi) in Participants With Chronic Lymphocytic Leukemia (CLL) and Other B-cell Malignancies","A Phase 2 Study of Emavusertib in Combination With an Approved Bruton Tyrosine Kinase Inhibitor in Patients With Chronic Lymphocytic Leukemia and Other B-cell Malignancies","Inclusion Criteria (All Parts):\n\n1. Males and females ≥ 18 years of age.\n2. Life expectancy of ≥ 3 months.\n3. Eastern Cooperative Oncology Group Performance Status of 0, 1, or 2.\n4. Histopathologically confirmed diagnosis of CLL (medical record is acceptable), as per the World Health Organization 2016 classification.\n5. At least 1 criterion for measurable disease per International Workshop on Chronic Lymphocytic Leukemia (iwCLL).\n6. For Cohort 1 only:\n\n   1. Participant must be in a partial response (PR) or partial response with lymphocytosis (PR-L) and measurable residual disease positive (MRD+) per Hallek et al, (2018) criteria.\n   2. Participant must have detectable measurable residual disease (MRD) as determined by the ClonoSEQ assay\n   3. Must be actively taking zanubrutinib for at least 12 months.\n   4. Acceptable organ function at Screening within 28 days prior to Cycle 1 Day 1 (C1D1)\n7. For Cohort 2 only:\n\n   1. Relapsed disease for which participants are ineligible for or have exhausted standard therapeutic options that would be considered standard of care\n   2. Must be actively taking zanubrutinib.\n   3. Participants must have had direct progression on zanubrutinib (within 3 months prior to study entry; administered as monotherapy or in combination) and no other anticancer therapy administered since.\n   4. Acceptable organ function at Screening within 28 days prior to C1D1.\n8. Creatine phosphokinase (CPK) \\\u003C 2.5 × ULN.\n9. Ability to tolerate a contrast-enhanced computed tomography (CT) scan.\n10. Ability to swallow and retain oral medications.\n11. Negative serum pregnancy test in women of childbearing potential (WOCP).\n12. WOCP and men who partner with WOCP must agree to use highly effective contraceptive methods for the duration of the study and for 180 days after the last dose of study treatment.\n13. Ability to understand and willingness to sign a written informed consent document. Legally authorized representatives may sign and give informed consent on behalf of study participants.\n\nExclusion Criteria (All Parts):\n\n1. Active second malignancy unless in remission with a life expectancy of \\> 2 years and with documented Sponsor approval.\n2. Active malignancy other than CLL requiring systemic therapy (exceptions may be granted following a discussion with the Sponsor Medical Monitor).\n3. Have high-risk CLL TP53 mutations and 17P deletion.\n4. History of Grade ≥ 3 rhabdomyolysis without complete recovery.\n5. Received prior chimeric antigen receptor-T cell therapy.\n6. Received prior investigational drugs (including treatment in clinical research, unapproved combination products, and new dosage forms) within 28 days or 5 half-lives, whichever is shorter, prior to C1D1; allogeneic hematopoietic stem cell transplant (HSCT) within 60 days prior to C1D1; or had clinically significant graft-versus-host disease (GVHD) requiring ongoing uptitration of immunosuppressive medications prior to Screening.\n7. Any prior systemic anticancer treatment such as chemotherapy, immunomodulatory drug therapy, etc., received within 21 days or 5 half-lives, whichever is shorter, prior to C1D1 (with the exception of zanubrutinib, which may be continued until the day before C1D1).\n8. Receiving the following medications within 7 days or 5 half-lives, whichever is shorter, prior to C1D1:\n\n   1. Medications that, in the opinion of the Investigator, have a high risk of causing prolonged QT interval, corrected (QTc) and\u002For Torsades de Pointes.\n   2. Peg-filgrastim or equivalent.\n   3. St John's Wort.\n9. History of or ongoing drug-induced pneumonitis.\n10. History of stroke or intracranial hemorrhage within 6 months prior to C1D1. Participants with post-biopsy hemorrhagic sequela defined as a small hyperdense lesion \\\u003C 3 millimeters (mm) on T2 sequence will not be excluded.\n11. Requirement for anticoagulation with warfarin or equivalent vitamin K antagonists, including dual antiplatelet agents, within 5 half-lives of the anticoagulant or 7 days, whichever is longer, prior to C1D1. Low molecular weight heparin is allowed. Participants who require the use of antiplatelet agents should be discussed with the Sponsor Medical Monitor (e.g., use of factor Xa inhibitors).\n12. Vaccinated with a live-attenuated vaccine within 4 weeks prior to C1D1.\n13. Prior history of hypersensitivity or anaphylaxis to emavusertib, zanubrutinib, or any of their excipients.\n14. Prior history of Stevens-Johnson syndrome or toxic epidermal necrolysis.\n15. Intolerance to contrast-enhanced CT scan due to allergic reactions to contrast agents.\n16. Major surgery \\\u003C 28 days prior to C1D1; minor surgery \\\u003C 7 days prior to C1D1.\n17. Viral infections:\n\n    1. Known to be human immunodeficiency virus (HIV) positive or have an acquired immunodeficiency syndrome (AIDS)-related illness. If HIV is undetectable or maintained on treatment, enrollment may be allowed after discussion with the Sponsor Medical Monitor.\n    2. Hepatitis B virus (HBV) deoxyribonucleic acid (DNA) positive or hepatitis C virus (HCV) infection \\\u003C 6 months prior to C1D1, unless viral load is undetectable, or HCV with cirrhosis.\n    3. Active systemic infection, including HIV, cytomegalovirus infection, or severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) infection, or has had, within 28 days prior to C1D1, an infection (other than nail trichophytosis) that requires hospitalization or an intravenous antibiotic.\n18. Concomitant illness that would preclude safe participation in the study.\n19. Pregnant or lactating female.",{"count":645,"type":21},108,[217],"The primary objective of the study for Cohort 1 and Cohort 2 is to assess the anticancer activity of emavusertib in combination with zanubrutinib in participants with CLL.",[25,649],"B-cell Malignancies",[651,570,649,25,397,652],"Emavusertib","Zanubrutinib","2026-06-11",{"date":630,"type":37},{"date":656,"type":37},"2026-04-23",{"date":658,"type":21},"2027-11",{"name":660,"class":44},"Curis, Inc.",11,{"id":663,"slug":664,"hasResults":12,"nctId":665,"briefTitle":666,"officialTitle":667,"acronym":668,"eligibilityCriteria":669,"healthyVolunteers":12,"sex":18,"minAge":162,"maxAge":4,"enrollmentInfo":670,"targetDuration":4,"studyType":56,"phases":671,"briefSummary":672,"conditions":673,"keywords":678,"overallStatus":33,"whyStopped":4,"lastUpdateSubmitDate":685,"lastUpdatePostDateStruct":686,"startDateStruct":688,"completionDateStruct":690,"leadSponsor":692,"locationsCount":694},"100434327","phase-2-faecal-microbiota-transplantation-after-allogeneic-stem-cell-transplantation-100434327","NCT04935684","Faecal Microbiota Transplantation After Allogeneic Stem Cell Transplantation","Faecal Microbiota Transplantation for Prevention of Graft-versus-host Sisease After Allogeneic Stem Cell Transplantation for Haematological Malignancies","TMF-Allo","Inclusion Criteria:\n\n* Patient aged 18 or over\n* Men and women\n* Patients affiliated with a social-security organization\n* Patients undergoing a myelo-ablative allo-HSCT for a controlled haematologic malignant disease, with peripheral stem cells, whatever the type of donor (except cord blood)\n* Signed and dated informed consent\n\nExclusion Criteria:\n\n* Status of tumor progression at the time of allo-HSCT\n* Inability to understand the protocol (linguistic barrier, cognitive difficulties)\n* Medical history of another progressive cancer or occurrence in the 3 previous years (excluding basal cell carcinoma)\n* Presence of a simultaneous serious and uncontrolled disease (severe cardiac, renal, hepatic or respiratory failure, severe sepsis)\n* Fecal incontinence\n* Participation in another clinical trial studying an allograft procedure including the type of graft, the type of immunosuppression, a preventive or a curative treatment of GvHD, or studying the effectiveness of a FMT in another indication.\n* Pregnant women\n* Patient under guardianship, curatorship or protection of justice",{"count":415,"type":21},[217],"The aim of this study is to assess the Fecal Microbiota Transplantation (FMT) efficacy in the prevention of allogeneic hematopoietic stem cell transplantation (allo-HSCT) complications and particularly Graft versus Host Disease (GvHD).\n\nThe hypothesis of this study is that allogeneic FMT may improve outcomes of these patients.",[674,675,676,194,677,494,25],"Acute Leukemia in Remission","Myelodysplastic Syndromes","Myeloproliferative Syndrome","Lymphoma, Non-Hodgkin",[679,680,681,682,683,684],"Allogeneic hematopoietic stem cell transplantation","Hematologic malignancies","Graft versus Host Disease","Intestinal microbiota","Intestinal dysbiosis","Fecal Microbiota Transplantation","2026-06-08",{"date":687,"type":37},"2026-06-09",{"date":689,"type":37},"2022-12-20",{"date":691,"type":21},"2030-05",{"name":693,"class":71},"University Hospital, Clermont-Ferrand",20]