[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"cll-chronic-lymphocytic-leukemia\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:cll-chronic-lymphocytic-leukemia":28},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,9,0,[8,47,75,98,160,187,222,260,281],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":13,"acronym":4,"eligibilityCriteria":14,"healthyVolunteers":11,"sex":15,"minAge":16,"maxAge":17,"enrollmentInfo":18,"targetDuration":4,"studyType":21,"phases":4,"briefSummary":22,"conditions":23,"keywords":29,"overallStatus":36,"whyStopped":4,"lastUpdateSubmitDate":37,"lastUpdatePostDateStruct":38,"startDateStruct":41,"completionDateStruct":4,"leadSponsor":43,"locationsCount":46},"100127162","natural-history-study-of-monoclonal-b-cell-lymphocytosis-mbl-chronic-lymphocytic-leukemiasmall-lymphocytic-lymphoma-cllsll-lymphoplasmacytic-lymphoma-lplwaldenstrom-macroglobulinemia-wm-and-splenic-marginal-zone-lymphoma-smzl-100127162",false,"NCT00923507","Natural History Study of Monoclonal B Cell Lymphocytosis (MBL), Chronic Lymphocytic Leukemia\u002FSmall Lymphocytic Lymphoma (CLL\u002FSLL), Lymphoplasmacytic Lymphoma (LPL)\u002FWaldenstrom Macroglobulinemia (WM), and Splenic Marginal Zone Lymphoma (SMZL)","-INCLUSION CRITERIA:\n\n1. Diagnosis of CLL\u002FSLL will be made according to the updated criteria of the NCI Working Group.\n\n   * on treatment or previously treated\n   * requiring or nearing first-line treatment\n\n   OR\n\n   Diagnosis of LPL\u002FWM. LPL is defined as the presence of an intertrabecular pattern of bone marrow infiltration by small lymphocytes showing plasmacytoid\u002Fplasma cell differentiation. WM, comprising \\>95% of LPL cases, describes the clinical syndrome of LPL associated with an IgM monoclonal gammopathy of any concentration. The remaining cases may be IgA, IgM, or non-secreting LPL. Immunophenotyping is required for diagnosis\n2. Age greater than or equal to 18 years.\n3. ECOG performance status of 0-2.\n4. Able to comprehend the investigational nature of the protocol and provide informed consent\n\nEXCLUSION CRITERIA:\n\n1\\. None","ALL","18 Years","110 Years",{"count":19,"type":20},1000,"ESTIMATED","OBSERVATIONAL","Background\n\nThe development of new technologies now allow scientists to investigate the molecular basis and clinical manifestations of monoclonal B cell lymphocytosis (MBL), chronic lymphocytic leukemia(CLL)\u002Fsmall lymphocytic lymphoma (SLL), lymphoplasmacytic lymphoma (LPL)\u002FWaldenstrom macroglobulinemia (WM), and splenic marginal zone lymphoma (SMZL). Applying these methods in a natural history study can help identify processes involved in disease progression, and possibly lead to the discovery or validation of treatment targets.\n\nObjectives\n\nStudy the history of MBL\u002FCLL\u002FSLL\u002FLPL\u002FWM\u002FSMZL in patients prior to and after treatment. Characterize clinical, biologic and molecular events of disease stability and progression of patients enrolled on this protocol.\n\nEligibility:\n\n* Diagnosis of CLL\u002FSLL and on treatment\u002Fpreviously treated\u002Fnearing treatment\n* Diagnosis of LPL\u002FWM\n* As of February 5, 2025, patients with MBL and SMZL will no longer be enrolled.\n* Age greater than or equal to 18 years.\n* ECOG performance status of 0-2.\n\nDesign\n\nPatients are typically followed every 6 to 24 months in the clinic and have blood drawn. Patients may be asked to undergo additional testing, including bone marrow biopsy and aspiration, lymph node biopsy, positron emission tomography, and CT and MRI scans. Some of these tests (e.g., blood draw) may be required to monitor CLL\u002FSLL and LPL\u002FWM. Other tests (e.g., lymph node biopsy) may not be clinically indicated, but patients may be asked to undergo these procedures for research purposes.\n\nNo treatment will be administered on this study. If a patients requires treatment for their cancer, available NIH clinical trials and alternative treatment options will be discussed with the patient.\n\n...",[24,25,26,27,28],"Waldenstrom Macroglobulinemia","Lymphoplasmacytic Lymphoma","Monoclonal B-Cell Lymphocytosis","Small Lymphocytic Lymphoma","CLL (Chronic Lymphocytic Leukemia)",[30,31,32,33,34,35],"Chronic Lymphocytic Leukemia (CLL)","Monoclonal B Cell Lymphocytosis","Small Lymphocytic Lymphoma (SLL)","Natural History","Leukemia","Lymphoma","RECRUITING","2026-06-27",{"date":39,"type":40},"2026-06-30","ACTUAL",{"date":42,"type":40},"2008-05-29",{"name":44,"class":45},"National Heart, Lung, and Blood Institute (NHLBI)","NIH",1,{"id":48,"slug":49,"hasResults":11,"nctId":50,"briefTitle":51,"officialTitle":52,"acronym":4,"eligibilityCriteria":53,"healthyVolunteers":11,"sex":15,"minAge":16,"maxAge":54,"enrollmentInfo":55,"targetDuration":4,"studyType":57,"phases":58,"briefSummary":60,"conditions":61,"keywords":62,"overallStatus":36,"whyStopped":4,"lastUpdateSubmitDate":65,"lastUpdatePostDateStruct":66,"startDateStruct":68,"completionDateStruct":70,"leadSponsor":72,"locationsCount":46},"100644468","phase-2-a-study-of-mrd-guided-zanubrutinib-plus-sonrotoclax-in-treatment-nave-high-risk-cllsll-patients-100644468","NCT07671378","A Study of MRD-Guided Zanubrutinib Plus Sonrotoclax in Treatment-Naïve, High-Risk CLL\u002FSLL Patients","A Prospective Study of MRD-Guided, Time-Limited Therapy With Zanubrutinib Plus Sonrotoclax in Treatment-Naïve, High-Risk Chronic Lymphocytic Leukemia\u002FSmall Lymphocytic Lymphoma (CLL\u002FSLL) Patients","Inclusion Criteria:\n\n* Patients must meet all of the following inclusion criteria to be enrolled in this study:\n\nAge between 18 and 75 years, inclusive. Diagnosis of CLL\u002FSLL according to the International Workshop on Chronic Lymphocytic Leukemia (iwCLL) 2018 criteria.\n\nMeeting iwCLL 2018 treatment indications and carrying at least one high-risk factor, including CLL-IPI high-risk\u002Fvery high-risk, del(11q), del(17p)\u002FTP53 mutation, unmutated IGHV, or complex karyotype.\n\nMeasurable disease: presence of measurable lymphadenopathy by computed tomography (CT) scan.\n\nECOG performance status of 0 to 2.\n\nAdequate major organ function meeting the following criteria:\n\n1. Hematologic function: without transfusion or hematopoietic growth factor support for at least 7 days prior to enrollment (at least 14 days for pegylated G-CSF such as pegfilgrastim), and meeting the following criteria: absolute neutrophil count (ANC) \\> 0.75 × 10⁹\u002FL, platelet count (PLT) \\> 30 × 10⁹\u002FL, hemoglobin (Hb) \\> 80 g\u002FL.\n2. Serum aspartate aminotransferase (AST) or alanine aminotransferase (ALT) ≤ 3.0 × upper limit of normal (ULN).\n3. Creatinine clearance (CrCl) ≥ 60 mL\u002Fmin (estimated by Cockcroft-Gault formula).\n4. Total bilirubin (TBIL) ≤ 1.5 × ULN (unless due to Gilbert's syndrome or other non-hepatic causes).\n5. Coagulation function: prothrombin time (PT)\u002Finternational normalized ratio (INR) \\\u003C 1.5 × ULN, activated partial thromboplastin time (APTT) \\\u003C 1.5 × ULN (exceptions may be considered on a case-by-case basis if clearly unrelated to coagulopathy or bleeding disorders).\n\nLife expectancy ≥ 6 months. Female subjects of non-childbearing potential (e.g., postmenopausal for ≥ 1 year with amenorrhea, history of hysterectomy, bilateral tubal ligation, or bilateral oophorectomy) are eligible. Female subjects of childbearing potential must have a negative serum pregnancy test at enrollment.\n\nAble to understand and voluntarily sign a written informed consent form.\n\nExclusion Criteria:\n\n* Patients meeting any of the following criteria will be excluded from this study:\n\nAny prior treatment for CLL or SLL (including but not limited to chemotherapy, targeted therapy, immunomodulatory therapy, radiotherapy, and\u002For monoclonal antibody therapy).\n\nHistory of other malignancies, unless:\n\n1. The malignancy has been cured with no known active disease for at least 3 years prior to the first dose and is considered by the treating physician to carry a low risk of recurrence.\n2. Adequately treated non-melanoma skin cancer or lentigo maligna with no evidence of disease.\n3. Adequately treated carcinoma in situ with no evidence of disease. Known or suspected history of Richter's transformation. Uncontrolled autoimmune hemolytic anemia or autoimmune thrombocytopenia. Subjects with a decline in hemoglobin level or platelet count due to autoimmune destruction within 4 weeks prior to first dose, or requiring \\> 20 mg prednisone daily (or equivalent) to treat or control autoimmune disease.\n\nUse of \\> 20 mg\u002Fday prednisone within 7 days prior to first dose of study drug (unless used for prophylaxis or treatment of allergic reactions, such as to contrast media).\n\nKnown allergic reaction to any of the study drugs. Known hypersensitivity to xanthine oxidase inhibitors and\u002For rasburicase. Subjects with hypersensitivity to xanthine oxidase inhibitors who cannot receive rasburicase will be excluded.\n\nReceipt of a live attenuated vaccine within 4 weeks prior to first dose of study drug.\n\nActive infection requiring systemic therapy that is ongoing or completed within 14 days prior to first dose, or any uncontrolled active systemic infection.\n\nKnown bleeding disorders (e.g., von Willebrand disease or hemophilia). History of stroke or intracranial hemorrhage within 6 months prior to enrollment.\n\nKnown history of HIV infection, or active hepatitis B virus (HBV) or hepatitis C virus (HCV) infection. Subjects who are positive for HBV core antibody, hepatitis B surface antigen (HBsAg), or HCV antibody must have a negative PCR result prior to enrollment. Subjects with a positive PCR result will be excluded.\n\nMajor surgery within 4 weeks prior to first dose. Any life-threatening illness, medical condition, or organ system dysfunction that, in the investigator's judgment, could compromise the subject's safety or pose an undue risk to the study results.\n\nCurrent active, clinically significant cardiovascular disease, such as uncontrolled arrhythmia, New York Heart Association (NYHA) Class 3 or 4 congestive heart failure, or history of myocardial infarction, unstable angina, or acute coronary syndrome within 6 months.\n\nInability to swallow capsules\u002Ftablets, or presence of malabsorption syndrome, disease significantly affecting gastrointestinal function, history of partial or total gastrectomy or small bowel resection, symptomatic inflammatory bowel disease or ulcerative colitis, or partial or complete bowel obstruction.\n\nConcurrent use of warfarin or other vitamin K antagonists. Requirement for treatment with strong cytochrome P450 (CYP) 3A inhibitors. Current active, clinically significant hepatic impairment meeting Child-Pugh Class B or C criteria.\n\nFemale subjects who are lactating or pregnant. Unwilling or unable to participate in all required study assessments and procedures.\n\nInability to understand the purpose and risks of the study and to provide a signed and dated informed consent form (ICF) and authorization for use of protected health information (in accordance with national and local privacy regulations).","75 Years",{"count":56,"type":20},24,"INTERVENTIONAL",[59],"PHASE2","This study is a prospective, multicenter, open-label, single-arm phase II clinical trial evaluating the efficacy and safety of an MRD-guided, time-limited therapy with zanubrutinib combined with sonrotoclax in previously untreated high-risk CLL\u002FSLL patients.",[28],[63,64],"BCL2i","MRD","2026-06-22",{"date":67,"type":40},"2026-06-26",{"date":69,"type":40},"2026-06-01",{"date":71,"type":20},"2030-12-31",{"name":73,"class":74},"The First Affiliated Hospital with Nanjing Medical University","OTHER",{"id":76,"slug":77,"hasResults":11,"nctId":78,"briefTitle":79,"officialTitle":80,"acronym":81,"eligibilityCriteria":82,"healthyVolunteers":11,"sex":15,"minAge":16,"maxAge":4,"enrollmentInfo":83,"targetDuration":4,"studyType":57,"phases":85,"briefSummary":86,"conditions":87,"keywords":4,"overallStatus":88,"whyStopped":4,"lastUpdateSubmitDate":89,"lastUpdatePostDateStruct":90,"startDateStruct":92,"completionDateStruct":94,"leadSponsor":96,"locationsCount":4},"100641030","phase-2-fixed-duration-treatment-with-combined-pirtobrutinib-and-short-course-immuno-chemotherapy-in-fit-patients-with-previously-untreated-symptomatic-chronic-lymphocytic-leukemia-cll-100641030","NCT07624799","Fixed Duration Treatment With Combined Pirtobrutinib and Short Course Immuno-chemotherapy in Fit Patients With Previously Untreated Symptomatic Chronic Lymphocytic Leukemia (CLL).","Fixed Duration Treatment With Combined Pirtobrutinib and Short Course Immuno-chemotherapy in Fit Patients With Previously Untreated Symptomatic Chronic Lymphocytic Leukemia (CLL). A Phase II FILO Trial","PACIFIC","Inclusion Criteria:\n\n* Immunophenotypically confirmed CLL according to IWCLL 2018 guidelines\n* Binet stage C or Binet stage A and B with active disease could be considered for inclusion according to IWCLL 20108 for initiation of treatment.\n* Absence of Del(17p) and TP53 mutation in NGS (cut off 1%)\n* ECOG performance status 0-2\n* CIRS (Cumulative Illness Rating Scale) ≤ 6\n* Adequate coagulation: defined as activated partial thromboplastin time (aPTT) or partial thromboplastin time (PTT) and prothrombin (PT) or (international normalized ratio (INR) not greater than 1.5 x ULN\n* Calculated creatinine clearance ≥ 30 ml\u002Fmin according to Cockcroft\u002FGault Formula: (140 - age) × body weight (kg) × 0.85 (if female) serum creatinine (mg\u002FdL) × 72\n* Adequate liver function:\n* Aspartate aminotransferase (AST)\u002Falanine aminotransferase or (ALT) ≤ 3 × the ULN or ≤ 5 × ULN with documented liver involvement,\n* Total bilirubin ≤ 1.5 × ULN or ≤ 3 × ULN with documented liver involvement and\u002For Gilbert's Disease\"\n* Adequate hematology values:\n* absolute neutrophil count ≥ 0.75 x 109\u002FL,\n* platelet count ≥ 50 x 109\u002FL (accordance to the coordinator if linked to the disease),\n* Hemoglobin ≥ 80g\u002FL Notes: Hgb and platelets: independent of transfusions within 7 days of Screening assessment. ANC: independent of growth factor support within 7 days of Screening assessment. Criteria must be met on C1D1 without transfusion\u002FG-CSF within 7 days of assessment\n* Prior vaccination to the SARS-Cov-2 virus and SARS-CoV-2 PCR testing (if clinically indicated) and negative result before study treatment administration at each treatment cycle\n* The patient is able to take oral medications\n* Signed written informed consent\n* Willing or able to participate in all required study evaluations and procedures.\n* Ability to understand the purpose and risks of the study and to provide a signed and dated informed consent form and authorization to use protected health information (in accordance with national and local subject privacy regulations)\n\nExclusion Criteria:\n\n1. Presence of Clonal hematopoiesis of indetermined potential or CHIP (To define patients with CHIP: Presence of a myeloid mutation (whatever the mutation) with a VAF \\>2% in the granular fraction\n2. Binet stage A without active disease according to IWCLL 20108 criteria\n3. Life expectancy \\\u003C 6 months\n4. Current or past history or presence of clinically relevant disorder affecting the central nervous system (CNS)\n5. Patient with history of confirmed progressive multifocal leukoencephalopathy (PML)\n6. Evidence of other clinically significant uncontrolled condition(s) including, but not limited to:\n\n   \\- Uncontrolled and\u002For active systemic infection (viral, bacterial or fungal): Known history of human immunodeficiency virus, serologic status reflecting active hepatitis B virus or hepatitis C virus infection, any uncontrolled active systemic infection along with subjects who are ongoing anti-infective treatment and subjects who have received vaccination with a live attenuated vaccine within 4 weeks before the first dose of study treatment\n   1. Subjects who are hepatitis B core antibody (anti-HBc) positive and who are hepatitis B surface antibody (anti-HBs) negative will need to have a negative hepatitis B virus PCR result before enrollment. Those who are hepatitis B surface antigen (HBsAg) positive or hepatitis B virus PCR positive will be excluded.\n   2. Subjects who are hepatitis C virus antibody positive will need to have a negative hepatitis C virus PCR result before enrollment. Those who are hepatitis C virus PCR positive will be excluded\n\n      * Known active cytomegalovirus (CMV) infection. Unknown or negative status are eligible.\n      * Active and uncontrolled autoimmune cytopenia, including autoimmune hemolytic anemia (AIHA) (isolated positive DAT is not an exclusion criteria) and idiopathic thrombocytopenic purpura (ITP).\n7. Concomitant disease requiring prolonged use of corticosteroids (\\> 1 month)\n8. Patients treated by vitamin K antagonist or dual antiaggregant or anticoagulants (coumadin, warfarin)\n9. History of bleeding diathesis (e.g. hemophilia or von Willebrand disease)\n10. Prior solid organ transplantation\n11. Concurrent severe diseases that exclude the administration of therapy :\n\n    * Heart insufficiency NYHA grade III\u002FIV, LEVF LVEF \\\u003C 50% and or RF \\\u003C 30%, myocardial infarction within the past 6 months prior to study\n    * Significant cardiovascular disease such as symptomatic arrhythmias (including atrial fibrillation), congestive heart failure, unstable angina or acute coronary syndrome within the past 2 months prior to randomization 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 (Subjects with controlled, asymptomatic atrial fibrillation are allowed to enroll on study)\n    * Prolongation of the QT interval corrected for heart rate (QTcF) \\> 470 msec. QTcF is calculated using Fridericia's Formula (QTcF): QTcF = QT\u002F(RR0.33).\n\n      * 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.\n      * Correction for underlying bundle branch block (BBB) allowed\n    * Severe chronic obstructive lung disease with hypoxemia\n    * History of stroke or intra-cranial hemorrhage within the last 6 months\n    * Severe diabetes mellitus\n    * Uncontrolled hypertension\n    * Impaired renal function with creatinine clearance \\\u003C 30 ml\u002Fmin according the formula of Cockroft and Gault\n12. Patient who requires treatment with proton-pump inhibitors (e.g., omeprazole, esomeprazole, lansoprazole, dexlansoprazole, rabeprazole, or pantoprazole (unless of separate dosing of pirtobrutinib capsules with antacids by at least 2 hours. Pirtobrutinib capsules should be taken 2 hours before an H2-receptor antagonist. Avoid co-administration of pirtobrutinib capsules with proton pump inhibitors).\n13. Disease significantly affecting gastrointestinal function (malabsorption syndrome, stomach or small bowel resection)\n14. Evidence for Richter syndrome\n15. Treatment with any of the following within 7 days prior to the first dose of study drug: steroid therapy (see criteria 7 above) for anti-neoplastic intent.\n16. A significant history of renal, neurologic, psychiatric, endocrine, metabolic, immunologic, cardiovascular, or hepatic disease that, in the investigator's opinion, would adversely affect the patient's participation in this study or interpretation of study outcomes.\n17. Major surgery within 30 days prior to the first dose of study treatment.\n18. History of prior other malignancy that could affect compliance with the protocol or interpretation of results, with the exception of the following:\n\n    * Curatively treated basal cell carcinoma or squamous cell carcinoma of the skin or carcinoma in situ of the cervix at any time prior to study.\n    * Other cancers not specified above that have been curatively treated by surgery and\u002For radiation therapy from which patient is disease-free for ≥ 5 years without further treatment.\n19. Have a known hypersensitivity to any of the excipients of pirtobrutinib or to any intended study medications.\n20. Persons deprived of their liberty by judicial or administrative decision, persons subject to a legal protection measure (guardianship, curatorship, legal protection), persons under psychiatric care\n21. Treatment with another investigational agent or participating in another trial within 30 days prior to entering the study\n22. No affiliate to social security\n23. Currently pregnant (confirmed with positive pregnancy test) or breast feeding.\n24. Women of Childbearing Potential (WOCBP) unless the following criteria are met- a negative pregnancy test is required for all WOCBP within 21 days before start of study intervention, followed by immediate highly effective contraception; further pregnancy testing will be performed monthly.\n25. Fertile men or WOCBP unless the following criteria are met:\n\n    Willing to use 2 methods of reliable contraception, including one highly effective contraceptive method (Pearl Index \\\u003C 1) and one additional effective (barrier) method during study intervention and for 1 month after last pirtobrutinib dose (for WOCBP). Men must refrain from sperm donation during the study.\n26. Fertile male and female patients who cannot or do not wish to use an effective method of contraception, during and for 12 months after the final treatment used for the purposes of the study.\n27. Lactation or plan to breastfeed during the study or within 1 week of the last dose of study treatment.",{"count":84,"type":20},82,[59],"The evidence base in support of fixed-duration, first-line approaches in medically fit patients with CLL is clearly strengthening, whether through combining targeted agents with immunochemotherapy or through chemotherapy-free combinations. The long-term PB MRD response rates with the investagators fixed-duration (15-month) immunochemotherapy approach remain the best to date, even compared to the new targeted agent combinations of ibrutinib-venetoclax or obinutuzumab-venetoclax.\n\nThe investigators' phase 2 ICLL07 trial in previously untreated fit CLL patients with a fixed-duration immunochemotherapy approach (with 4 cycles of FC-obinutuzumab and chemosparing strategy) carries a low risk for short and long term toxicities which still exist, including cardiac toxicities probably related to BTK inhibitors, moreover, two patients experienced treatment related myelodysplastic syndrome or acute myeloid leukemia beyond the end of treatment. Follow-up at 5,5 years from treatment start showed a persistent PB MRD benefit beyond end of treatment, high survival rates, and low long term toxicity with no difference in the durability of MRD response between the mutated and unmutated IGHV patients.\n\nThe investigators aim to explore the safety and efficacy of a fixed duration strategy combining a new BTK inhibitor with a favorable safety profile and a limited number of ICT courses.\n\nThe main goals and concerns are:\n\ni) to ensure deep response and long lasting MRD ii) to reduce the duration of BTKi exposure and the risk of clonal evolution with the appearance of deleterious mutations iii) to limit the risk of hematopoietic secondary cancers (MDS\u002FAML) by excluding patients in whom clonal hematopoiesis of undetermined potential (CHIP) is detected before inclusion and decreasing the number of courses of chemotherapy to 3 cycles. Moreover, patients with TP53 abnormalities will be excluded with a lower cut off (1% versus 10% in the previous studies) iv) to limit the risk of BTKi toxicity by using a non-covalent BTKi",[28],"NOT_YET_RECRUITING","2026-05-29",{"date":91,"type":40},"2026-06-03",{"date":93,"type":20},"2026-09-01",{"date":95,"type":20},"2033-09-01",{"name":97,"class":74},"French Innovative Leukemia Organisation",{"id":99,"slug":100,"hasResults":11,"nctId":101,"briefTitle":102,"officialTitle":103,"acronym":4,"eligibilityCriteria":104,"healthyVolunteers":11,"sex":15,"minAge":16,"maxAge":4,"enrollmentInfo":105,"targetDuration":4,"studyType":57,"phases":107,"briefSummary":109,"conditions":110,"keywords":118,"overallStatus":36,"whyStopped":4,"lastUpdateSubmitDate":149,"lastUpdatePostDateStruct":150,"startDateStruct":152,"completionDateStruct":154,"leadSponsor":156,"locationsCount":159},"100619273","phase-3-rocket-cll-global-phase-3-study-rocbrutinib-vs-pirtobrutinib-in-cbtki-pretreated-rr-cllsll-100619273","NCT07342478","ROCKET-CLL Global Phase 3 Study: Rocbrutinib vs Pirtobrutinib in cBTKi-Pretreated R\u002FR CLL\u002FSLL","A Phase 3 Open-Label, Randomized, Multicenter Study of Rocbrutinib (LP-168) vs Pirtobrutinib in Covalent BTK Inhibitor (cBTKi) Pretreated Relapsed or Refractory Chronic Lymphocytic Leukemia (CLL) \u002F Small Lymphocytic Lymphoma (SLL) Subjects","Inclusion Criteria:\n\n* Age ≥18 years;\n* Histologically confirmed CLL\u002FSLL iwCLL 2018;\n* Relapsed or refractory disease requiring treatment;\n* Previously treated with prior lines of therapy including a covalent BTK inhibitor;\n* Measurable disease;\n* ECOG 0-2;\n* Adequate marrow, hepatic, and renal function;\n* TP53 mutation status confirmed by NGS;\n* 17p deletion status confirmed by FISH;\n\nExclusion Criteria:\n\n* Prior ncBTKi or BTK degraders;\n* Richter's transformation;\n* Confirmed prolymphocytic leukemia;\n* Uncontrolled comorbidities or infections;\n* Known CNS involvement by CLL\u002FSLL;\n* Prior malignancy requiring active treatment (except certain adequately treated cancers) per protocol;\n* Pregnancy or breastfeeding;\n* Concomitant medications or conditions prohibited by protocol (e.g., strong drug-drug interaction risk);",{"count":106,"type":20},306,[108],"PHASE3","This is a Phase 3, randomized, open-label, multicenter study comparing rocbrutinib (LP-168) versus pirtobrutinib in adult participants with relapsed or refractory chronic lymphocytic leukemia (CLL) or small lymphocytic lymphoma (SLL) who have previously received a covalent Bruton's tyrosine kinase inhibitor (cBTKi). Approximately 306 participants will be randomized 1:1 to receive rocbrutinib 200 mg orally once daily or pirtobrutinib 200 mg orally once daily, administered continuously in 28-day cycles until disease progression, unacceptable toxicity, withdrawal of consent, or other discontinuation criteria are met. Randomization will be stratified by presence of del(17p)\u002FTP53 mutation (yes\u002Fno), reason for discontinuation of prior cBTKi therapy (toxicity vs disease progression), prior exposure to a BCL2 inhibitor (yes\u002Fno), and region (United States\u002FChina\u002Frest of world). The primary endpoint is progression-free survival (PFS) assessed by an independent review committee (IRC) using iwCLL 2018 criteria for CLL and Lugano 2014 criteria for SLL. Key secondary objectives include overall survival, overall response rate, time-to-event outcomes, and safety\u002Ftolerability; exploratory objectives include health-related quality of life and biomarker assessments.",[111,28,112,113,114,115,116,117],"CLL \u002F SLL","CLL, Refractory","CLL, Relapsed","SLL (Small Lymphocytic Lymphoma)","SLL","CLL","CLL Progression",[119,120,121,122,123,124,125,126,116,115,127,128,129,130,131,132,133,134,135,136,137,138,139,140,141,142,143,144,145,146,147,148],"Rocbrutinib","LP-168","Pirtobrutinib","Jaypirca","Phase 3","Randomized","Open-label","Relapsed or refractory","CLL\u002FSLL","Chronic lymphocytic leukemia","Small lymphocytic lymphoma","Covalent BTK inhibitor pretreated","cBTKi pretreated \u002F cBTKi-exposed","BTK inhibitor","Non-covalent BTK inhibitor","Next-generation BTKi","Dual-binding BTKi","Fourth-generation BTKi","Oral once daily","Progression-free survival","PFS","Independent review committee","IRC-assessed","iwCLL 2018","Lugano 2014","del(17p)","TP53 mutation","Prior BCL2 inhibitor exposure","eason for prior BTKi discontinuation (progression vs intolerance)","Global","2026-05-12",{"date":151,"type":40},"2026-05-14",{"date":153,"type":40},"2026-04-23",{"date":155,"type":20},"2030-07-30",{"name":157,"class":158},"Newave Pharmaceutical Inc","INDUSTRY",4,{"id":161,"slug":162,"hasResults":11,"nctId":163,"briefTitle":164,"officialTitle":165,"acronym":166,"eligibilityCriteria":167,"healthyVolunteers":11,"sex":15,"minAge":16,"maxAge":4,"enrollmentInfo":168,"targetDuration":4,"studyType":57,"phases":170,"briefSummary":172,"conditions":173,"keywords":174,"overallStatus":36,"whyStopped":4,"lastUpdateSubmitDate":178,"lastUpdatePostDateStruct":179,"startDateStruct":181,"completionDateStruct":183,"leadSponsor":185,"locationsCount":46},"100630419","cll-impact-a-clinical-nutrition-trial-investigating-immune-and-metabolic-changes-in-early-stage-cll-100630419","NCT07487428","CLL-IMPACT: A Clinical Nutrition Trial Investigating Immune and Metabolic Changes in Early-Stage CLL","An Interventional Study of Dietary Effects on Immune Function, Metabolism and Disease Activity in Early-Stage Chronic Lymphocytic Leukemia","CLL-IMPACT","Inclusion Criteria:\n\n* Confirmed CLL diagnosis\n* No previous treatments (watch and wait)\n* Willingness to comply to a whole-food plant-based diet for 4 weeks\n* Willingness to participate in a total of 3 blood drawings\n\nExclusion Criteria:\n\n* Emergency interventions\n* Patients that already follow a WFPB or vegan diet\n* Progression of CLL that implicates need for treatment\n* Insulin-dependent diabetes\n* Taking lipid-lowering medications (e.g. statins)\n* Body mass index (BMI) \\\u003C20 And if in the opinion of the investigator there are any concerns regarding the ability of the patient to complete the study safely.",{"count":169,"type":20},50,[171],"NA","The goal of this clinical trial is to investigate whether a short-term (4-week) whole-food, plant-based (WFPB) diet has an effect on metabolism, immune function, and disease activity in early-stage chronic lymphocytic leukemia (CLL). The main questions the study aims to answer are:\n\n* Does a WFPB diet influence disease progression?\n* How do CLL cells and other immune cell types respond to a WFPB diet in terms of metabolism and signaling?\n\nResearchers will examine whether a WFPB diet can affect absolute lymphocyte counts in participants' blood and what metabolic or functional changes occur within the CLL cells.\n\nParticipants will:\n\n* Switch to a WFPB diet for 4 weeks following an introductory session with a certified dietary instructor.\n* Visit the clinic before starting the diet and again after 14 and 28 days for blood draws and to provide stool samples.\n* Keep a diary of all foods and drinks consumed during the week prior to and throughout the study period.",[28],[175,176,177],"Diet","Nutrition","Plant-based diet","2026-03-17",{"date":180,"type":40},"2026-03-23",{"date":182,"type":40},"2024-01-01",{"date":184,"type":20},"2028-06-30",{"name":186,"class":74},"Technical University of Munich",{"id":188,"slug":189,"hasResults":11,"nctId":190,"briefTitle":191,"officialTitle":191,"acronym":192,"eligibilityCriteria":193,"healthyVolunteers":11,"sex":15,"minAge":16,"maxAge":194,"enrollmentInfo":195,"targetDuration":4,"studyType":57,"phases":197,"briefSummary":198,"conditions":199,"keywords":209,"overallStatus":36,"whyStopped":4,"lastUpdateSubmitDate":212,"lastUpdatePostDateStruct":213,"startDateStruct":214,"completionDateStruct":216,"leadSponsor":218,"locationsCount":221},"100582139","phase-2-a-platform-protocol-to-investigate-post-transplant-cyclophosphamide-based-graft-versus-host-disease-prophylaxis-in-patients-with-hematologic-malignancies-undergoing-mismatched-unrelated-donor-peripheral-blood-stem-cell-transplantation-100582139","NCT06859424","A Platform Protocol to Investigate Post-Transplant Cyclophosphamide-Based Graft-Versus-Host Disease Prophylaxis in Patients With Hematologic Malignancies Undergoing Mismatched Unrelated Donor Peripheral Blood Stem Cell Transplantation","ACCELERATE","Inclusion Criteria, MAC RECIPIENTS:\n\n1. Age 18 to \\\u003C 66 years (chemotherapy-based conditioning) or \\\u003C 61 years (TBI-based conditioning) at the time of signing informed consent\n2. Patient or legally authorized representative has the ability to provide informed consent according to the applicable regulatory and institutional requirements\n3. Stated willingness to comply with all study procedures and availability for the duration of the study\n4. Planned MAC regimen (see Table 8 in Section 7.4 for allowed MAC regimens)\n5. Available partially HLA-MMUD (4\u002F8-7\u002F8 at HLA-A, -B, -C, and -DRB1 is required) with age 16-35\n6. Product planned for infusion is MMUD T-cell replete PBSC as allograft\n7. HCT-CI \\\u003C 5 (Appendix H - Hematopoietic Cell Transplant Comorbidity Index Scoring). The presence of prior malignancy will not be used to calculate HCT-CI for this trial, to allow for the inclusion of patients with secondary or therapy-related AML or MDS.\n8. One of the following diagnoses:\n\n   1. AML, ALL, or other acute leukemia in first remission or beyond with ≤ 5% marrow blasts and no circulating blasts or evidence of extramedullary disease. Documentation of bone marrow assessment will be accepted within 45 days prior to the anticipated start of conditioning.\n   2. Patients with MDS with no circulating blasts and with \\\u003C 10% blasts in the bone marrow (higher blast percentage allowed in MDS due to lack of differences in outcomes with \\\u003C 5% vs 5-10% blasts in MDS). Documentation of bone marrow assessment will be accepted within 45 days prior to the anticipated start of conditioning.\n9. Cardiac function: Left ventricular ejection fraction ≥ 45% based on most recent echocardiogram or multi-gated acquisition scan (MUGA) results\n10. Estimated creatinine clearance ≥ 45mL\u002Fmin calculated by equation\n11. Pulmonary function: diffusing capacity of the lungs for carbon monoxide (DLCO) corrected for hemoglobin ≥ 50% and forced expiratory volume in first second (FEV1) predicted ≥ 50% based on most recent PFT results\n12. Liver function acceptable per local institutional guidelines\n13. KPS of ≥ 70% (Appendix I - Performance Status)\n\nInclusion Criteria, RIC\u002FNMA RECIPIENTS:\n\n1. Age ≥ 18 years at the time of signing informed consent\n2. Patient or legally authorized representative has the ability to provide informed consent according to the applicable regulatory and local institutional requirements\n3. Stated willingness to comply with all study procedures and availability for the duration of the study\n4. Planned NMA\u002FRIC regimen (see\n5. Table 9 in Section 7.4 for allowed NMA\u002FRIC regimens)\n6. Available partially HLA-MMUD (4\u002F8-7\u002F8 at HLA-A, -B, -C, and -DRB1 is required) with age 16-35\n7. Product planned for infusion is MMUD T-cell replete PBSC allograft\n8. One of the following diagnoses:\n\n   1. Patients with acute leukemia or chronic myeloid leukemia (CML) with no circulating blasts, no evidence of extramedullary disease, and with \\\u003C 5% blasts in the bone marrow. Documentation of bone marrow assessment will be accepted within 45 days prior to the anticipated start of conditioning.\n   2. Patients with MDS with no circulating blasts and with \\\u003C 10% blasts in the bone marrow (higher blast percentage allowed in MDS due to lack of differences in outcomes with \\\u003C 5% vs 5-10% blasts in MDS.) Documentation of bone marrow assessment will be accepted within 45 days prior to the anticipated start of conditioning.\n   3. Patients with chronic lymphocytic leukemia (CLL) or other leukemias (including prolymphocytic leukemia) with chemosensitive disease at time of transplantation.\n   4. Higher-risk chronic myelomonocytic leukemia (CMML) according to CMML-specific prognostic scoring system or high-risk MDS\u002Fmyeloproliferative neoplasms (MPN) not otherwise specified are eligible, provided there is no evidence of high-grade bone marrow fibrosis or massive splenomegaly at the time of enrollment.\n   5. Patients with lymphoma with chemosensitive disease at the time of transplantation.\n   6. Patients with primary myelofibrosis or myelofibrosis secondary to essential thrombocythemia, polycythemia vera or MDS with grade 4 fibrosis.\n9. Cardiac function: Left ventricular ejection fraction ≥ 40% based on most recent echocardiogram or MUGA results with no clinical evidence of heart failure\n10. Estimated creatinine clearance ≥ 45mL\u002Fmin calculated by equation\n11. Pulmonary function: DLCO corrected for hemoglobin ≥ 50% and FEV1 predicted ≥ 50% based on most recent PFT results\n12. Liver function acceptable per local institutional guidelines\n13. KPS of ≥ 60% (Appendix I - Performance Status)\n\nExclusion Criteria:\n\n1. Suitable HLA-matched related or 8\u002F8 high-resolution matched unrelated donor available\n2. Subject unwilling or unable to give informed consent, or unable to comply with the protocol including required follow-up and testing\n3. Subjects with a prior allogeneic transplant\n4. Subjects with an autologous transplant within the past 3 months\n5. Subjects who are breastfeeding or pregnant\n6. Uncontrolled bacterial, viral or fungal infection at the time of the transplant preparative regimen\n7. Concurrent enrollment on a GVHD prevention clinical trial\n8. Subjects who undergo desensitization to reduce anti-donor HLA antibody levels prior to transplant\n9. Patients who are HIV-positive with persistently positive viral load. HIV-infected patients on effective anti-retroviral therapy (ART) with undetectable viral load within 6 months are eligible for this trial. Patients with well-controlled HIV are eligible provided resistance panels are negative, the patient is compliant with ART, and their disease remains well controlled.","66 Years",{"count":196,"type":20},358,[59],"The purpose of this clinical trial is to compare drug combinations to learn which drugs work best to prevent graft-versus-host-disease (GVHD) in people who have received a stem cell transplant. The source of stem cells is from someone who is not related and has a different blood cell type than the study participant. The researchers will compare the new drug combination to a standard drug combination. They will also learn about the safety of each drug combination.\n\nParticipants will:\n\n* Receive the standard or new drug combination after transplant\n* Visit the doctor's office for check-ups and tests after transplant that are routine for most transplant patients\n* Take surveys about physical and emotional well-being\n* Give blood and stool samples.",[200,201,202,203,204,28,205,206,207,35,208],"AML (Acute Myelogenous Leukemia)","Acute Lymphoid Leukemia (ALL)","Acute Leukemia (Category)","MDS (Myelodysplastic Syndrome)","CML (Chronic Myelogenous Leukemia)","Prolymphocyctic Leukemia","Chronic Myelomonocytic Leukemia (CMML)","Myeloproliferative Neoplasm (MPN)","Myelofibrosis",[192,210,211],"ACCEL-001","ACCEL-002","2026-03-16",{"date":178,"type":40},{"date":215,"type":40},"2025-07-25",{"date":217,"type":20},"2028-06",{"name":219,"class":220},"Center for International Blood and Marrow Transplant Research","NETWORK",13,{"id":223,"slug":224,"hasResults":11,"nctId":225,"briefTitle":226,"officialTitle":226,"acronym":4,"eligibilityCriteria":227,"healthyVolunteers":11,"sex":15,"minAge":16,"maxAge":54,"enrollmentInfo":228,"targetDuration":4,"studyType":57,"phases":230,"briefSummary":232,"conditions":233,"keywords":243,"overallStatus":36,"whyStopped":4,"lastUpdateSubmitDate":251,"lastUpdatePostDateStruct":252,"startDateStruct":254,"completionDateStruct":256,"leadSponsor":258,"locationsCount":5},"100484580","phase-1-a-first-in-human-study-of-hla-partially-to-fully-matched-allogenic-cryopreserved-deceased-donor-bone-marrow-transplantation-for-patients-with-hematologic-malignancies-100484580","NCT05589896","A First-in-Human Study of HLA-Partially to Fully Matched Allogenic Cryopreserved Deceased Donor Bone Marrow Transplantation for Patients With Hematologic Malignancies","Inclusion Criteria:\n\n* Patient has the ability to provide informed consent according to the applicable regulatory and local institutional requirements\n* Male or female, aged ≥18 and ≤65 years for patients receiving MAC (Regimen A or Regimen B); aged ≥18 and ≤75 years for patients receiving RIC (Regimen C or D)\n* Patient must require allogeneic HCT per the discretion of the treating physician\n* Patient must be high-resolution, HLA partially or fully matched (4-8\u002F8 allele matched at HLA-A, -B, -C, DRB1) to an available Ossium HPC, Marrow product\n* Stated willingness to comply with all study procedures and availability for the duration of the study\n* Diagnosed with malignant hematologic disease including:\n\n  1. Acute leukemia \\[acute lymphoblastic leukemia (ALL), acute myeloid leukemia (AML), acute biophenotypic leukemia (ABL), or acute undifferentiated leukemia (AUL)\\], MDS without fibrosis, or chronic leukemia (CLL, CML) in the first remission or beyond with ≤5% marrow blasts documented by bone marrow assessment and no circulating blasts or extra-medullary disease within 42 days prior to anticipated start of conditioning\n  2. Chemosensitive non-Hodgkin's lymphomas, Hodgkin's lymphoma, or cutaneous T cell lymphomas in the first remission or beyond documented by PET\u002FCT imaging and bone marrow assessment within 42 days prior to anticipated start of conditioning\n* Karnofsky performance status score ≥70% (MAC) or ≥60% (RIC)\n* HCT comorbidity index (HCT-CI) ≤5\n* Adequate organ function defined as:\n\n  1. Cardiac: LVEF at rest ≥40% (RIC) or LVEF at rest ≥45% (MAC)\n  2. Pulmonary: DLCO, FEV1, FVC ≥50% predicted by pulmonary function tests (PFTs). DLCO value may be corrected for hemoglobin.\n  3. Hepatic: total bilirubin ≤2.0 mg\u002FdL, and ALT, AST, and ALP \\\u003C3 x upper limit normal (ULN), unless ALT, AST, and\u002For ALP are disease related\n  4. Renal: SCr within 1.5x normal range for age. If SCr is outside normal range for age, CrCl\\> 60 mL\u002Fmin\u002F1.73m2 must be obtained (measured by 24-hour urine specimen or nuclear glomerular filtration rate (GFR), or calculated GFR)\n\nExclusion Criteria:\n\n* Availability of suitable graft from living donor (defined as 7\u002F8 or 8\u002F8 HLA-matched related or unrelated donors, haploidentical donors, or cord blood donors)\n* Prior autologous or allogeneic HCT\n* Pregnancy or lactation\n* Ongoing treatment with an investigational drug used for disease-related treatment within 5 half-lives of the drug\n* Current uncontrolled bacterial, viral or fungal infection defined as currently taking medication with evidence of progression of clinical symptoms or radiologic findings\n* Any condition(s) or diagnosis, both physical or psychological, or physical exam finding that in the investigator's opinion precludes participation",{"count":229,"type":20},12,[231,59],"PHASE1","The goal of this clinical trial is to determine the safety and feasibility of allogeneic transplantation with bone marrow from a deceased donor in patients with acute and chronic leukemias, myelodysplastic syndrome, and certain lymphomas. Patients will either receive myeloablative conditioning or reduced intensity conditioning regimen prior to the transplant. Patients will be followed for 56 days for safety endpoints and remain in follow-up for one year.",[234,235,236,237,238,28,239,203,240,241,242],"Acute Leukemia","Acute Lymphoblastic Leukemia","Acute Myeloid Leukemia","Acute Biphenotypic Leukemia","Acute Undifferentiated Leukemia","Chronic Myeloid Leukemia (CML)","Non-Hodgkin Lymphomas","Hodgkins Lymphoma","Cutaneous T Cell Lymphomas (CTCL)",[34,244,15,245,246,247,248,35,249,116,250],"Hematologic Diseases","AML","ABL","AUL","Bone Marrow Transplant","MDS","CML","2026-02-20",{"date":253,"type":40},"2026-02-24",{"date":255,"type":40},"2024-08-16",{"date":257,"type":20},"2027-03-31",{"name":259,"class":158},"Ossium Health, Inc.",{"id":261,"slug":262,"hasResults":11,"nctId":263,"briefTitle":264,"officialTitle":265,"acronym":4,"eligibilityCriteria":266,"healthyVolunteers":11,"sex":15,"minAge":16,"maxAge":4,"enrollmentInfo":267,"targetDuration":4,"studyType":57,"phases":269,"briefSummary":270,"conditions":271,"keywords":4,"overallStatus":36,"whyStopped":4,"lastUpdateSubmitDate":272,"lastUpdatePostDateStruct":273,"startDateStruct":275,"completionDateStruct":277,"leadSponsor":279,"locationsCount":159},"100570565","phase-1-a-phase-1-study-of-ze50-0134-in-relapsed-and-refractory-chronic-lymphocytic-leukemia-small-lymphocytic-lymphoma-and-select-low-grad-lymphomas-100570565","NCT06708897","A Phase 1 Study of ZE50-0134 in Relapsed and Refractory Chronic Lymphocytic Leukemia, Small Lymphocytic Lymphoma, and Select Low-grad Lymphomas","Phase 1 Study of ZE50-0134 in Relapsed and Refractory Chronic Lymphocytic Leukemia (CLL), Small Lymphocytic Lymphoma (SLL), and Select Low-grade Lymphomas","Inclusion Criteria:\n\n1. Men and women aged ≥18 years.\n2. Disease as defined below:\n\n   Part 1: Patients with symptomatic CLL or SLL (defined by iwCLL) without del(17p)\u002FTP53 must have received ≥2 prior therapies that have included a BTKi and venetoclax (or declined this) or Patients with progressive low-grade lymphoma that includes marginal zone lymphoma, lymphoplasmacytic lymphoma (including Waldenstrom's macroglobulinemia) who have received at least 2 therapies including a BTKi and CD20 antibody-based therapy.\n\n   Part 2: Patients with symptomatic CLL or SLL (defined by iwCLL) must have received ≥1 prior therapies that have included a BTKi and be venetoclax naive.\n3. Prior to beginning part 2, an activation amendment will be submitted to the FDA that includes safety, pharmacokinetics, pharmacodynamics and early efficacy data from the Part 1 portion. At this time, we may also include cohorts of specific types of low-grade lymphoma as well. Adequate bone marrow, liver, and renal functions as assessed by the following laboratory requirements to be conducted within 7 days before the first dose of study drug:\n\n   * Absolute neutrophil count (ANC) \\> 0.75 x 109\u002FL. For subjects with documented bone marrow involvement ≥ 0.5 x 109\u002FL\n   * Platelet count \\> 50 x 109\u002FL. For subjects with documented bone marrow involvement ≥ 30 x 109\u002FL\n   * Serum aspartate transaminase (AST\u002FSGOT) or alanine transaminase (ALT\u002FSGPT) ≤ 3.0 x upper limit of normal (ULN)\n   * Total bilirubin ≤ 1.5 x ULN\n   * Creatinine or Cystatin C glomerular filtration rate (GFR) ≥60 mL\u002Fmin. Estimated GFR (eGFR) according to the Modification of Diet in Renal Disease Study Group (MDRD) formula and expressed in mL\u002Fmin. To convert mL\u002Fmin\u002F1.73 m2 to mL\u002Fmin multiply by the individual's BSA calculated using an appropriate formula and divide by 1.73 Eastern Cooperative Oncology Group (ECOG) performance status of 2 or less Negative serum or urine pregnancy test must be obtained within 7 days before the first dose of study drug in women of childbearing potential. Negative results must also be available before each cycle.\n\nPostmenopausal women, as defined below, are exempt from pregnancy testing:\n\n* Age \\>50 years with amenorrhea for at least 12 months or\n* Age ≤50 years with 6 months of spontaneous amenorrhea and follicle stimulating hormone (FSH) level within postmenopausal range (\\>40 mIU\u002FmL) OR\n* Permanently sterilized women (e.g., hysterectomy, bilateral salpingectomy, or uterine ablation) Women and men of reproductive potential must agree to use highly effective contraception when sexually active. This applies for the period between signing of the informed consent and 90 days after the last administration of study drug. These methods should be documented in source documents. The investigator or a designated associate is requested to advise the subject on how to achieve highly effective birth control. Ability to understand and the willingness to sign a written informed consent. A signed informed consent (including consent for genetic biomarker\n\nExclusion Criteria:\n\nSubjects will be excluded from the study if they display any of the following criteria:\n\n1. FOR PART 2 ONLY\n\n   \\- No prior venetoclax treatment\n\n   FOR BOTH PARTS ALL THE FOLLOWING APPLY:\n2. Know active Richter's transformation. Patients who have been treated for this diagnosis and have been in remission for \\> 2 years without evidence of this and who have only CLL are considered eligible\n3. Known hypersensitivity to the study drug or excipients of the preparation or any agent given in association with this study.\n4. Clinically significant cardiac disease including congestive heart failure \\> New York Heart Association (NYHA) Class II, evidence for uncontrolled coronary artery disease (e.g., unstable angina (anginal symptoms at rest) or new-onset angina (within the last 6 months or myocardial infarction within the past 6 months before first dose, major regional wall motion abnormalities upon baseline echocardiography), and cardiac arrhythmias requiring anti- arrhythmic therapy except for beta-blockers and digoxin.\n5. Known Active cytomegalovirus (CMV), hepatitis B or C virus infection.\n6. Known Active SARS-CoV-2 infection; prior SARS-CoV-2 infection allowed if completely recovered \\> 14 days.\n7. Active clinically serious infections of Grade \\>2, requiring parenteral therapy; Subjects may be eligible after infection resolves.\n8. Uncontrolled autoimmune hemolytic anemia or idiopathic thrombocytopenic purpura within 28 days of enrolment.\n9. Allogeneic bone marrow transplant within 4 months before first dose of study drug (Subjects must have completed immunosuppressive therapy before enrollment).\n10. Active cancer that limits expected survival to \\\u003C 2 years or requires active therapy concomitant with this treatment. Exclusions would be localized skin cancer, breast cancer, prostate cancer that are resected or malignancies treated with hormonal or immune therapies alone. All cases of secondary cancer should be discussed with the medical monitor.\n11. A physical exam or laboratory finding that contraindicates the use of investigational therapy or otherwise places the subject at excessively high risk for treatment, as determined by the investigator. A discussion between the investigator and sponsor regarding eligibility is encouraged for such cases.\n12. Unresolved toxicity of previous treatments (excluding cases of alopecia) Grade ≥2.\n13. Requires ongoing immunosuppressive therapy, including systemic (e.g., intravenous or oral) corticosteroids for the treatment of cancer or other conditions. Note: Subjects may use topical or inhaled corticosteroids or low-dose steroids (≤10 mg of prednisone or equivalent per day) as therapy for comorbid conditions. Short courses of steroids before first dose are allowed for tumor flare.\n14. Major surgery or significant trauma within 4 weeks before the first dose of study drug.\n15. Breastfeeding women: breastfeeding women have to discontinue breastfeeding before onset of and during treatment and should be discontinued for at least 3 months after end of treatment.\n16. Subjects with QTcF \\> 470 msec that cannot be corrected with electrolyte replacement, hydration, or medication modifications.",{"count":268,"type":20},66,[231],"This is a clinical study aiming to evaluate the safety, pharmacokinetics, pharmacodynamics, and preliminary efficacy of ZE50-0134 in relapsed and refractory chronic lymphocytic leukemia, small lymphocytic lymphoma, and select low-grad lymphomas.",[111,28,114],"2025-11-28",{"date":274,"type":40},"2025-12-05",{"date":276,"type":40},"2025-04-08",{"date":278,"type":20},"2028-04",{"name":280,"class":158},"Lomond Therapeutics Holdings, Inc.",{"id":282,"slug":283,"hasResults":11,"nctId":284,"briefTitle":285,"officialTitle":286,"acronym":4,"eligibilityCriteria":287,"healthyVolunteers":11,"sex":15,"minAge":16,"maxAge":4,"enrollmentInfo":288,"targetDuration":4,"studyType":57,"phases":289,"briefSummary":290,"conditions":291,"keywords":4,"overallStatus":88,"whyStopped":4,"lastUpdateSubmitDate":292,"lastUpdatePostDateStruct":293,"startDateStruct":295,"completionDateStruct":297,"leadSponsor":299,"locationsCount":4},"100591334","phase-1-a-phase-ib-study-of-the-selective-pkc--inhibitor-ms-553-in-patients-with-refractory-or-relapsed-cllsll-100591334","NCT06979076","A Phase Ib Study of the Selective PKC-β Inhibitor MS-553 in Patients With Refractory or Relapsed CLL\u002FSLL","A Phase Ib Study of the Selective PKC-β Inhibitor MS-553 in Patients With Refractory or Relapsed Chronic Lymphocytic Leukemia\u002FSmall Lymphocytic Lymphoma","Inclusion Criteria:\n\n1. Age 18 years or older.\n2. Diagnosis of CLL or SLL:\n\n   1. History of histologically documented CLL or SLL that meets iwCLL diagnostic criteria according to the 2018 guidelines, and\n   2. Indication for treatment as defined by the 2018 iwCLL guidelines, or the need for disease reduction prior to allogeneic transplantation.-\n\nExclusion Criteria:\n\n1. Current transformation of CLL\u002FSLL non-Hodgkin lymphoma or Hodgkin lymphoma.\n2. Active and uncontrolled autoimmune cytopenia(s).",{"count":229,"type":20},[231,59],"A Phase Ib Study of the Selective PKC-β Inhibitor MS-553 in Patients with Refractory or Relapsed Chronic Lymphocytic Leukemia\u002FSmall Lymphocytic Lymphoma",[28,114],"2025-09-23",{"date":294,"type":40},"2025-09-29",{"date":296,"type":20},"2026-07",{"date":298,"type":20},"2028-12",{"name":300,"class":158},"MingSight Pharmaceuticals, Inc"]