[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"chronic-lymphocytic-leukaemia\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:chronic-lymphocytic-leukaemia":27},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,4,0,[8,45,71,108],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":4,"eligibilityCriteria":15,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":18,"enrollmentInfo":19,"targetDuration":4,"studyType":22,"phases":23,"briefSummary":25,"conditions":26,"keywords":29,"overallStatus":32,"whyStopped":4,"lastUpdateSubmitDate":33,"lastUpdatePostDateStruct":34,"startDateStruct":37,"completionDateStruct":39,"leadSponsor":41,"locationsCount":44},"100566191","phase-4-acalabrutinib-monotherapy-vs-investigators-choice-of-treatment-in-patients-with-cl-leukaemia-and-heart-failure-100566191",false,"NCT06651970","Acalabrutinib Monotherapy vs Investigator's Choice of Treatment in Patients With CL Leukaemia and Heart Failure","A Multicentre, Open-label, Randomised Phase IV Study to Investigate Acalabrutinib Monotherapy Compared to Investigator's Choice of Treatment in Adults (> 18 Years) With Chronic Lymphocytic Leukaemia and Moderate to Severe Cardiac Impairment","Inclusion Criteria:\n\n1. Men and women ≥ 18 years of age, at the time of signing the informed consent.\n2. Eastern Cooperative Oncology Group performance status of 0 to 3\n3. Left ventricular ejection fraction assessed by ECHO \\\u003C 50%.\n4. Diagnosis of CLL\n5. Treatment naïve or relapsed\u002Frefractory patients who received no more than 2 prior lines of systemic anti-CLL treatment.\n6. Active disease per iwCLL 2018 criteria that requires treatment.\n7. Meet the following laboratory parameters:\n\n   1. Absolute neutrophil count (ANC) ≥ 500 cells\u002FμL (0.50 × 109\u002FL).\n   2. Platelet count ≥ 30,000 cells\u002FμL (30 × 109\u002FL).\n   3. Serum aspartate aminotransferase and ALT ≤ 3.0 × ULN.\n   4. Total bilirubin ≤ 1.5 × ULN unless directly attributable to Gilbert's syndrome.\n   5. Estimated creatinine clearance (ie, estimated glomerular filtration rate \\[eGFR\\] using Cockcroft-Gault) ≥ 40 mL\u002Fmin, or serum creatinine ≤ 2 × ULN.\n8. Women and men who are sexually active and can bear children must agree to use highly effective forms of contraception while on the study and for 2 days after the last dose of acalabrutinib.\n9. Patients must be willing and able to adhere to the study visit schedule, understand, and comply with other protocol requirements, and provide written informed consent and authorisation to use protected health information (in accordance with national and local patient privacy regulations). Note: vulnerable patients, as defined in the ICH GCP, are not allowed on this protocol (eg, prisoners or institutionalised patients).\n\nExclusion Criteria:\n\n1. Known active CNS leukaemia, leptomeningeal disease or spinal cord compression. In case of R\u002FR patients with prior history of CNS localisation of leukaemia who received treatment are eligible provided that there is no evidence of CNS involvement at study entry as documented by cerebrospinal fluid (CSF) cytology and\u002For brain MRI.\n2. Ongoing Richter's transformation.\n3. Prior exposure to a BTKi.\n4. Major surgery within 30 days before first dose of study treatment.\n5. Uncontrolled haemolytic anaemia.\n6. Received any investigational drug within 30 days or 5 half-lives (whichever is shorter) before first dose of study treatment.\n7. Received a live virus vaccination within 28 days of first dose of study treatment.\n8. History of or ongoing confirmed PML.\n9. History of prior malignancy except for the following:\n\n   1. Prior history of malignancy with no evidence of active disease present for more than\n\n3 years before screening or felt to be at low risk for recurrence by treating physician.\n\n(b) Adequately treated lentigo maligna melanoma without current evidence of disease or adequately resected non-melanomatous skin cancer (ie, basal cell carcinoma or squamous cell carcinoma of the skin). (c) Curatively treated in situ carcinoma of the cervix or carcinoma in situ of the prostate at any time prior to study without current evidence of disease. 10 Unable to swallow tablets or malabsorption syndrome, or disease significantly affecting gastrointestinal function, or resection of the stomach or small bowel or gastric bypass, symptomatic inflammatory bowel disease, or partial or complete bowel obstruction.\n\n11 Active uncontrolled systemic infection (bacterial, fungal, viral or other) or clinically significant localised infection. 12 Known history of infection with human immunodeficiency virus (HIV). 13 Serologic status reflecting active HepB or HepC infection.\n\n1. Patients with HepB core antibody positive who are surface antigen negative or who are HepC antibody positive will need to have a negative polymerase chain reaction (PCR) result before randomisation and must be willing to undergo deoxyribonucleic acid (DNA) PCR testing during the study.\n2. Patients who are HepB surface antigen positive or HepB PCR positive and those who are HepC PCR positive will be excluded. 14 History of stroke or intracranial haemorrhage within 6 months prior to randomisation.\n\n   15 History of bleeding diathesis (eg, haemophilia, von Willebrand disease). 16 Requires or receiving anticoagulation with warfarin or equivalent vitamin K antagonists (eg, phenprocoumon) within 7 days of first dose of study treatment. Direct anti-X (DOACs) or low molecular weight heparins (LMWH, eg, enoxaparin) on stable dosing schedule is allowed. 17 Requires treatment with a strong cytochrome P450 3A (CYP3A) inhibitor\u002Finducer. The use of strong CYP3A inhibitors within 1 week or strong CYP3A inducers within 3 weeks of the first dose of study treatment is prohibited. 18 Breastfeeding or pregnant. 19 Concurrent participation in another therapeutic clinical trial. 20 Uncontrolled cardiac\u002Fcardiovascular disease including the following:\n   * Uncontrolled cardiac tachyarrhythmias (sinus, atrial or ventricular) that require new\u002Fadditional therapy within the last month.\n   * Clinically significant outlying QT interval corrected by Fridericia's formula (QTcF) values; QTcF \\> 470 ms or QTcF \\\u003C 330 ms.\n   * Unstable ischaemic heart disease (IHD), recent (\\\u003C 3 months): episode of acute coronary syndrome, including acute myocardial infarction and unstable angina pectoris.\n   * Percutaneous coronary intervention, or coronary artery bypass graft within the last month. 21 Uncontrolled hypertension despite optimal management. 22 Current life-threatening illness, medical conditions, organ system dysfunction or lifestyle habits which, in the investigator's opinion, could compromise the patient's safety or ability to adhere to the study protocol.","ALL","18 Years","130 Years",{"count":20,"type":21},60,"ESTIMATED","INTERVENTIONAL",[24],"PHASE4","This will be a global Phase IV, open-label, randomised study to evaluate the safety and tolerability of acalabrutinib (monotherapy, 100 mg orally \\[po\\], twice daily \\[bd\\]) compared to investigator's choice of treatment, in patients with CLL (TN or R\u002FR) and moderate to severe cardiac impairment. All patients will have cardiac impairment as defined by LVEF of \\\u003C 50%.\n\nRandomisation will be stratified by LVEF \\> 40% vs ≤ 40% to stratify for moderate and severe cardiac impairment, which for this study are defined as follows:\n\nSevere cardiac impairment: in those with LVEF ≤ 40% Moderate cardiac impairment: in those with LVEF \\> 40% to \\\u003C 50%. The study is planned to take place in approximately 20 centres globally. The study will be conducted in centres that have established close collaboration between the Haematology and Cardiology divisions, preferably with a cardio-oncologist on the team.\n\nAn IDMC will be responsible for making recommendations for study continuation.",[27,28],"Chronic Lymphocytic Leukaemia","Heart Failure",[30,31],"Hemic Diseases","Lymphatic Diseases","RECRUITING","2026-06-17",{"date":35,"type":36},"2026-06-18","ACTUAL",{"date":38,"type":36},"2025-02-04",{"date":40,"type":21},"2030-08-16",{"name":42,"class":43},"AstraZeneca","INDUSTRY",23,{"id":46,"slug":47,"hasResults":11,"nctId":48,"briefTitle":49,"officialTitle":50,"acronym":4,"eligibilityCriteria":51,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":52,"targetDuration":4,"studyType":22,"phases":54,"briefSummary":56,"conditions":57,"keywords":4,"overallStatus":32,"whyStopped":4,"lastUpdateSubmitDate":61,"lastUpdatePostDateStruct":62,"startDateStruct":64,"completionDateStruct":66,"leadSponsor":68,"locationsCount":70},"100418452","phase-2-efficacy-and-safety-of-nemtabrutinib-mk-1026-in-participants-with-hematologic-malignancies-mk-1026-003-100418452","NCT04728893","Efficacy and Safety of Nemtabrutinib (MK-1026) in Participants With Hematologic Malignancies (MK-1026-003)","A Phase 2 Study to Evaluate the Efficacy and Safety of MK-1026 in Participants With Hematologic Malignancies","Inclusion Criteria:\n\n* Has an Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 2 within 7 days before C1D1 (the first dose of study treatment)\n* Has a life expectancy of at least 3 months, based on the investigator assessment\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 viral load prior to randomization\n* Participants with history of Hepatitis C virus (HCV) infection are eligible if HCV viral load is undetectable at screening\n* Has adequate organ function\n* Male participants agree to refrain from donating sperm and agree to either remain abstinent from penile-vaginal intercourse as their preferred and usual lifestyle OR agree to use contraception, during the intervention period and for at least the time required to eliminate the study intervention after last dose of study intervention\n* Female participants assigned female sex at birth who are not pregnant or breastfeeding are eligible to participate if not a participant of childbearing potential (POCBP), or if a POCBP they either use a contraceptive method that is highly effective OR remain abstinent from penile-vaginal intercourse as their preferred and usual lifestyle during the intervention period and for at least to eliminate study intervention after the last dose of study intervention\n* Participants with Human immunodeficiency virus (HIV) are eligible if they meet all of the following: the CD4 count is \\>350 cells\u002FuL at screening, the HIV viral load is below the detectable level, are on a stable ART regimen for at least 4 weeks prior to study entry, and are compliant with their ART\n\nPart 1 and Part 2 (Cohorts A to C and J)\n\n* Has a confirmed diagnosis of Chronic lymphocytic leukemia\u002F Small lymphocytic lymphoma (CLL\u002FSLL) with\n\n  * At least 2 lines of prior therapy (Part 1 only)\n  * Part 2 Cohort A: CLL\u002FSLL participants who are relapsed or refractory to prior therapy with a covalent, irreversible Bruton's tyrosine kinase inhibitor (BTKi), and a B-cell lymphoma 2 inhibitor (BCL2i). CLL participants must have received and failed, been intolerant to, or determined by their treating physician to be a poor phosphoinositide 3-kinase inhibitor (PI3Ki) candidate or ineligible for a PI3Ki per local guidelines\n  * Part 2 Cohort B: CLL\u002FSLL participants who are relapsed or refractory following at least 1 line of prior therapy and are BTKi treatment naive\n  * Part 2 Cohort C: CLL\u002FSLL participants with 17p deletion or tumor protein p53 (TP53) mutation who are relapsed or refractory following at least 1 line of prior therapy\n  * Part 2 Cohort J: CLL\u002FSLL participants whose disease relapsed or was refractory to prior therapy with a covalent\u002Firreversible BTKi and BCL2i. NOTE: As of Protocol Amendment 09, at least 10 CLL\u002FSLL participants whose disease relapsed or was refractory to prior therapy with a covalent\u002Firreversible BTKi, BCL2i and noncovalent\u002Freversible BTKi (all three classes of therapies are required) will be enrolled into Cohort J\n  * Has active disease for CLL\u002FSLL clearly documented to initiate therapy\n  * For SLL participants in Part 2: Has evaluable core or excisional lymph node biopsy for biomarker analysis from an archival or newly obtained biopsy or bone marrow aspirate at Screening (optional for participants enrolling in Part 1)\n\nPart 2 (Cohorts D to G)\n\n\\- Has a confirmed diagnosis of and meets the following prior therapy requirements:\n\n* Participants with Richter's transformation who are relapsed or refractory following at least 1 line of prior therapy (Cohort D)\n* Participants with pathologically confirmed Mantle-cell lymphoma (MCL), documented by either overexpression of cyclin D1 or t (11;14), who are relapsed or are refractory to chemoimmunotherapy and a covalent irreversible BTKi (Cohort E)\n* Participants with Marginal zone lymphoma (MZL) (including splenic, nodal, and extra nodal MZL) who are relapsed or refractory to at least one prior line of systemic therapy including an anti-CD20-based regimen\n* Participants with Follicular lymphoma (FL) who are relapsed or refractory to chemoimmunotherapy and immunomodulatory agents (such as lenalidomide based regimen) (Cohort G)\n* Have measurable disease defined as at least 1 lesion that can be accurately measured in at least 2 dimensions with spiral Computed tomography (CT) scan\n* Has a lymph node biopsy for biomarker analysis from an archival or newly obtained biopsy or bone marrow aspirate (Cohort D) at Screening\n\nPart 2 (Cohort H): confirmed diagnosis of Waldenström's macroglobulinemia (WM); participants who are relapsed or refractory to standard therapies for WM including chemoimmunotherapy and a covalent irreversible BTKi\n\n* Has active disease defined as 1 of the following: systemic symptoms, physical findings, laboratory abnormalities, coexisting disease\n* Has measurable disease, satisfying any of the following: at least 1 lesion that can be accurately measured in at least 2 dimensions with spiral CT scan (minimum measurement must be \\>15 mm in the longest diameter or \\>10 mm in the short axis); IgM ≥450 mg\u002FdL; or bone marrow infiltration of 10%\n* Has fresh bone marrow aspirate or a lymph node biopsy for biomarker analysis at Screening or a lymph node biopsy from an archival\n\nExclusion Criteria:\n\n* Has active HBV\u002FHCV infection (Part 1 and Part 2)\n* Has a history of malignancy ≤3 years before providing documented informed consent. Participants with basal cell carcinoma of skin, squamous cell carcinoma of skin, or carcinoma in situ (e.g., breast carcinoma, cervical cancer in situ) that have undergone potential curative therapy are not excluded. Participants with low-risk, early-stage prostate cancer (T1-T2a, Gleason score ≤6, and prostate-specific antigen \\\u003C10 ng\u002FmL) either treated with definitive intent or untreated in active surveillance with SD are not excluded\n* Has active central nervous system (CNS) disease\n* Has an active infection requiring systemic therapy\n* Has received prior systemic anti-cancer therapy within 5 half-lives or 4 weeks (if prior therapy was a monoclonal antibody) before C1D1\n* Is currently participating in or has participated in a study of an investigational agent or has used an investigational device within 4 weeks prior to the first dose of study intervention\n* Has any clinically significant gastrointestinal abnormalities that might alter absorption\n* History of severe bleeding disorders",{"count":53,"type":21},490,[55],"PHASE2","The purpose of this study is to evaluate the safety and efficacy of nemtabrutinib (formerly ARQ 531) in participants with hematologic malignancies of chronic lymphocytic leukemia (CLL)\u002F small lymphocytic lymphoma (SLL), Richter's transformation, marginal zone lymphoma (MZL), mantle cell lymphoma (MCL), follicular lymphoma (FL), and Waldenström's macroglobulinemia (WM).",[58,59,60,27],"Hematologic Malignancies","Waldenstroms Macroglobulinaemia","Non-Hodgkins Lymphoma","2026-06-10",{"date":63,"type":36},"2026-06-12",{"date":65,"type":36},"2021-04-05",{"date":67,"type":21},"2029-01-04",{"name":69,"class":43},"Merck Sharp & Dohme LLC",121,{"id":72,"slug":73,"hasResults":11,"nctId":74,"briefTitle":75,"officialTitle":76,"acronym":77,"eligibilityCriteria":78,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":79,"targetDuration":4,"studyType":22,"phases":81,"briefSummary":83,"conditions":84,"keywords":89,"overallStatus":32,"whyStopped":4,"lastUpdateSubmitDate":100,"lastUpdatePostDateStruct":101,"startDateStruct":102,"completionDateStruct":104,"leadSponsor":106,"locationsCount":107},"100559431","phase-1-a-study-of-azd0486-monotherapy-or-in-combination-with-other-anti-cancer-agents-for-mature-b-cell-malignancies-100559431","NCT06564038","A Study of AZD0486 Monotherapy or in Combination With Other Anti-Cancer Agents for Mature B-Cell Malignancies","A Phase I\u002FII Open-Label Multi-Centre Master Protocol to Evaluate the Safety and Efficacy of AZD0486 Monotherapy or in Combination With Other Anticancer Agents in Participants With Mature B-Cell Malignancies","Soundtrack-E","Inclusion Criteria:\n\nMaster Inclusion Criteria applicable to all substudies:\n\n* Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 2.\n* Contraception use during treatment and at least 90 days after final dose.\n* Confirmed CD19 expression if prior anti-CD19 therapy.\n\nSubstudy 1 Specific Inclusion Criteria:\n\n* Participants with CLL must require treatment according to the international workshop on Chronic Lymphocytic Leukemia (iwCLL) criteria.\n* SLL: at least 1 measurable site per Lugano.\n* Absolute lymphocyte count (ALC) \\\u003C25000 cells\u002FmcL.\n* Cohort 1A and 1C: at least 2 prior lines of systemic therapy for CLL\u002FSLL.\n* Cohort 1B: at least 1 prior line of therapy and is bruton tyrosine kinase inhibitor (BTKi)-sensitive.\n\nSubstudy 2 Specific Inclusion Criteria:\n\n* MCL diagnosis per WHO.\n* Clinical Stage II, III, or IV by Ann Arbor Classification.\n* At least 1 measurable site per Lugano.\n* ALC \\\u003C 25000 cells\u002FmcL.\n* Cohort 2A and 2C: Relapse or progressed after 2 or more lines of therapy including BTKi.\n\nSubstudy 3 Specific Inclusion Criteria:\n\n* At least 1 measurable site as per Lugano.\n* Left ventricular ejection fraction (LVEF) ≥50%.\n* Participant must be no older than 79 years of age at the time of signing ICF.\n* Contraception at least 90 days after last dose of surovatamig or 4 months after last dose of vincristine, and 6 months after the last dose of cyclophosphamide, or doxorubicin.\n* Cohort 3A:\n\n  1. Histologically confirmed diagnosis of previously untreated large B-cell Lymphoma (LBCL) per WHO 2022.\n  2. R\u002FR B-NHL after at least 1 prior lines of systemic therapy.\n  3. International Prognostic Index (IPI) 2-5.\n* Cohort 3B:\n\n  1. Histologically confirmed diagnosis of previously untreated large B-cell Lymphoma (LBCL) per WHO 2022.\n  2. IPI score of 2 to 5.\n\nExclusion Criteria:\n\nMaster Exclusion Criteria applicable to all substudies:\n\n* Central nervous system (CNS) lymphoma.\n* Surgery within 14 days of study drug.\n* Clinically significant cardiovascular (CV) disease.\n* Unresolved Grade \\>2 AEs from prior anticancer therapy (except alopecia or fatigue).\n* Any systemic therapy within 5 half-lives or 21 days (whichever is shorter) prior to treatment.\n* Radiation therapy within 28 days.\n* Prior CAR T-cell therapy or autologous-haematopoietic stem cell transplant (HSCT) within 12 weeks or prior T-cell engager (TCE) within 8 weeks.\n* Prior Grade \\> 3 cytokine release syndrome (CRS) or immune effector cell-associated neurotoxicity syndrome (ICANS) event.\n* Prior allogeneic HSCT or solid organ transplantation within 24 weeks of starting Cycle 1 Day 1.\n* Active, significant, uncontrolled infection or autoimmune disease requiring systemic therapy including participants with known history of haemophagocytic lymphohistiocytosis (HLH).\n\nSubstudy 1 Specific Exclusion Criteria:\n\n* CLL\u002FSLL transformation to more aggressive form of lymphoma.\n* Cohort 1B: bleeding diathesis, CYP3A inhibitor or inducer, history of ICH or stroke within 24 weeks, GI malabsorption, receiving vitamin K antagonist.\n\nSubstudy 3 Specific Exclusion Criteria:\n\n* Mediastinal grey-zone lymphoma, Burkitt, Richter's transformation, primary effusion large B-cell lymphoma (LBCL).\n* Cumulative dose of anthracycline \\>150 mg\u002Fm2.",{"count":80,"type":21},408,[82,55],"PHASE1","The purpose of this study is to assess the safety and efficacy of surovatamig (formerly AZD0486) administered as monotherapy or in combination with other anticancer agents in participants with hematological malignancies",[27,85,86,87,88],"Small Lymphocytic Lymphoma","Mantle-cell Lymphoma","Large B-cell Lymphoma","B-cell Non-Hodgkin Lymphoma",[90,91,92,93,94,95,96,97,98,99],"IgG4 fully human CD19xCD3 bispecific T-cell engager","B cell lymphoma","Subcutaneous","Acalabrutinib","Prednisone","Rituximab","Cyclophosphamide","Vincristine","Doxorubicin","Surovatamig","2026-06-09",{"date":61,"type":36},{"date":103,"type":36},"2025-01-30",{"date":105,"type":21},"2029-06-11",{"name":42,"class":43},64,{"id":109,"slug":110,"hasResults":11,"nctId":111,"briefTitle":112,"officialTitle":113,"acronym":4,"eligibilityCriteria":114,"healthyVolunteers":11,"sex":16,"minAge":4,"maxAge":4,"enrollmentInfo":115,"targetDuration":4,"studyType":117,"phases":4,"briefSummary":118,"conditions":119,"keywords":4,"overallStatus":32,"whyStopped":4,"lastUpdateSubmitDate":122,"lastUpdatePostDateStruct":123,"startDateStruct":125,"completionDateStruct":127,"leadSponsor":129,"locationsCount":131},"100543583","transgene-assay-testing-service-of-tumor-samples-from-patients-who-received-a-bristol-myers-squibb-manufactured-gene-modified-cell-therapy-and-have-a-qualifying-second-primary-malignancy-100543583","NCT06357754","Transgene Assay Testing Service of Tumor Samples From Patients Who Received a Bristol-Myers Squibb Manufactured Gene Modified Cell Therapy and Have a Qualifying Second Primary Malignancy","Protocol for Transgene Assay Service","Inclusion Criteria:\n\n* Participant has received a commercially available Bristol-Myers Squibb (BMS) manufactured Gene Modified Cell Therapy (GMCT) and has been diagnosed with a qualifying second primary malignancy or a second primary malignancy which BMS has qualified for testing.\n* Participant has received a commercially available BMS manufactured GMCT in a clinical trial or other investigational setting (including non-conforming product) for which there is no testing protocol in place for that trial or investigational setting and has been diagnosed with a qualifying second primary malignancy or a second primary malignancy which BMS has qualified for testing.\n\nExclusion Criteria:\n\n* Participant is actively participating in a clinical trial where information and sample collection is being conducted under that clinical trial.\n* Participant has not received a BMS manufactured GMCT or has not been diagnosed with a qualifying second primary malignancy.",{"count":116,"type":21},50,"OBSERVATIONAL","The purpose of this transgene assay testing service is to evaluate tumor samples for transgene levels in patients who received a commercially available Bristol-Myers Squibb manufactured gene modified cellular therapy and have reported a qualifying second malignancy.",[120,27,121],"Non-Hodgkin Lymphoma","Multiple Myeloma","2026-01-21",{"date":124,"type":36},"2026-01-22",{"date":126,"type":36},"2023-10-06",{"date":128,"type":21},"2038-10-06",{"name":130,"class":43},"Bristol-Myers Squibb",8]