Clinical Trials Using Venetoclax

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Clinical trials are research studies that involve people. The clinical trials on this list are studying Venetoclax. All trials on the list are supported by NCI.

NCI’s basic information about clinical trials explains the types and phases of trials and how they are carried out. Clinical trials look at new ways to prevent, detect, or treat disease. You may want to think about taking part in a clinical trial. Talk to your doctor for help in deciding if one is right for you.

Trials 1-25 of 32
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  • A Study of Venetoclax in Combination With Azacitidine Versus Azacitidine in Treatment Naïve Subjects With Acute Myeloid Leukemia Who Are Ineligible for Standard Induction Therapy

    Acute Myeloid Leukaemia (AML) is an aggressive and rare cancer of myeloid cells (a white blood cell responsible for fighting infections). Successful treatment of AML is dependent on what subtype of AML the patient has, and the age of the patient when diagnosed. Venetoclax is an experimental drug that kills cancer cells by blocking a protein (part of a cell) that allows cancer cells to stay alive. This study is designed to see if adding venetoclax to azacitidine works better than azacitidine on its own. This is a Phase 3, randomized, double-blind (treatment is unknown to patients and doctors), placebo controlled study in patients with AML who are >= 18 or more years old and have not been treated before. Patients who take part in this study should not be suitable for standard induction therapy (usual starting treatment). AbbVie is funding this study which will take place at approximately 180 hospitals globally and enroll approximately 400 patients. In this study, 2 / 3 of patients will receive venetoclax every day with azacitidine and the remaining 1 / 3 will receive placebo (dummy) tablets with azacitidine. Patients will continue to have study visits and receive treatment for as long as they are having a clinical benefit. The effect of the treatment on AML will be checked by taking blood, bone marrow, scans, measuring side effects and by completing health questionnaires. Blood and bone marrow tests will be completed to see why some people respond better than others. Additional blood tests will be completed for genetic factors and to see how long the drug remains in the body.
    Location: 14 locations

  • A Study Evaluating Venetoclax in Combination With Azacitidine in Subjects With Treatment-Naïve Higher-Risk Myelodysplastic Syndromes (MDS)

    This is a Phase 1b, open-label, non-randomized, multicenter, dose-finding study evaluating venetoclax in combination with azacitidine in subjects with treatment-naïve higher-risk MDS comprising a dose-escalation portion and a safety expansion portion.
    Location: 9 locations

  • A Study of Venetoclax in Combination With Cobimetinib and Venetoclax in Combination With Idasanutlin in Patients Aged > / = 60 Years With Relapsed or Refractory Acute Myeloid Leukemia Who Are Not Eligible for Cytotoxic Therapy

    The primary objective for this study is to assess the safety and tolerability as well as preliminary efficacy of venetoclax in combination with cobimetinib, and venetoclax in combination with idasanutlin in patients > / = 60 years of age with relapsed or refractory acute myeloid leukemia (R / R) AML who are not eligible for cytotoxic therapy.
    Location: 8 locations

  • Bendamustine Hydrochloride, Rituximab, Ibrutinib, and Venetoclax in Treating Patients with Relapsed or Refractory Mantle Cell Lymphoma

    This phase I trial studies the side effects and best dose of venetoclax when giving together with bendamustine hydrochloride, rituximab, and ibrutinib in treating patients with mantle cell lymphoma that has come back or does not respond to treatment. Drugs used in chemotherapy, such as bendamustine hydrochloride and venetoclax, work in different ways to stop the growth of cancer cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Monoclonal antibodies, such as rituximab, may interfere with the ability of cancer cells to grow and spread. Ibrutinib may stop the growth of cancer cells by blocking some of the enzymes needed for cell growth. Giving bendamustine hydrochloride, rituximab, ibrutinib, and venetoclax may work better in treating patients with mantle cell lymphoma.
    Location: 6 locations

  • A Study of Venetoclax in Combination With Navitoclax and Chemotherapy in Subjects With Relapsed / Refractory Acute Lymphoblastic Leukemia or Relapsed / Refractory Lymphoblastic Lymphoma

    This dose-escalating study is to determine the safety, pharmacokinetics, and preliminary efficacy of venetoclax in combination with navitoclax and chemotherapy in adult and pediatric participants with relapsed / refractory acute lymphoblastic leukemia (ALL) or relapsed / refractory lymphoblastic lymphoma (LL).
    Location: 6 locations

  • A Study Evaluating the Safety and Pharmacokinetics of ABBV-075 in Subjects With Cancer

    This is a Phase 1, first-in-human, dose escalation study in participants with advanced solid tumors to determine the pharmacokinetics, maximum tolerated dose and the recommended Phase 2 dose of ABBV-075 at different monotherapy dosing schedules. In addition the study will evaluate the safety. tolerability and the pharmacokinetics of ABBV-075 monotherapy or combination therapy in disease specific expansion cohorts.
    Location: 8 locations

  • A Study Evaluating Venetoclax Alone and in Combination With Azacitidine in Subjects With Higher-Risk Myelodysplastic Syndromes (MDS) After Hypomethylating Agent-Failure

    This is a Phase 1b, dose-ranging, open-label, multicenter study designed to evaluate the safety and pharmacokinetics of venetoclax as a single-agent and in combination with azacitidine in participants with higher-risk Myelodysplastic Syndromes (MDS) after Hypomethylating Agent (HMA)-Failure.
    Location: 8 locations

  • Venetoclax in Treating Patients with Relapsed or Refractory Waldenstrom Macroglobulinemia

    This phase II trial studies how well venetoclax works in treating patients with Waldenstrom macroglobulinemia that has come back or does not respond to treatment. Venetoclax may stop the growth of cancer cells by blocking some of the enzymes needed for cell growth.
    Location: 5 locations

  • A Study of Obinutuzumab, Rituximab, Polatuzumab Vedotin, and Venetoclax in Relapsed or Refractory Follicular Lymphoma (FL) or Diffuse Large B-Cell Lymphoma (DLBCL)

    This study will evaluate the safety, efficacy, and pharmacokinetics of induction treatment with obinutuzumab, polatuzumab vedotin, and venetoclax in participants with relapsed or refractory FL, and with rituximab, polatuzumab vedotin, and venetoclax in participants with DLBCL. Participants with FL who achieve complete response (CR), partial response (PR), or stable disease (SD) at the end of induction therapy will receive post-induction treatment with obinutuzumab and venetoclax, and participants with DLBCL who achieve CR or PR at the end of induction (EOI) will receive post-induction treatment with rituximab and venetoclax.
    Location: 6 locations

  • A Study of the Safety and Pharmacokinetics of Venetoclax in Pediatric and Young Adult Patients With Relapsed or Refractory Malignancies

    An open-label, global, multi-center study to evaluate the safety and pharmacokinetics of venetoclax monotherapy, to determine the dose limiting toxicity (DLT) and the recommended Phase 2 dose (RPTD), and to assess the preliminary efficacy of venetoclax in pediatric and young adult participants with relapsed or refractory malignancies.
    Location: 5 locations

  • Venetoclax, Rituximab, and Combination Chemotherapy in Treating Patients with Richter Syndrome

    This phase II trial studies how well venetoclax, rituximab, and combination chemotherapy works in treating patients with Richter syndrome. Venetoclax may stop the growth of cancer cells by blocking some of the enzymes needed for cell growth. Monoclonal antibodies, such as rituximab, may interfere with the ability of cancer cells to grow and spread. Drugs used in chemotherapy, such as etoposide, prednisone, vincristine sulfate, cyclophosphamide, and doxorubicin hydrochloride, work in different ways to stop the growth of cancer cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Giving venetoclax, rituximab, and combination chemotherapy may work better in treating patients with Richter syndrome.
    Location: 4 locations

  • Venetoclax and Combination Chemotherapy in Treating Patients with B or T Cell Acute Lymphoblastic Leukemia

    This phase Ib trial studies the side effects and best dose of venetoclax when given together with combination chemotherapy in treating patients with B or T cell acute lymphoblastic leukemia. Venetoclax may stop the growth of cancer cells by blocking some of the enzymes needed for cell growth. Drugs used in chemotherapy, such as cyclophosphamide, vincristine sulfate, dexamethasone, methotrexate, methylprednisolone, cytarabine, mercaptopurine, and prednisone, work in different ways to stop the growth of cancer cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Giving more than one drug (combination chemotherapy) and venetoclax may kill more cancer cells.
    Location: 3 locations

  • Study to Evaluate Safety and Preliminary Efficacy of MOR208 With Idelalisib or Venetoclax in R / R CLL / SLL Patients Pretreated With BTKi (COSMOS)

    This is a two-cohort, multicenter, open-label study of MOR00208 combined with idelalisib or venetoclax in adult patients with R / R CLL or R / R SLL pretreated with a BTK inhibitor (e.g., ibrutinib) as single agent or as part of combination therapy.
    Location: 3 locations

  • Venetoclax and Cytarabine with or without Idarubicin Hydrochloride in Treating Pediatric Patients with Refractory or Relapsed Acute Myeloid Leukemia

    This phase I trial studies the side effects and best dose of venetoclax and cytarabine when given with or without idarubicin hydrochloride in treating pediatric patients with acute myeloid leukemia that does not respond to treatment or has returned after a period of improvement. Venetoclax may stop the growth of cancer cells by blocking some of the enzymes needed for cell growth. Drugs used in chemotherapy, such as cytarabine and idarubicin hydrochloride, work in different ways to stop the growth of cancer cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Giving venetoclax, cytarabine, and idarubicin hydrochloride may work better in treating pediatric patients with acute myeloid leukemia.
    Location: 2 locations

  • A Study of Obinutuzumab in Combination With Idasanutlin and Venetoclax in Participants With Relapsed or Refractory (R / R) Follicular Lymphoma (FL) or Rituximab in Combination With Idasanutlin and Venetoclax in Participants With R / R Diffuse Large B-Cell Lymphoma (DLBCL)

    This Phase Ib / II, open-label, multicenter, non-randomized, dose-escalation study will evaluate the safety, efficacy, and pharmacokinetics of obinutuzumab in combination with idasanutlin and venetoclax in participants with R / R FL and obinutuzumab or rituximab in combination with idasanutlin and venetoclax in participants with R / R DLBCL. The study will include an initial dose-escalation phase followed by an expansion phase. The dose-escalation phase is designed to determine the recommended phase II doses (RP2Ds) and regimen for idasanutlin and venetoclax in combination with obinutuzumab for FL participants and in combination with rituximab for DLBCL participants.
    Location: 3 locations

  • Phase II Venetoclax, Obinutuzumab and Bendamustine in High Tumor Burden Follicular Lymphoma as Front Line Therapy

    Patients with high tumor burden, low grade follicular lymphoma that has never been treated, will receive venetoclax in combination with obinutuzumab and bendamustine. Venetoclax is an oral Bcl-2 family protein inhibitor. It targets the B-cell lymphoma 2 (BCL-2) protein, which supports cancer cell growth and is overexpressed in many patients with follicular lymphoma. Venetoclax may help to slow down the growth of cancer or may cause cancer cells to die. The purpose of this study is to see whether adding venetoclax to obinutuzumab and bendamustine improves the response (the tumor shrinks or disappears) in patients with follicular lymphoma.
    Location: 5 locations

  • A Study of Combination Therapy With Venetoclax, Daratumumab and Dexamethasone (With and Without Bortezomib) in Subjects With Relapsed or Refractory Multiple Myeloma

    This is a study of venetoclax, daratumumab, and dexamethasone with and without bortezomib combination therapy to evaluate safety, tolerability, and efficacy of these combinations in participants with relapsed or refractory multiple myeloma. The study will consist of 2 distinct parts: Part 1 includes participants with t(11;14) positive relapsed / refractory (R / R) multiple myeloma who will receive venetoclax in combination with daratumumab and dexamethasone (VenDd); Part 2 includes participants with R / R multiple myeloma who will receive venetoclax in combination with daratumumab, bortezomib, and dexamethasone (VenDVd). Each Part will be initiated with a dose-escalation phase. During the open-label, escalation phases, increasing doses of venetoclax with fixed doses of daratumumab and dexamethasone (Part 1a) or daratumumab, bortezomib, and dexamethasone (Part 2a) will be administered. The dose-escalation phases will be followed by either a randomized, and blinded (Part 1b) expansion phase or single-arm and open-label (Part 2b) expansion phase.
    Location: 2 locations

  • A Study to Evaluate the Safety, Pharmacokinetics, and Clinical Activity of the Combination of RO6870810 and Venetoclax, With or Without Rituximab, in Participants With Relapsed / Refractory Diffuse Large B-Cell Lymphoma (DLBCL)

    The purpose of this study is to evaluate the safety, tolerability and clinical activity of RO6870810 in combination with venetoclax and when co-administered with rituximab in participants with relapse / refractory (R / R) diffuse large B-cell lymphoma (DLBCL).
    Location: City of Hope Comprehensive Cancer Center, Duarte, California

  • Venetoclax, Ibrutinib, Prednisone, Obinutuzumab, and Lenalidomide in Treating Patients with Relapsed or Refractory B-Cell Lymphoma

    This phase Ib trial studies the best dose and side effects of venetoclax in combination with ibrutinib, prednisone, obinutuzumab and lenalidomide in treating patients with B-cell lymphoma that has come back or not responding to treatment. Drugs used in chemotherapy, such as venetoclax, prednisone and lenalidomide, work in different ways to stop the growth of cancer cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Ibrutinib may stop the growth of cancer cells by blocking some of the enzymes needed for cell growth. Monoclonal antibodies, such as obinutuzumab, may interfere with the ability of cancer cells to grow and spread. Giving venetoclax in combination with ibrutinib, prednisone, obinutuzumab and lenalidomide, may work better at treating B-cell lymphoma.
    Location: National Institutes of Health Clinical Center, Bethesda, Maryland

  • A Study of the Safety and Tolerability of ABBV-621 in Participants With Previously Treated Solid Tumors and Hematologic Malignancies

    This is an open-label, Phase I, dose-escalation study to determine the maximum tolerated dose (MTD) and / or recommended phase two dose (RPTD), and evaluate the safety, efficacy, and pharmacokinetic (PK) profile of ABBV-621 for participants with previously treated solid tumors or hematologic malignancies. The study will consist of 2 segments: Segment I (Dose Escalation for Solid Tumors) and Segment II (Dose Expansion for Solid Tumors; RPTD confirmation for Acute Myeloid Leukemia [AML]; combination with venetoclax for AML and Diffuse Large B-Cell Lymphoma [DLBCL]).
    Location: University of Chicago Comprehensive Cancer Center, Chicago, Illinois

  • A Study of Venetoclax in Combination With Low Dose Cytarabine Versus Low Dose Cytarabine Alone in Treatment Naïve Patients With Acute Myeloid Leukemia Who Are Ineligible for Intensive Chemotherapy

    Acute Myeloid Leukaemia (AML) is an aggressive and rare cancer of myeloid cells (a white blood cell responsible for fighting infections). Successful treatment of AML is dependent on what subtype of AML the patient has, and the age of the patient when diagnosed. Venetoclax is an experimental drug that kills cancer cells by blocking a protein (part of a cell) that allows cancer cells to stay alive. This study is designed to see if adding venetoclax to cytarabine works better than cytarabine on its own. This is a Phase 3, randomized, double-blind (treatment unknown to patients and doctors), placebo-controlled, multicenter study in patients with AML who are 18 or more years old and have not been treated before. Patients who take part in this study should not be suitable for intensive induction chemotherapy (usual starting treatment). Abbvie is funding this study which will take place at approximately 125 hospitals globally and enrol approximately 175 patients. In this study, 2 / 3 of patients will receive venetoclax every day with cytarabine and the remaining 1 / 3 will receive placebo (dummy) tablets with azacitidine. Patients will continue to have study visits and receive treatment for as long as they are having a clinical benefit. The effect of the treatment on AML will be checked by taking blood, bone marrow, scans, measuring side effects and by completing health questionnaires. Blood and bone marrow tests will be completed to see why some people respond better than others. Additional blood tests will be completed for genetic factors and to see how long the drug remains in the body.
    Location: 2 locations

  • Venetoclax and Combination Chemotherapy in Treating Patients with Relapsed or Refractory Diffuse Large B-Cell Lymphoma

    This phase I trial studies the side effects and best dose of venetoclax when given together with combination chemotherapy in treating patients with diffuse large B-cell lymphoma that has come back or does not respond to treatment. Venetoclax may stop the growth of cancer cells by blocking some of the enzymes needed for cell growth. Drugs used in chemotherapy, such as rituximab, ifosfamide, carboplatin, and etoposide, work in different ways to stop the growth of cancer cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Giving venetoclax and combination chemotherapy may work better in treating patients with diffuse large B-cell lymphoma.
    Location: Case Comprehensive Cancer Center, Cleveland, Ohio

  • Venetoclax and Ibrutinib in Treating Patients with Relapsed or Refractory Chronic Lymphocytic Leukemia or Small Lymphocytic Lymphoma

    This phase II trial studies the side effects and best dose of venetoclax when given together with ibrutinib and to see how well they work in treating patients with chronic lymphocytic leukemia or small lymphocytic lymphoma that has come back or does not respond to treatment. Venetoclax and ibrutinib may stop the growth of cancer cells by blocking some of the enzymes needed for cell growth.
    Location: Stanford Cancer Institute Palo Alto, Palo Alto, California

  • Obinutuzumab, Venetoclax, and Lenalidomide in Treating Patients with Relapsed or Refractory B-cell Non-Hodgkin Lymphoma

    This phase I study studies the side effects and best dose of venetoclax and lenalidomide when given together with obinutuzumab in treating patients with B-cell non-Hodgkin lymphoma that has returned after a period of improvement or not responding to treatment. Monoclonal antibodies, such as obinutuzumab, may interfere with the ability of cancer cells to grow and spread. Venetoclax may stop the growth of cancer cells by blocking some of the enzymes needed for cell growth. Drugs used in chemotherapy, such as lenalidomide, work in different ways to stop the growth of cancer cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Giving obinutuzumab, venetoclax, and lenalidomide may work better in treating patients with B-cell non-Hodgkin lymphoma.
    Location: Ohio State University Comprehensive Cancer Center, Columbus, Ohio

  • Ibrutinib and Venetoclax in Treating Patients with Relapsed or Refractory Follicular Lymphoma

    This phase I / II trial studies the side effects and best dose of ibrutinib and venetoclax and to see how well they work in treating patients with follicular lymphoma that has returned after a period of improvement or does not respond to treatment. Ibrutinib may stop the growth of cancer cells by blocking some of the enzymes needed for cell growth. Drugs used in chemotherapy, such as venetoclax, work in different ways to stop the growth of cancer cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Giving ibrutinib and venetoclax may work better in treating patients with follicular lymphoma.
    Location: 2 locations


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