Clinical Trials Using Venetoclax

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 130
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  • Ibrutinib and Obinutuzumab with or without Venetoclax in Treating Patients with Chronic Lymphocytic Leukemia

    This phase III trial studies how well ibrutinib and obinutuzumab with or without venetoclax work in treating patients with chronic lymphocytic leukemia. Ibrutinib may stop the growth of cancer cells by blocking some of the enzymes needed for cell growth. Obinutuzumab is a monoclonal antibody that may interfere with the ability of cancer cells to grow and spread. Chemotherapy drugs, 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, obinutuzumab, and venetoclax may work better than giving ibrutinib and obinutuzumab in treating patients with chronic lymphocytic leukemia.
    Location: 850 locations

  • Testing The Addition of a New Anti-cancer Drug, Venetoclax, to the Usual Treatment (Ibrutinib and Obinutuzumab) in Untreated, Older Patients with Chronic Lymphocytic Leukemia

    This phase III trial compares adding a new anti-cancer drug (venetoclax) to the usual treatment (ibrutinib plus obinutuzumab) in older patients with chronic lymphocytic leukemia who have not received previous treatment. The addition of venetoclax to the usual treatment might prevent chronic lymphocytic leukemia from returning. This trial also will investigate whether patients who receive ibrutinib plus obinutuzumab plus venetoclax and have no detectable chronic lymphocytic leukemia after 1 year of treatment, can stop taking ibrutinib. Ibrutinib may stop the growth of cancer cells by blocking some of the enzymes needed for cell growth. Immunotherapy with obinutuzumab may induce changes in body’s immune system and may interfere with the ability of cancer cells to grow and spread. 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 obinutuzumab with venetoclax may work better at treating chronic lymphocytic leukemia compared to ibrutinib and obinutuzumab.
    Location: 758 locations

  • Testing the Addition of a New Anti-cancer Drug, Venetoclax, to Usual Chemotherapy for High Grade B-cell Lymphomas

    This phase II / III trial tests whether it is possible to decrease the chance of high-grade B-cell lymphomas returning or getting worse by adding a new drug, venetoclax to the usual combination of drugs used for treatment. Venetoclax may stop the growth of cancer cells by blocking a protein called Bcl-2. Drugs used in usual chemotherapy, such as rituximab, cyclophosphamide, doxorubicin, vincristine, prednisone, 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 together with usual chemotherapy may work better than usual chemotherapy alone in treating patients with high-grade B-cell lymphomas, and may increase the chance of cancer going into remission and not returning.
    Location: 599 locations

  • Testing the Effects of Early Treatment with Venetoclax and Obinutuzumab versus Delayed Treatment with Venetoclax and Obinutuzumab for Newly Diagnosed Patients with High-Risk Chronic Lymphocytic Leukemia or Small Lymphocytic Lymphoma Who Do Not Have Symptoms, the EVOLVE CLL / SLL Study

    This phase III trial compares early treatment with venetoclax and obinutuzumab versus delayed treatment with venetoclax and obinutuzumab in patients with newly diagnosed high-risk chronic lymphocytic leukemia or small lymphocytic lymphoma. Venetoclax may stop the growth of cancer cells by blocking some of the enzymes needed for cell growth. Immunotherapy with monoclonal antibodies, such as obinutuzumab, may help the body’s immune system attack the cancer, and may interfere with the ability of tumor cells to grow and spread. Starting treatment with the venetoclax and obinutuzumab early (before patients have symptoms) may have better outcomes for patients with chronic lymphocytic leukemia or small lymphocytic lymphoma compared to starting treatment with the venetoclax and obinutuzumab after patients show symptoms.
    Location: 20 locations

  • Study of Biomarker-Based Treatment of Acute Myeloid Leukemia

    This screening and multi-sub-study Phase 1b / 2 trial will establish a method for genomic screening followed by assigning and accruing simultaneously to a multi-study "Master Protocol (BAML-16-001-M1)." The specific subtype of acute myeloid leukemia will determine which sub-study, within this protocol, a participant will be assigned to evaluate investigational therapies or combinations with the ultimate goal of advancing new targeted therapies for approval. The study also includes a marker negative sub-study which will include all screened patients not eligible for any of the biomarker-driven sub-studies.
    Location: 17 locations

  • A Study of Oral LOXO-305 in Patients With Previously Treated CLL / SLL or NHL

    This is an open-label, multi-center Phase 1 / 2 study of oral LOXO-305 in patients with CLL / SLL and NHL who have failed or are intolerant to standard of care.
    Location: 18 locations

  • Study of AZD5991 in Relapsed or Refractory Haematologic Malignancies.

    This study is a multicenter, open-label, nonrandomized, sequential group, dose-escalation study to assess safety, tolerability, pharmacokinetics and preliminary anti-tumor activity of ascending doses of AZD5991 in subjects with relapsed or refractory hematologic malignancies Part 1 of the study is monotherapy dose escalation. Part 2 of the study is monotherapy expansion groups for relapsed / refractory chronic lymphocytic leukaemia (CLL), AML / myelodysplastic syndromes (MDS), and multiple myeloma (MM) Part 3 is a sequential, dose-escalation study of the combination of AZD5991 and venetoclax in subjects with relapsed / refractory AML / MDS
    Location: 12 locations

  • Myeloma-Developing Regimens Using Genomics (MyDRUG)

    The MyDRUG study is a type of Precision Medicine trial to treat patients with drugs targeted to affect specific genes that are mutated as part of the disease. Mutations in genes can lead to uncontrolled cell growth and cancer. Patients with a greater than 30% mutation to any of the following genes; CDKN2C, FGFR3, KRAS, NRAS, BRAF V600E, IDH2 or T(11;14) can be enrolled to one of the treatment arms. These arms have treatments specifically directed to the mutated genes. Patients that do not have a greater than 30% mutation to the genes listed can be enrolled to a non-actionable treatment arm. The genetic sequencing of the patient's tumor is required via enrollment to the MMRF002 study: Clinical-grade Molecular Profiling of Patients with Multiple Myeloma and Related Plasma Cell Malignancies. (NCT02884102).
    Location: 12 locations

  • A Study of Venetoclax and Dexamethasone Compared With Pomalidomide and Dexamethasone in Participants With Relapsed or Refractory Multiple Myeloma

    A study designed to evaluate the safety and efficacy of venetoclax plus dexamethasone (VenDex) compared with pomalidomide plus dexamethasone (PomDex) in participants with t(11;14)-positive Relapsed or Refractory Multiple Myeloma.
    Location: 12 locations

  • IMGN632 as Monotherapy or With Venetoclax and / or Azacitidine for Patients With CD123-Positive Acute Myeloid Leukemia

    This is an open-label, multicenter, Phase 1b / 2 study to determine the safety and tolerability of IMGN632 and assess the antileukemia activity of IMGN632 when administered in combination with azacitidine and / or venetoclax in patients with relapsed and frontline CD123-positive AML, and antileukemia activity of IMGN632 when administered as monotherapy in patients with MRD+ AML after frontline treatment.
    Location: 10 locations

  • Venetoclax and Vincristine Liposomal in Treating Patients with Relapsed or Refractory T-cell or B-cell Acute Lymphoblastic Leukemia

    This phase Ib / II trial studies the side effects and best dose of venetoclax and how well it works when given together with vincristine liposomal in treating patients with T-cell or B-cell acute lymphoblastic leukemia that has come back (recurrent) or does not respond to treatment (refractory). Venetoclax may stop the growth of cancer cells by blocking some of the enzymes needed for cell growth. Chemotherapy drugs, such as vincristine liposomal, 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 together with vincristine liposomal may work better in treating patients with acute lymphoblastic leukemia compared to vincristine liposomal alone.
    Location: 9 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: 9 locations

  • APR-246 in Combination With Venetoclax and Azacitidine in TP53-Mutant Myeloid Malignancies

    This clinical trial is a Phase I, open-label, dose-finding and cohort expansion study to determine the safety and preliminary efficacy of APR-246 in combination with venetoclax and azacitidine in patients with myeloid malignancies.
    Location: 8 locations

  • Zanubrutinib, Obinutuzumab, and Venetoclax in Treating Patients with Previously Untreated Chronic Lymphocytic Leukemia or Small Lymphocytic Lymphoma and Mantle Cell Lymphoma

    This phase II trial studies how well zanubrutinib, obinutuzumab, and venetoclax work in treating patients with previously untreated chronic lymphocytic leukemia or small lymphocytic lymphoma and mantle cell lymphoma. Zanubrutinib may stop the growth of cancer cells by blocking some of the enzymes needed for cell growth. Venetoclax may stop the growth of cancer cells by blocking Bcl-2, a protein needed for cancer cell growth. Immunotherapy with monoclonal antibodies, such as obinutuzumab, may induce changes in body’s immune system and may interfere with the ability of tumor cells to grow and spread. Giving zanubrutinib, obinutuzumab, and venetoclax together may work better in treating patients with chronic lymphocytic leukemia, small lymphocytic lymphoma and mantle cell lymphoma compared to standard therapy, including antibody therapy (a treatment that targets cancer cells) plus chemotherapy.
    Location: 8 locations

  • Study to Assess the Efficacy and Safety of Ublituximab Plus Umbralisib in Combination With Venetoclax in Subjects With CLL

    ULTRA-V: Phase 2 Study to Assess the Efficacy and Safety of Ublituximab in Combination with Umbralisib and Venetoclax (U2-V) in Subjects with Chronic Lymphocytic Leukemia (CLL)
    Location: 10 locations

  • FORRDuvelisib and Venetoclax in Treating Patients with Richter's Syndrome or Relapsed or Refractory Chronic Lymphocytic Leukemia or Small Lymphocytic Lymphoma

    This phase I / II trial studies the side effects and best dose of venetoclax when given together with duvelisib 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, or Richter's syndrome. Duvelisib may stop the growth of cancer cells by blocking some of the enzymes needed for cell growth. Venetoclax targets a protein called BCL-2, which helps cancer cells survive. Combining duvelisib and venetoclax may be able to prevent tumor from growing.
    Location: 8 locations

  • Study of Ibrutinib Combined With Venetoclax in Subjects With Mantle Cell Lymphoma (SYMPATICO)

    This Phase 3 multinational, randomized, double-blind study is designed to compare the efficacy and safety of the combination of ibrutinib and venetoclax vs. ibrutinib and placebo in subjects with MCL.
    Location: 8 locations

  • A Study Evaluating Venetoclax in Combination With Azacitidine in Participants 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 participants with treatment-naïve higher-risk MDS comprising a dose-escalation portion and a safety expansion portion.
    Location: 8 locations

  • Assessing Minimal Residual Disease to Minimize Exposure in Patients with Chronic Lymphocytic Leukemia or Small Lymphocytic Leukemia Who Have Been Treated with Venetoclax, Veneto-STOP Study

    This phase II trial assesses minimal residual disease to minimize exposure in patients with chronic lymphocytic leukemia or small lymphocytic leukemia who have been treated with venetoclax. Stopping treatment with venetoclax in MRD-negative chronic lymphocytic leukemia or small lymphocytic leukemia patients could help prevent the serious side effects that can occur during long-term treatment with this drug. This trial may help researchers find out whether patients who are currently receiving treatment with venetoclax can stop treatment and remain off-treatment for at least 12 months, if they are free of residual disease (MRD-negative) when they stop treatment.
    Location: 10 locations

  • Study of Acalabrutinib (ACP-196) in Combination With Venetoclax (ABT-199), With and Without Obinutuzumab (GA101) Versus Chemoimmunotherapy for Previously Untreated CLL

    The purpose of this study is to evaluate the efficacy and safety of acalabrutinib in combination with venetoclax and acalabrutinib in combination with venetoclax with and without obinutuzumab compared to chemoimmunotherapy in subjects with previously untreated CLL.
    Location: 7 locations

  • A Study Comparing Zanubrutinib With Bendamustine Plus Rituximab in Participants With Previously Untreated CLL or SLL

    To compare efficacy between zanubrutinib versus bendamustine and rituximab in patients with previously untreated CLL / SLL, as measured by progression free survival.
    Location: 7 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 (recurrent) or does not respond to treatment (refractory). Drugs used in chemotherapy, such as bendamustine 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. 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. Venetoclax may kill cancer cells and / or help make cancer treatments more effective by blocking a protein called Bcl-2, that helps cancer cells survive and resist the effects of cancer treatments. Giving bendamustine hydrochloride, rituximab, ibrutinib, and venetoclax may work better in treating patients with mantle cell lymphoma.
    Location: 7 locations

  • Trial of DFP-10917 vs Non-Intensive or Intensive Reinduction for AML Patients in 2nd / 3rd / 4th Salvage

    Phase III, multicenter, randomized study with two arms (1:1 ratio) enrolling patients with AML relapsed / refractory after 2, 3, or 4 prior induction regimens: Experimental arm: DFP-10917 14-day continuous intravenous (IV) infusion at a dose of 6 mg / m² / day followed by a 14-day resting period per 28-day cycles. Control arm: Non-Intensive Reinduction (LoDAC, Azacitidine, Decitabine, Venetoclax Combination Regimens) or Intensive Reinduction (High and Intermediate Dose Cytarabine Regimens), depending on the patient's prior induction treatment.
    Location: 6 locations

  • A Study to Assess Safety and Efficacy of Venetoclax in Combination With Gilteritinib in Participants With Relapsed / Refractory Acute Myeloid Leukemia

    A dose-escalation study evaluating the safety, tolerability, pharmacokinetics (PK) and efficacy of venetoclax, in combination with gilteritinib, in participants with relapsed or refractory (R / R) acute myeloid leukemia (AML) who have failed to respond to, and / or have relapsed or progressed after at least 1 prior therapy.
    Location: 6 locations

  • Acalabrutinib, Venetoclax, and Obinutuzumab in Treating Patients with Chronic Lymphocytic Leukemia or Small Lymphocytic Lymphoma

    This phase II trial studies how well acalabrutinib, venetoclax, and obinutuzumab work in treating patients with chronic lymphocytic leukemia or small lymphocytic lymphoma. Acalabrutinib may stop the growth of cancer cells by blocking some of the enzymes needed for cell growth. 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. Immunotherapy with monoclonal antibodies, such as obinutuzumab, may help the body’s immune system attack the cancer, and may interfere with the ability of tumor cells to grow and spread. Giving acalabrutinib, venetoclax, and obinutuzumab may work better in treating patients with chronic lymphocytic leukemia or small lymphocytic lymphoma.
    Location: 6 locations


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