Clinical Trials Using Ibrutinib

Clinical trials are research studies that involve people. The clinical trials on this list are studying Ibrutinib. 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 82
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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. 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. 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, obinutuzumab and venetoclax may work better in treating patients with chronic lymphocytic leukemia.
    Location: 720 locations

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

    This phase III trial studies how well ibrutinib and obinutuzumab with or without venetoclax work in treating older patients with untreated chronic lymphocytic leukemia. 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: 646 locations

  • Study Evaluating Safety and Efficacy of JCAR017 in Subjects With Relapsed or Refractory Chronic Lymphocytic Leukemia (CLL) or Small Lymphocytic Lymphoma (SLL)

    This is a Phase 1 / 2, open-label, multicenter study to determine the efficacy and safety of JCAR017 in adult subjects with relapsed or refractory CLL or SLL. The study will include a Phase 1 part to determine the recommended dose of JCAR017 monotherapy in subjects with relapsed or refractory CLL or SLL, followed by a Phase 2 part to further assess the efficacy and safety of JCAR017 monotherapy treatment at the recommended dose. A separate Phase 1 cohort will assess the combination of JCAR017 and concurrent ibrutinib. In all subjects, the safety, efficacy, and pharmacokinetics (PK) of JCAR017 will be evaluated.
    Location: 18 locations

  • Ibrutinib, Rituximab, Etoposide, Prednisone, Vincristine Sulfate, Cyclophosphamide, and Doxorubicin Hydrochloride in Treating Patients with HIV-Positive Stage II-IV Diffuse Large B-Cell Lymphomas

    This phase I trial studies the side effect and best dose of ibrutinib in combination with rituximab, etoposide, prednisone, vincristine sulfate, cyclophosphamide, and doxorubicin hydrochloride in treating patients with human immunodeficiency virus (HIV)-positive stage II-IV diffuse large B-cell lymphomas. Ibrutinib 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 ibrutinib and etoposide, prednisone, vincristine sulfate, cyclophosphamide, and doxorubicin hydrochloride may work better in treating patients with HIV-positive diffuse large B-cell lymphomas.
    Location: 14 locations

  • A Study of Ruxolitinib vs Best Available Therapy (BAT) in Patients With Steroid-refractory Chronic Graft vs. Host Disease (GvHD) After Bone Marrow Transplantation (REACH3)

    The purpose of this study is to assess the efficacy of ruxolitinib against best available therapy in participants with steroid-refractory chronic graft-versus-host disease (SR cGvHD).
    Location: 15 locations

  • A Study to Evaluate Ibrutinib Combination Therapy in Patients With Selected Gastrointestinal and Genitourinary Tumors

    The purpose of this study is to evaluate the safety, tolerability, and efficacy of single agent ibrutinib or the combination treatments of ibrutinib with everolimus, paclitaxel, docetaxel, pembrolizumab or cetuximab in selected advanced gastrointestinal and genitourinary tumors.
    Location: 9 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: 9 locations

  • Ibrutinib with or without Cirmtuzumab in Treating Patients with B-Cell Lymphoid Malignancies

    This phase Ib / II trial studies the side effects and best dose of cirmtuzumab when given together with ibrutinib and to see how well they work in treating patients with B-cell lymphoid malignancies. Immunotherapy with cirmtuzumab, may induce changes in body’s immune system and may interfere with the ability of tumor cells to grow and spread. Ibrutinib may stop the growth of cancer cells by blocking some of the enzymes needed for cell growth. It is not yet known whether giving ibrutinib with or without cirmtuzumab may work better in treating patients with B-cell lymphoid malignancies.
    Location: 10 locations

  • Abexinostat and Ibrutinib in Treating Patients with Recurrent or Refractory Diffuse Large B-cell Lymphoma or Mantle Cell Lymphoma

    This phase I trial studies the side effects and best dose of abexinostat and to see how well it works when given together with ibrutinib in treating patients with diffuse large B-cell lymphoma or mantle cell lymphoma that has come back (recurrent) or does not respond to treatment (refractory). Abexinostat blocks a protein called histone deacetylase (HDAC), and slows the growth of cancer cells. Ibrutinib blocks a protein called Bruton tyrosine kinase (BTK), which has been shown to be highly active in lymphoma, and may cause cancer cells to die. Giving abexinostat and ibrutinib together may boost their effectiveness and limit or stop the growth of cancer cells in patients with diffuse large B-cell lymphoma or mantle cell lymphoma.
    Location: 7 locations

  • Ibrutinib, Rituximab, and Lenalidomide in Treating Patients with Refractory or Recurrent, Primary or Secondary Central Nervous System Lymphoma

    This phase Ib trial studies the side effects and best dose of ibrutinib when given together with rituximab and lenalidomide in treating patients with primary or secondary central nervous system lymphoma that has come back or does not respond to treatment. Ibrutinib may stop the growth of cancer cells by blocking some of the enzymes needed for cell growth. Immunotherapy with rituximab, may induce changes in body’s immune system and may interfere with the ability of tumor cells to grow and spread. 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. This study is being done to find out if giving ibrutinib, rituximab, and lenalidomide is safer and works better in treating patients with primary or secondary central nervous system lymphoma compared to standard treatment.
    Location: 7 locations

  • Copanlisib and Ibrutinib in Treating Patients with Recurrent or Refractory Primary Central Nervous System Lymphoma

    This phase Ib / II trial studies the side effects and best dose of ibrutinib when given together with copanlisib, and to see how well they work in treating patients with primary central nervous system lymphoma that has come back or does not respond to treatment. Copanlisib and ibrutinib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth.
    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 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: 7 locations

  • Study of Ibrutinib and Rituximab in Treatment Naïve Follicular Lymphoma

    The purpose of this study is to evaluate whether the addition of ibrutinib will result in prolongation of progression-free survival (PFS) when compared with rituximab alone in treatment naïve subjects with follicular lymphoma.
    Location: 8 locations

  • Copanlisib and Ibrutinib in Treating Patients with Recurrent or Refractory Mantle Cell Lymphoma

    This phase I / II trial studies the side effects and best dose of copanlisib and ibrutinib combination and to see how well they work in treating patients with mantle cell lymphoma that has come back or does not respond to treatment. Copanlisib and ibrutinib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth.
    Location: 6 locations

  • A Study of Ixazomib and Ibrutinib in Relapsed / Refractory Mantle Cell Lymphoma

    Patients with mantle cell lymphoma (MCL) that has relapsed (come back) or refractory (progressed on treatment) will receive ixazomib and ibrutinib. Ibrutinib has been approved by the Food and Drug Administration (FDA) as treatment for patients with mantle cell lymphoma who have received at least one prior therapy. Ixazomib is in a class of medications called proteasome inhibitors. Cancer cells depend on proteasome to provide this protein metabolism (turnover) function to regulate their growth and survival. Ixazomib disrupts a cancer cells' ability to survive by blocking the proteasome and disrupting protein metabolism. This 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 the addition of ixazomib to ibrutinib chemotherapy is effective in treating people who have relapsed or refractory MCL and to examine the side effects associated with ixazomib in combination with ibrutinib.
    Location: 7 locations

  • A Safety and Efficacy Study of Ibrutinib in Pediatric and Young Adult Participants With Relapsed or Refractory Mature B-cell Non-Hodgkin Lymphoma

    The purpose of this study is to confirm that the pharmacokinetics of ibrutinib in pediatric participants is consistent with that in adults (part 1) and to assess efficacy (event-free survival [EFS]) of ibrutinib in combination with rituximab, ifosfamide, carboplatin, and etoposide (RICE) or rituximab, vincristine, ifosfamide, carboplatin, and idarubicin (RVICI) background therapy compared to RICE or RVICI background therapy alone (part 2).
    Location: 8 locations

  • Phase 1 / 2 Study of TP-0903 (an Inhibitor of AXL Kinase) in Patients With Previously Treated CLL

    TP-0903 is an inhibitor of AXL kinase. TP-0903 has shown potent inhibition of AXL kinase and other TAM family members in a biochemical kinase assay. TP-0903 demonstrates corresponding activity in cancer cell lines and mouse xenograft efficacy models. TP-0903 is shown to block cancer cell epithelial-to-mesenchymal transitions. AXL was identified as a potential therapeutic target in chronic lymphocytic leukemia (CLL). TP 0903 was shown to induce apoptosis in CLL B-cells taken directly from patients.TP-0903 was equally potent against CLL cells regardless of risk-factor. TP-0903 is a novel oral inhibitor that targets AXL kinase and reverses the mesenchymal phenotype associated with advanced cancers. TP-0903 has demonstrated profound single agent activity in CLL B cells taken directly from patients even if the patient has high risk factors (ie, 17p / P53 deletions) or progressed on other agents (ie, ibrutinib). TP-0903 is currently being evaluated in patients with refractory solid tumors (TP-0903-101). This proposed study is designed to identify the maximum tolerated dose (MTD), safety profile and recommended Phase 2 dose (RP2D) of TP-0903 in patients with previously treated CLL. Treatment cycles may be repeated if the patient continues to show benefit and if TP-0903 is reasonably well tolerated. The study will investigate the safety, pharmacokinetics, pharmacodynamics, and clinical activity of TP-0903.
    Location: 5 locations

  • Ibrutinib in Treating Patients with Refractory or Relapsed Lymphoma after Donor Stem Cell Transplant

    This phase II trial studies how well ibrutinib works in treating patients after a donor stem cell transplant for lymphoma that is not responding to treatment or has come back. Ibrutinib may stop the growth of cancer cells by blocking some of the enzymes needed for cell growth.
    Location: 5 locations

  • Ibrutinib and Obinutuzumab in Treating Patients with Relapsed or Refractory Chronic Lymphocytic Leukemia

    This randomized phase Ib trial studies the side effects and best dose of obinutuzumab when given together with ibrutinib in treating patients with chronic lymphocytic leukemia that has returned after a period of improvement (relapsed) or has not responded to previous treatment (refractory). 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. Ibrutinib may stop the growth of cancer cells by blocking some of the enzymes needed for cell growth. Giving obinutuzumab with ibrutinib may work better in treating chronic lymphocytic leukemia.
    Location: 5 locations

  • Ibrutinib with or without Methotrexate and Rituximab in Treating Patients with Refractory or Recurrent Primary or Secondary Central Nervous System Lymphoma

    This phase I / II trial studies the side effects and best dose of ibrutinib and to see how well it works when giving with or without methotrexate and rituximab in treating patients with primary or secondary central nervous system lymphoma that has not responded to previous treatment (refractory) or has come back (recurrent). Ibrutinib and methotrexate 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. Giving ibrutinib with or without methotrexate and rituximab may work better in treating patients with primary or secondary central nervous system lymphoma.
    Location: 5 locations

  • Phase 1 / 2 Dose Finding and Safety Study of Ibrutinib in Pediatric Subjects With Chronic Graft Versus Host Disease (cGVHD)

    Dose Finding and Safety Study of Ibrutinib in Pediatric Subjects with Chronic Graft Versus Host Disease (cGVHD)
    Location: 5 locations

  • Ibrutinib in Treating Patients with Relapsed Hairy Cell Leukemia

    This phase II trial studies how well ibrutinib works in treating patients with hairy cell leukemia that has returned after a period of improvement. Ibrutinib may stop the growth of cancer cells by blocking some of the enzymes needed for cell growth.
    Location: 4 locations

  • A Study of Zanubrutinib (BGB-3111) Versus Ibrutinib in Patients With Relapsed / Refractory Chronic Lymphocytic Leukemia

    This study is designed to compare the overall response rate of zanubrutinib versus ibrutinib in patients with relapsed / refractory chronic lymphocytic leukemia or small lymphocytic lymphoma.
    Location: 7 locations

  • Phase II Palbociclib +Ibrutinib in Mantle Cell Lymphoma

    The proposed study is a single-arm, multi-center, open-label phase II study of the combination of palbociclib and ibrutinib in patients with previously treated mantle cell lymphoma to evaluate the efficacy of this combination, with the primary objective of the study being to assess median PFS and the secondary objectives to include ORR, CR, DOR, OS and toxicity. Subjects will be enrolled and treated with palbociclib and ibrutinib with each cycle of therapy being 28 days. Treatment will be based on the recommended phase II dose (RP2D) from the phase I combination trial.
    Location: 4 locations

  • Ulocuplumab and Ibrutinib in Treating Patients with Mutated CXCR4 Waldenstrom Macroglobulinemia

    This phase I / II trial studies the best dose of ulocuplumab when given together with ibrutinib and to see how well they work in treating patients with mutated CXCR4 Waldenstrom macroglobulinemia. Immunotherapy with ulocuplumab, may induce changes in body’s immune system and may interfere with the ability of tumor cells to grow and spread. Ibrutinib may stop the growth of cancer cells by blocking some of the enzymes needed for cell growth. Giving ulocuplumab and ibrutinib may work better in treating patients with Waldenstrom macroglobulinemia.
    Location: 3 locations


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