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 78
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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: 763 locations

  • Ibrutinib before and after Stem Cell Transplant in Treating Patients with Relapsed or Refractory Diffuse Large B-cell Lymphoma

    This randomized phase III trial studies ibrutinib to see how well it works compared to placebo when given before and after stem cell transplant in treating patients with diffuse large B-cell lymphoma that has returned after a period of improvement (relapsed) or does not respond to treatment (refractory). Before transplant, stem cells are taken from patients and stored. Patients then receive high doses of chemotherapy to kill cancer cells and make room for healthy cells. After treatment, the stem cells are then returned to the patient to replace the blood-forming cells that were destroyed by the chemotherapy. Ibrutinib is a drug that may stop the growth of cancer cells by blocking a protein that is needed for cell growth. It is not yet known whether adding ibrutinib to chemotherapy before and after stem cell transplant may help the transplant work better in patients with relapsed or refractory diffuse large B-cell lymphoma.
    Location: 237 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: 25 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: 16 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: 16 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: 13 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: 11 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: 8 locations

  • A Study of CA-4948 in Patients With Relapsed or Refractory Hematologic Malignancies

    This is a multi-center, open-label trial to evaluate oral administration of CA-4948 in adult patients with relapsed / refractory hematologic malignancies. Part A will evaluate escalating doses of CA-4948 either as monotherapy (Part A1) or in combination with ibrutinib for non- Hodgkin's Lymphoma (NHL), macroglobulinemia / lymphoplasmacytic lymphoma (WM / LPL) and chronic lymphocytic leukemia (CLL) / small lymphocytic lymphoma (SLL) (Part A2). Once the combination dose has been determined, Part B will comprise an expansion phase to assess efficacy (CR rate) and safety of the RP2D of CA-4948 and ibrutinib in 4 Non-Hodgkin Lymphoma (NHL) disease-specific cohorts: - Cohort 1 - Marginal zone lymphoma (MZL) - Cohort 2 - activated B-cell (ABC) diffuse large B-cell lymphoma (DLBCL) or extranodal subtypes: Leg-, testicular-, or not otherwise specified (NOS)-type - Cohort 3 - Primary central nervous system lymphoma (PCNSL) - Cohort 4 - Patients receiving ibrutinib monotherapy who have developed adaptive, secondary resistance. Indications include: - Mantle Cell Lymphoma (MCL), MZL, CLL / SLL, or WM / LPL - Indications for which ibrutinib is National Comprehensive Cancer Network (NCCN)-listed (e.g., PCNSL) - Patients with NHL and known myddosome mutations - Patients may be candidates for maintaining ibrutinib while CA-4948 will be added for resistance reversal. A brief gap of ibrutinib therapy of <3 weeks is acceptable.
    Location: 10 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

  • Ibrutinib and Rituximab for the Treatment of Treatment Naive Marginal Zone Lymphoma

    This phase III trial studies how well ibrutinib and rituximab work compared with rituximab alone in treating patients with marginal zone lymphoma who have not received prior treatment for the disease (treatment naive). Ibrutinib may stop the growth of cancer cells by blocking some of the enzymes needed for cell growth. Rituximab is a monoclonal antibody that may interfere with the ability of cancer cells to grow and spread. Giving ibrutinib and rituximab may work better in treating patients with marginal zone lymphoma compared to rituximab alone.
    Location: 12 locations

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

    This study is designed to compare the overall response rate of zanubrutinib versus ibrutinib in participants with relapsed / refractory chronic lymphocytic leukemia or small lymphocytic 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 (recurrent) or does not respond to treatment (refractory). Ibrutinib may stop the growth of cancer cells by blocking some of the enzymes needed for cell growth. Rituximab is a monoclonal antibody that may interfere with the ability of cancer 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 (recurrent) or does not respond to treatment (refractory). Copanlisib and ibrutinib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth.
    Location: 7 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: 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 (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

  • 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: 7 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 (recurrent) or does not respond to treatment (refractory). Copanlisib and ibrutinib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth.
    Location: 6 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: 7 locations

  • A Safety and Efficacy Trial of JCAR017 Combinations in Subjects With Relapsed / Refractory B-cell Malignancies (PLATFORM)

    This is a global, open-label, multi-arm, parallel multi-cohort, multi-center, Phase 1 / 2 study to determine the safety, tolerability, PK, efficacy and patient-reported quality of life of JCAR017 in combination with various agents. This protocol is intended to evaluate various drug combinations with JCAR017, as separate arms, over the life of the protocol, using the same objectives. Each combination will be evaluated separately (ie, the intention is not to compare between combinations) for the purposes of the objectives, trial design, and statistical analysis. The following combinations will be tested: Arm A: JCAR017 in combination with durvalumab Arm B: JCAR017 in combination with CC-122 (avadomide) Arm C: JCAR017 in combination with CC-220 (iberdomide) Arm D: JCAR017 in combination with ibrutinib Additional arms will be added by way of amendment once combination agents have been selected. The study will consist of 2 parts: dose finding (Phase 1) and dose expansion (Phase 2). Dose expansion may occur in one or more arms.
    Location: 7 locations

  • A Study of Mavorixafor in Combination With Ibrutinib in Participants With Waldenstrom's Macroglobulinemia (WM) Whose Tumors Express Mutations in MYD88 and CXCR4

    The primary objective of the study is to establish a pharmacologically active dose of mavorixafor in combination with ibrutinib based on pooled safety, clinical response, pharmacokinetic (PK) and pharmacodynamic (PD) data to select the recommended dose for a randomized registrations trial.
    Location: 4 locations

  • VAY736 in Combination With Ibrutinib in Patients With CLL on Ibrutinib

    Patients enrolled to the study will have chronic lymphocytic leukemia (CLL) and are actively receiving ibrutinib. Patients will have either been receiving ibrutinib for one year without having had a complete response or patients will have developed a resistance mutation to ibrutinib. This study will have two parts, a dose escalation part and a dose expansion part. In the dose escalation part, the maximum tolerated dose (MTD) of the combination of VAY736 with ibrutinib will be determined. Once determined, the dose expansion part of the study will begin.
    Location: 4 locations

  • Ibrutinib in Treating Patients with Relapsed or Refractory Classical Hodgkin Lymphoma

    This phase II trial studies how well ibrutinib works in treating patients with classical Hodgkin lymphoma that has come back after a period of improvement (recurrent) or no longer responds to treatment (refractory). Ibrutinib may stop the growth of cancer cells by blocking some of the enzymes needed for cell growth.
    Location: 4 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


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