Clinical Trials Using Idelalisib

Clinical trials are research studies that involve people. The clinical trials on this list are studying Idelalisib. 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 1-6 of 6
  • Idelalisib in Treating Participants with Indolent or Transformed Indolent Non-Hodgkin Lymphoma after Autologous Stem Cell Transplant

    This phase II trial studies the side effects of idelalisib and how well it works in treating participants with indolent or transformed indolent non-Hodgkin lymphoma after undergoing autologous stem cell transplant. Idelalisib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth.
    Location: 2 locations

  • Pembrolizumab Alone or with Idelalisib or Ibrutinib in Treating Patients with Relapsed or Refractory Chronic Lymphocytic Leukemia or Other Low-Grade B-Cell Non-Hodgkin Lymphomas

    This phase II trial studies how well pembrolizumab alone or with idelalisib or ibrutinib works in treating patients with chronic lymphocytic leukemia or other low-grade B-cell non-Hodgkin lymphomas that have returned after a period of improvement or have not responded to treatment. Immunotherapy with monoclonal antibodies, such as pembrolizumab, may help the body's immune system attack the cancer, and may interfere with the ability of tumor cells to grow and spread. Idelalisib and ibrutinib may stop the growth of cancer cells by blocking some of the enzymes needed for cell growth. Giving pembrolizumab alone or with idelalisib or ibrutinib may be an effective treatment in patients with chronic lymphocytic leukemia or other low-grade B-cell non-Hodgkin lymphomas.
    Location: 2 locations

  • Serial Measurements of Molecular and Architectural Responses to Therapy (SMMART) PRIME Trial

    This phase Ib trial determines if samples from a patient’s cancer can be tested to find combinations of drugs that provide clinical benefit for the kind of cancer the patient has. This study is also being done to understand why cancer drugs can stop working and how different cancers in different people respond to different types of therapy.
    Location: OHSU Knight Cancer Institute, Portland, Oregon

  • Rituximab, Idelalisib, and Venetoclax in Treating Participants with Relapsed or Refractory Chronic Lymphocytic Leukemia or Small Lymphocytic Lymphoma

    This phase I trial studies the best dose and side effects of idelalisib and venetoclax when given together with rituximab for the treatment of patients with chronic lymphocytic leukemia or small lymphocytic lymphoma that has come back (relapsed) or does not respond to treatment (refractory). Rituximab is a monoclonal antibody that may interfere with the ability of cancer cells to grow and spread. Idelalisib may stop the growth of tumor 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 tumor cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Giving rituximab, idelalisib and venetoclax may work better at treating relapsed or refractory chronic lymphocytic leukemia or small lymphocytic lymphoma.
    Location: Virginia Commonwealth University / Massey Cancer Center, Richmond, Virginia

  • Dose Optimization Study of Idelalisib in Follicular Lymphoma

    The primary objective of this study is to establish a safe and effective dosing regimen of idelalisib in participants with relapsed or refractory follicular lymphoma (FL) who have no other therapeutic options.
    Location: See Clinical Trials.gov

  • Dose Escalation and Dose Expansion Study of Tirabrutinib in Combination With Other Targeted Anti-cancer Therapies in Adults With B-cell Malignancies

    The primary objectives of this study are to evaluate the safety, tolerability, pharmacokinetics (PK), pharmacodynamics, and preliminary efficacy of tirabrutinib (ONO / GS-4059) in combination with other targeted anti-cancer therapies and to evaluate the long-term safety of tirabrutinib as a monotherapy and in combination with other targeted anti-cancer therapies in adults with relapsed or refractory B-cell lymphoproliferative malignancies. This study consists of three parts: Dose Escalation, Dose Expansion, and Long-term Safety Monitoring. During the Dose Escalation phase, participants will be sequentially enrolled in a standard 3 + 3 dose escalation study design, to receive oral tirabrutinib combined with idelalisib entospletinib + / - obinutuzumab. The Dose Expansion Phase will enroll additional participants with a single B-cell lymphoproliferative malignancy disease type to further evaluate efficacy, safety, tolerability, PK, and pharmacodynamics. The Long-term Safety Monitoring phase will evaluate the long-term safety of tirabrutinib both as a monotherapy and in combination with other anti-cancer therapies. As of Amendment 9, all participants currently on the study who have no clinical evidence of disease progression will transition into long-term safety monitoring. Participants from the ongoing Study GS-US-401-1787 and participants who came off Study GS-US-401-1757 and Study GS-US-401-1787 but continued to receive treatment via named patient use (or individual expanded use) will be enrolled into the long-term safety monitoring group (Group VI). Participants enrolled in Group VI will continue the same treatment regimen in Study GS-US-401-1787 or named patient use (or individual expanded use). As of Protocol Amendment 8, the maximum treatment duration for any participant is an additional 6 years from the date of this amendment (ie. until November 2025). As of Amendment 9, entospletinib will be provided until 31 December 2020 to participants who are currently receiving entospletinib. Participants treated with entospletinib as part of a combination regimen with tirabrutinib will stop receiving entospletinib by 31 December 2020 but may continue to be treated with tirabrutinib monotherapy. Idelalisib will be provided as 50 mg tablets until 31 December 2020 and 100 mg tablets until study completion. Participants assigned to the 50 mg tablet will be given the option, at the investigator's discretion, to switch to 100 mg once daily idelalisib dose.
    Location: See Clinical Trials.gov