Study on the Safety and Early Effectiveness of Ibrutinib and Pembrolizumab in Patients with Chronic Lymphocytic Leukemia (CLL) or Mantle Cell Lymphoma (MCL)

Sponsor: Joshua Brody

Sponsor score: 0
Inactive

ClinicalTrials ID:NCT03153202

Provider View

This clinical trial is testing a new combination of two drugs, ibrutinib and pembrolizumab, to see if they are safe and effective in treating patients with Chronic Lymphocytic Leukemia (CLL) or Mantle Cell Lymphoma (MCL). The study will monitor for side effects and assess how well the combination works against these cancers.

Patient Parameters

Program Overview

The purpose of this study is to find the best dose for the combination of two drugs, ibrutinib and pembrolizumab, and to see if they work well together in treating Chronic Lymphocytic Leukemia (CLL) and Mantle Cell Lymphoma (MCL). Ibrutinib is a drug that blocks a protein important for the growth of certain blood cancer cells, and pembrolizumab is an antibody that helps the immune system fight cancer. This is the first time these drugs are being used together, and they are considered experimental for this combination. The study will check for any side effects and see if the combination is effective in treating the cancers.

Description

This study is divided into two phases. In Phase 1, researchers will test the safety of different doses of ibrutinib and pembrolizumab in patients with Mantle Cell Lymphoma (MCL) and Chronic Lymphocytic Leukemia (CLL) to find the best dose for future studies. In Phase 2A, the study will look at how well the combination works compared to past data on ibrutinib alone. All patients will start with ibrutinib for 28 days, followed by cycles of treatment where pembrolizumab is given by IV on the first day of each cycle, and ibrutinib is taken daily by mouth. The study aims to see if the combination is safe, well-tolerated, and more effective than ibrutinib alone. Researchers will also look at how long the response lasts and the overall response rate compared to past data on ibrutinib alone.

Eligibility Criteria

Inclusion Criteria

  • Be willing and able to provide written consent to participate in the trial.
  • Be 18 years or older.
  • Have measurable disease based on specific medical criteria for CLL or MCL.
  • Be willing to provide a new or recent biopsy sample of a tumor, or an archived sample if a new one cannot be safely obtained.
  • Have a performance status of 0 or 1, meaning fully active or restricted in physically strenuous activity but ambulatory.
  • Have adequate organ function as shown by specific lab tests.
  • Women of childbearing potential must have a negative pregnancy test before starting the study and agree to use effective contraception during the study and for 120 days after the last dose.
  • Men must agree to use effective contraception during the study and for 120 days after the last dose.

Exclusion Criteria

  • Currently participating in another study or have used an investigational drug or device within 4 weeks before starting this study.
  • Have a diagnosis of immunodeficiency or are using systemic steroids or other immunosuppressive therapy within 7 days before starting the study.
  • Have a history of active tuberculosis (TB).
  • Have allergies to ibrutinib or pembrolizumab or their ingredients.
  • Have had a prior monoclonal antibody treatment within 4 weeks before starting the study or have not recovered from side effects of previous treatments.
  • Have had chemotherapy, targeted therapy, or radiation within 2 weeks before starting the study or have not recovered from side effects of previous treatments.
  • Have another progressing cancer that requires treatment, except for certain skin cancers or in situ cervical cancer.
  • Have active brain metastases or lymphomatous meningitis.
  • Have an active autoimmune disease requiring treatment in the past year.
  • Have a history of non-infectious pneumonitis.
  • Have an active infection requiring treatment.
  • Have any condition or treatment that might interfere with the study or is not in the best interest of the participant.
  • Have psychiatric or substance abuse disorders that would interfere with the study.
  • Are pregnant or breastfeeding, or planning to conceive or father children during the study and for 120 days after the last dose.
  • Have received prior therapy with anti-PD-1, anti-PD-L1, or anti-PD-L2 agents.
  • Have previously received a BTK inhibitor and had disease progression during therapy.
  • Have a known history of HIV.
  • Have active Hepatitis B or C.
  • Have received a live vaccine within 30 days before starting the study.

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