Study to Evaluate the Safety and Preliminary Efficacy of Ibrutinib and Pembrolizumab in Patients With Chronic Lymphocytic Leukemia (CLL) or Mantle Cell Lymphoma (MCL)

Part of paid clinical trials in New York, New York.

Sponsor
Joshua Brody
Study ID
NCT03153202
Phase
PHASE1/PHASE2
Status
Active Not Recruiting

Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - 99 Years
Healthy Volunteers
Not accepted

Interventions

  • Ibrutinib — DRUG
    once daily oral intake ibrutinib
  • Pembrolizumab — DRUG
    200mg IV pembrolizumab on Day 1 of each cycle

Study Details

The purpose of this study is to determine the most appropriate dose for the combination of ibrutinib and pembrolizumab and to see if the combination is active for the disease. The study will monitor for any side effects and if the combination of ibrutinib and pembrolizumab works in the cancers being studied. There will be 2 experimental drugs given to the subject in this study. One experimental drug used in this study is called ibrutinib and the second is called pembrolizumab. This is the first time that ibrutinib will be used in combination with pembrolizumab. This combination is considered experimental. Experimental means that it is still being tested to see if it is safe and effective. Ibrutinib is a new drug known as a 'Bruton's Tyrosine Kinase (BTK) inhibitor'. Ibrutinib blocks an enzyme (protein) that affects how certain types of blood cancer cells grow and survive. Blocking this enzyme is a very important mechanism in killing blood cancer cells. Ibrutinib has been approved in the United States, Israel, and the European Union for use in adult patients with mantle cell lymphoma (MCL) and adult patients with chronic lymphocytic leukemia (CLL) who have received at least one prior therapy. Pembrolizumab is an antibody (a type of human protein) that is being tested to see if it will allow the body's immune system to work against tumor cells. Pembrolizumab is approved for use by the U.S. Food and Drug Administration (FDA) for the treatment of adult patients with melanoma (skin cancer) who have received prior treatments. Pembrolizumab is not FDA approved to treat patients with chronic lymphocytic leukemia \[CLL\] and mantle cell lymphoma \[MCL\].

Key Dates

Start date
Jul 14, 2017
Status verified
Nov 2024
Primary completion
Nov 30, 2025
Completion
Nov 30, 2026

Study Design

Enrollment
23 participants (estimated)
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Participants with CLL
    Participants with relapsed/ refractory Chronic Lymphocytic Leukemia (CLL) or 17p- CLL
  • Experimental: Participants with MCL
    Participants with relapsed/ refractory Mantle Cell Lymphoma (MCL)

Primary Outcome Measure

Dose Limiting Toxicity (DLT) [ Time Frame: up to 3 months ]

Locations (1)

FacilityCityStateZIPSite coordinators
Icahn School of Medicine at Mount SinaiNew YorkNew York10029-

Find similar trials in New York, NY

By condition
Leukemia (other)
By specialty
OncologyBlood cancer
By research site
Icahn School of Medicine at Mount Sinai· New York, NY

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