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NCT03153202 · ClinicalTrials.gov registry record · Phase 1
Study to Evaluate the Safety and Preliminary Efficacy of Ibrutinib and Pembrolizumab in Patients With Chronic Lymphocytic Leukemia (CLL) or Mantle Cell Lymphoma (MCL)
A Phase 1 study of Chronic Lymphocytic Leukemia and Mantle Cell Lymphoma, sponsored by Joshua Brody.
- Active
- Registry status
- Phase 1
- Development phase
- 23
- Enrollment target
- 1
- Study location
NCT03153202 is a Phase 1 study of Chronic Lymphocytic Leukemia and Mantle Cell Lymphoma that is active but no longer recruiting, run by Joshua Brody. The registered enrollment target is 23 participants, below the 182-participant average among 187 other Chronic Lymphocytic Leukemia trials with a reported enrollment target (87% lower). The trial reports 1 study location across 1 state.
The verdict
NCT03153202, a Phase 1 study of Chronic Lymphocytic Leukemia and Mantle Cell Lymphoma, is active but no longer recruiting, sponsored by Joshua Brody.
- ACTIVE NOT RECRUITING
- Registry status
- Phase 1
- Development phase
- 23 participants
- Enrollment target
- 1
- Study location
Study Summary
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 \[MCL\].
Conditions Studied
Interventions
- DRUG Pembrolizumab
- DRUG Ibrutinib
Study Locations (1)
New York
- Icahn School of Medicine at Mount Sinai - New York
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 23 participants |
| Start Date | 2017-07-14 |
| Est. Completion | 2026-11 |
| Phase | Phase 1 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT03153202
The ClinicalTrials.gov registry entry for NCT03153202 describes a study currently listed as active not recruiting, categorized as Phase 1. The registered enrollment target is 23 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 182-participant average among 187 other Chronic Lymphocytic Leukemia trials with a reported enrollment target (87% lower). The listed sponsor is Joshua Brody, which has 2 total studies on file at ClinicalTrials.gov.
The record links to 2 conditions, with Chronic Lymphocytic Leukemia appearing as the primary indexed condition, and to 2 interventions - of which Pembrolizumab is the first listed.
NCT03153202 reports 1 study location spanning 1 distinct geographic area - top geographies include New York.
Frequently Asked Questions
What is clinical trial NCT03153202 about?
NCT03153202 is a clinical study titled "Study to Evaluate the Safety and Preliminary Efficacy of Ibrutinib and Pembrolizumab in Patients With Chronic Lymphocytic Leukemia (CLL) or Mantle Cell Lymphoma (MCL)". 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...
What is the current status of trial NCT03153202?
This trial is currently active not recruiting. It is a Phase 1 study. The enrollment target is 23 participants. The study started on 2017-07-14. Estimated completion is 2026-11.
What conditions does trial NCT03153202 study?
This clinical trial studies the following conditions: Chronic Lymphocytic Leukemia, Mantle Cell Lymphoma.
What interventions are being tested in trial NCT03153202?
The interventions under investigation include: Pembrolizumab (DRUG), Ibrutinib (DRUG).
Who is sponsoring clinical trial NCT03153202?
This trial is sponsored by Joshua Brody, which has 2 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT03153202 being conducted?
This trial has 1 study location across New York. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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