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NCT03283137 · ClinicalTrials.gov registry record · Phase 1
Combination of Pembrolizumab With TGR-1202 in Patients With Relapsed/Refractory CLL and B-cell NHL
A Phase 1 study of B-Cell Non-Hodgkin Lymphoma and CLL, sponsored by University of Chicago.
- Active
- Registry status
- Phase 1
- Development phase
- 20
- Enrollment target
- 3
- Study locations
NCT03283137 is a Phase 1 study of B-Cell Non-Hodgkin Lymphoma and CLL that is active but no longer recruiting, run by University of Chicago. The registered enrollment target is 20 participants, below the 129-participant average among 24 other B-Cell Non-Hodgkin Lymphoma trials with a reported enrollment target (84% lower). The trial reports 3 study locations across 3 states.
The verdict
NCT03283137, a Phase 1 study of B-Cell Non-Hodgkin Lymphoma and CLL, is active but no longer recruiting, sponsored by University of Chicago.
- ACTIVE NOT RECRUITING
- Registry status
- Phase 1
- Development phase
- 20 participants
- Enrollment target
- 3
- Study locations
Study Summary
This study will be a standard 3+3 design with a lead in of TGR-1202 at dose of 600mg (dose level 1) or 800mg daily (dose level 2) for 6 weeks, i.e. 2 cycles, followed by pembrolizumab at 200mg every 3 weeks for 8 cycles along with TGR-1202 for patients with relapsed/refractory B-cell NHL or CLL. If the dose of 600mg daily of TGR-1202 (dose level 1) is tolerated in the first cohort the dose will be increased to 800mg qd which is the only and final dose escalation. If TGR-1202 is not tolerated at 600mg daily the dose will be decreased to 400mg daily. The lead in of TGR-1202 was chosen to ensure clinical benefit and to minimize the occurrence of early overlapping toxicity with pembrolizumab as most toxicities were observed early on in the treatment with idelalisib, a related PI3K-inhibitor, and rituximab.
Conditions Studied
Interventions
- DRUG Pembrolizumab
- DRUG TGR-1202
Study Locations (3)
Connecticut
- Yale University - New Haven
Illinois
- University of Chicago - Chicago
New York
- Memorial Sloan Kettering Cancer Center - New York
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 20 participants |
| Start Date | 2018-01-23 |
| Est. Completion | 2027-12 |
| Phase | Phase 1 |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT03283137
The ClinicalTrials.gov registry entry for NCT03283137 describes a study currently listed as active not recruiting, categorized as Phase 1. The registered enrollment target is 20 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 129-participant average among 24 other B-Cell Non-Hodgkin Lymphoma trials with a reported enrollment target (84% lower). The listed sponsor is University of Chicago, which has 796 total studies on file at ClinicalTrials.gov.
The record links to 2 conditions, with B-Cell Non-Hodgkin Lymphoma appearing as the primary indexed condition, and to 2 interventions - of which Pembrolizumab is the first listed.
NCT03283137 reports 3 study locations spanning 3 distinct geographic areas - top geographies include Connecticut, Illinois, New York.
Frequently Asked Questions
What is clinical trial NCT03283137 about?
NCT03283137 is a clinical study titled "Combination of Pembrolizumab With TGR-1202 in Patients With Relapsed/Refractory CLL and B-cell NHL". This study will be a standard 3+3 design with a lead in of TGR-1202 at dose of 600mg (dose level 1) or 800mg daily (dose level 2) for 6 weeks, i.e. 2 cycles, followed by pembrolizumab at 200mg every 3 weeks for 8 cycles along with TGR-1202 for patients with relapsed/refractory B-cell NHL or CLL. If ...
What is the current status of trial NCT03283137?
This trial is currently active not recruiting. It is a Phase 1 study. The enrollment target is 20 participants. The study started on 2018-01-23. Estimated completion is 2027-12.
What conditions does trial NCT03283137 study?
This clinical trial studies the following conditions: B-Cell Non-Hodgkin Lymphoma, CLL.
What interventions are being tested in trial NCT03283137?
The interventions under investigation include: Pembrolizumab (DRUG), TGR-1202 (DRUG).
Who is sponsoring clinical trial NCT03283137?
This trial is sponsored by University of Chicago, which has 796 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT03283137 being conducted?
This trial has 3 study locations across Connecticut, Illinois, New York. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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