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NCT02268851 · ClinicalTrials.gov registry record · Phase 1
A Phase I/Ib Safety and Efficacy Study of the PI3K-delta Inhibitor TGR-1202 and Ibrutinib in Patients With CLL or MCL
A Phase 1 study of Mantle Cell Lymphoma and Chronic Lymphocytic Leukemia/Small Lymphocytic Lymphoma, sponsored by Dana-Farber Cancer Institute.
- Completed
- Registry status
- Phase 1
- Development phase
- 45
- Enrollment target
- 5
- Study locations
NCT02268851: Completed Phase 1 study of Mantle Cell Lymphoma and Chronic Lymphocytic Leukemia/Small Lymphocytic Lymphoma, sponsored by Dana-Farber Cancer Institute.
NCT02268851 is a Phase 1 study of Mantle Cell Lymphoma and Chronic Lymphocytic Leukemia/Small Lymphocytic Lymphoma that has completed, run by Dana-Farber Cancer Institute. The registered enrollment target is 45 participants, below the 104-participant average among 102 other Mantle Cell Lymphoma trials with a reported enrollment target (57% lower). The trial reports 5 study locations across 4 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT02268851, a Phase 1 study of Mantle Cell Lymphoma and Chronic Lymphocytic Leukemia/Small Lymphocytic Lymphoma, has completed, sponsored by Dana-Farber Cancer Institute.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 45 participants
- Enrollment target
- 5
- Study locations
Study Summary
This research study will be evaluating the safety and efficacy of a study drug called TGR-1202 in combination with a known drug ibrutinib, also known as Imbruvica, as a possible treatment for Chronic Lymphocytic Leukemia/Small Lymphocytic Lymphoma (CLL/SLL) or Mantle Cell Lymphoma (MCL) that has come back or that has not responded to standard treatment.
Primary Outcome
To assess the safety of TGR1202 in combination with ibrutinib relapsed or refractory CLL or MCL. DLT is based on the Common Terminology Criteria for Adverse Events (CTCAE) Version 4.0. DLT refers to toxicities experienced at any time during the study treatment, defined as Grade 4 anemia; Grade 4 neutropenia lasting \>7 days (while receiving growth factor support); Grade 4 thrombocytopenia lasting \> 7 days; Grade ≥3 febrile neutropenia; and Grade ≥3 thrombocytopenia with Grade \>2 hemorrhage;Gra
Conditions Studied
Interventions
- DRUG Ibrutinib
- DRUG TGR-1202
Study Locations (5)
Massachusetts
- Dana Farber Cancer Institute - Boston
- Beth Israel Deaconness Medical Center - Boston
California
- Pacific Cancer Care - Monterey
Connecticut
- St. Francis Hospital and Cancer Center - Hartford
Maine
- Eastern Maine Medical Center/ Northern Light Cancer Care - Brewer
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 45 participants |
| Start Date | 2014-11 |
| Est. Completion | 2022-10 |
| Phase | Phase 1 |
What the finished NCT02268851 record still lists
NCT02268851 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 45 participants, a relatively small participant target, below the 104-participant average among 102 other Mantle Cell Lymphoma trials with a reported enrollment target (57% lower).
The record links to 2 conditions, with Mantle Cell Lymphoma appearing as the primary indexed condition, and to 2 interventions - of which Ibrutinib is the first listed.
NCT02268851 lists 5 locations in 4 states (Massachusetts, California, Connecticut).
Frequently Asked Questions
What is clinical trial NCT02268851 about?
NCT02268851 is a clinical study titled "A Phase I/Ib Safety and Efficacy Study of the PI3K-delta Inhibitor TGR-1202 and Ibrutinib in Patients With CLL or MCL". This research study will be evaluating the safety and efficacy of a study drug called TGR-1202 in combination with a known drug ibrutinib, also known as Imbruvica, as a possible treatment for Chronic Lymphocytic Leukemia/Small Lymphocytic Lymphoma (CLL/SLL) or Mantle Cell Lymphoma (MCL) that has com...
What is the current status of trial NCT02268851?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 45 participants. The study started on 2014-11. Estimated completion is 2022-10.
What conditions does trial NCT02268851 study?
This clinical trial studies the following conditions: Mantle Cell Lymphoma, Chronic Lymphocytic Leukemia/Small Lymphocytic Lymphoma.
What interventions are being tested in trial NCT02268851?
The interventions under investigation include: Ibrutinib (DRUG), TGR-1202 (DRUG).
Who is sponsoring clinical trial NCT02268851?
This trial is sponsored by Dana-Farber Cancer Institute, which has 781 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT02268851 being conducted?
This trial has 5 study locations across California, Connecticut, Maine, Massachusetts. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
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Where NCT02268851's enrollment target sits among peer trials
45 48th of 102 higher than 52 of 102 other Mantle Cell Lymphoma trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Mantle Cell Lymphoma trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
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