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NCT01732861 · ClinicalTrials.gov registry record · Phase 1
Safety Study of CC-292 and Lenalidomide in Subjects With Chronic Lymphocytic Leukemia/ Small Lymphocytic Lymphoma
A Phase 1 study of Leukemia, Lymphocytic, Chronic, B-Cell, sponsored by Celgene.
- Completed
- Registry status
- Phase 1
- Development phase
- 20
- Enrollment target
- 11
- Study locations
NCT01732861: Completed Phase 1 study of Leukemia, Lymphocytic, Chronic, B-Cell, sponsored by Celgene.
NCT01732861 is a Phase 1 study of Leukemia, Lymphocytic, Chronic, B-Cell that has completed, run by Celgene. The registered enrollment target is 20 participants, below the 489-participant average among 11 other Leukemia, Lymphocytic, Chronic, B-Cell trials with a reported enrollment target (96% lower). The trial reports 11 study locations across 7 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01732861, a Phase 1 study of Leukemia, Lymphocytic, Chronic, B-Cell, has completed, sponsored by Celgene.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 20 participants
- Enrollment target
- 11
- Study locations
Study Summary
This is a dose finding study using a 3 + 3 dose escalation and expansion design to determine a Not Tolerated Dose (NTD), Optimal Biological Effect Dose (OBE) and / or Maximum Tolerated Dose (MTD). These data will be used to establish a Recommended Phase 2 Dose (RP2D) for the combination of CC-292 and lenalidomide in subjects with Chronic Lymphocytic Leukemia (CLL).
Primary Outcome
Number of participants with adverse events
Conditions Studied
Interventions
- DRUG Lenalidomide
- DRUG CC-292
Study Locations (11)
Other
- Universitatsklinik fur Innere Medizin - Innsbruck
- AKh Linz - Linz
- Universitatsklinik der PMU - Salzburg
- Allgemeines Krankenhaus Wien - Vienna
- Medizinische Abteilung-Zentrum fur Onkologie und Hamatologie - Vienna
Alabama
- Clearview Cancer Institute Oncology Specialties, P.C - Huntsville
Indiana
- Horizon Oncology Center - Lafayette
New Jersey
- Hackensack University Medical Center - Hackensack
New York
- Mount Sinai School of Medicine - New York
Tennessee
- The West Clinic - Memphis
Texas
- MD Anderson Cancer Center - Houston
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 20 participants |
| Start Date | 2012-12-28 |
| Est. Completion | 2019-01-23 |
| Phase | Phase 1 |
What the finished NCT01732861 record still lists
NCT01732861 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 20 participants, a relatively small participant target, below the 489-participant average among 11 other Leukemia, Lymphocytic, Chronic, B-Cell trials with a reported enrollment target (96% lower).
The record links to 1 condition, with Leukemia, Lymphocytic, Chronic, B-Cell appearing as the primary indexed condition, and to 2 interventions - of which Lenalidomide is the first listed.
NCT01732861 lists 11 locations in 7 states (Other, Alabama, Indiana).
Frequently Asked Questions
What is clinical trial NCT01732861 about?
NCT01732861 is a clinical study titled "Safety Study of CC-292 and Lenalidomide in Subjects With Chronic Lymphocytic Leukemia/ Small Lymphocytic Lymphoma". This is a dose finding study using a 3 + 3 dose escalation and expansion design to determine a Not Tolerated Dose (NTD), Optimal Biological Effect Dose (OBE) and / or Maximum Tolerated Dose (MTD). These data will be used to establish a Recommended Phase 2 Dose (RP2D) for the combination of CC-292 an...
What is the current status of trial NCT01732861?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 20 participants. The study started on 2012-12-28. Estimated completion is 2019-01-23.
What conditions does trial NCT01732861 study?
This clinical trial studies the following conditions: Leukemia, Lymphocytic, Chronic, B-Cell.
What interventions are being tested in trial NCT01732861?
The interventions under investigation include: Lenalidomide (DRUG), CC-292 (DRUG).
Who is sponsoring clinical trial NCT01732861?
This trial is sponsored by Celgene, which has 308 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT01732861 being conducted?
This trial has 11 study locations across Alabama, Indiana, New Jersey, New York, Tennessee. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
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Where NCT01732861's enrollment target sits among peer trials
20 12th of 11 the lowest of 11 other Leukemia, Lymphocytic, Chronic, B-Cell trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Leukemia, Lymphocytic, Chronic, B-Cell 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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