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NCT01682616 · ClinicalTrials.gov registry record · Phase 1
A Phase 1b Study Evaluating the Safety and Tolerability of ABT-199 in Combination With Rituximab in Subjects With Relapsed Chronic Lymphocytic Leukemia and Small Lymphocytic Lymphoma
A Phase 1 study of Chronic Lymphocytic Leukemia and Small Lymphocytic Lymphoma, sponsored by AbbVie.
- Completed
- Registry status
- Phase 1
- Development phase
- 49
- Enrollment target
- 6
- Study locations
NCT01682616: Completed Phase 1 study of Chronic Lymphocytic Leukemia and Small Lymphocytic Lymphoma, sponsored by AbbVie.
NCT01682616 is a Phase 1 study of Chronic Lymphocytic Leukemia and Small Lymphocytic Lymphoma that has completed, run by AbbVie. The registered enrollment target is 49 participants, below the 182-participant average among 187 other Chronic Lymphocytic Leukemia trials with a reported enrollment target (73% lower). The trial reports 6 study locations across 5 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01682616, a Phase 1 study of Chronic Lymphocytic Leukemia and Small Lymphocytic Lymphoma, has completed, sponsored by AbbVie.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 49 participants
- Enrollment target
- 6
- Study locations
Study Summary
This is a Phase 1b, open-label, multicenter study evaluating the safety and tolerability of ABT-199 in combination with rituximab in up to 50 subjects with Relapsed Chronic Lymphocytic Leukemia and Small Lymphocytic Lymphoma. The primary objectives of this study are to assess the safety profile, to determine the maximum tolerated dose and establish the Recommended Phase Two Dose of ABT-199 when administered in combination with rituximab. The dose escalation portion of the study will include approximately 30 subjects. Once the recommended phase two dose and schedule have been determined, up to 20 additional subjects will be enrolled in an expanded safety portion of the study. Subjects who meet criteria for CR, CRi, or MRD-negative PR during the study may discontinue ABT 199. If disease progression occurs, as defined by iwCLL NCI/WG criteria for tumor response, or MRD progression, subjects may re-initiate ABT-199.
Primary Outcome
Protocol-defined events, which are attributed as having a reasonable possibility of being related to the administration of ABT-199 and/or rituximab, or can not be attributed by the investigator to a clearly identifiable cause such as tumor progression, concurrent illness, underlying disease or concomitant medication, will be considered a dose limiting toxicity.
Conditions Studied
Interventions
- DRUG Rituximab
- DRUG ABT-199
Study Locations (6)
Victoria
- Peter MacCallum Cancer Ctr /ID# 70394 - Melbourne
- The Royal Melbourne Hospital /ID# 70393 - Parkville
California
- Moores Cancer Center at UC San Diego /ID# 70398 - La Jolla
Illinois
- Northwestern University Feinberg School of Medicine /ID# 71593 - Chicago
New York
- North Shore University Hospital /ID# 71813 - New Hyde Park
North Carolina
- Duke Cancer Center /ID# 71393 - Durham
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 49 participants |
| Start Date | 2012-07-25 |
| Est. Completion | 2022-06-23 |
| Phase | Phase 1 |
What the finished NCT01682616 record still lists
NCT01682616 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 49 participants, a relatively small participant target, below the 182-participant average among 187 other Chronic Lymphocytic Leukemia trials with a reported enrollment target (73% lower).
The record links to 2 conditions, with Chronic Lymphocytic Leukemia appearing as the primary indexed condition, and to 2 interventions - of which Rituximab is the first listed.
NCT01682616 lists 6 locations in 5 states (Victoria, California, Illinois).
Frequently Asked Questions
What is clinical trial NCT01682616 about?
NCT01682616 is a clinical study titled "A Phase 1b Study Evaluating the Safety and Tolerability of ABT-199 in Combination With Rituximab in Subjects With Relapsed Chronic Lymphocytic Leukemia and Small Lymphocytic Lymphoma". This is a Phase 1b, open-label, multicenter study evaluating the safety and tolerability of ABT-199 in combination with rituximab in up to 50 subjects with Relapsed Chronic Lymphocytic Leukemia and Small Lymphocytic Lymphoma. The primary objectives of this study are to assess the safety profile, to ...
What is the current status of trial NCT01682616?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 49 participants. The study started on 2012-07-25. Estimated completion is 2022-06-23.
What conditions does trial NCT01682616 study?
This clinical trial studies the following conditions: Chronic Lymphocytic Leukemia, Small Lymphocytic Lymphoma.
What interventions are being tested in trial NCT01682616?
The interventions under investigation include: Rituximab (DRUG), ABT-199 (DRUG).
Who is sponsoring clinical trial NCT01682616?
This trial is sponsored by AbbVie, which has 526 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT01682616 being conducted?
This trial has 6 study locations across California, Illinois, New York, North Carolina, Victoria. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
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Where NCT01682616's enrollment target sits among peer trials
49 106th of 187 higher than 80 of 187 other Chronic Lymphocytic Leukemia trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Chronic Lymphocytic Leukemia 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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