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NCT01328626 · ClinicalTrials.gov registry record · Phase 1
A Phase 1 Study Evaluating the Safety and Pharmacokinetics of ABT-199 in Subjects With Relapsed or Refractory Chronic Lymphocytic Leukemia and Non-Hodgkin Lymphoma
A Phase 1 study of Chronic Lymphocytic Leukemia and Non-Hodgkin Lymphoma, sponsored by AbbVie.
- Completed
- Registry status
- Phase 1
- Development phase
- 222
- Enrollment target
- 10
- Study locations
NCT01328626: Completed Phase 1 study of Chronic Lymphocytic Leukemia and Non-Hodgkin Lymphoma, sponsored by AbbVie.
NCT01328626 is a Phase 1 study of Chronic Lymphocytic Leukemia and Non-Hodgkin Lymphoma that has completed, run by AbbVie. The registered enrollment target is 222 participants, above the 181-participant average among 187 other Chronic Lymphocytic Leukemia trials with a reported enrollment target (23% higher). The trial reports 10 study locations across 8 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01328626, a Phase 1 study of Chronic Lymphocytic Leukemia and Non-Hodgkin Lymphoma, has completed, sponsored by AbbVie.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 222 participants
- Enrollment target
- 10
- Study locations
Study Summary
This is a Phase 1, open-label, multicenter study evaluating the safety and PK profile of ABT-199 under a once daily dosing schedule. Two arms will be implemented for dose escalation: Arm A, CLL/SLL subjects and Arm B, NHL subjects. Arm A is designed to enroll approximately 116 subjects with relapsed or refractory CLL or SLL and Arm B is designed to enroll approximately 95 subjects with relapsed or refractory NHL. Fifty-six subjects were enrolled in Arm A and approximately 55 subjects will be enrolled in Arm B during the dose escalation portion of the study, with the objective of defining dose limiting toxicities (DLTs) and the MTD. Once the MTD is declared for the arm, approximately 60 additional CLL/SLL subjects in Arm A and approximately 20 additional DLBCL subjects and 20 additional follicular lymphoma subjects in Arm B will be enrolled in an expanded safety portion of the study at the recommended phase 2 dose (RPTD) and schedule.
Primary Outcome
Protocol-defined events, which can not be attributed by the investigator to a clearly identifiable cause such as tumor progression, underlying illness, concurrent illness, or concomitant medication, will be considered a DLT. Dose limiting toxicities of tumor lysis syndrome observed during the lead-in period will be attributed to the lead-in period.
Conditions Studied
Interventions
- DRUG ABT-199
Study Locations (10)
Washington
- Swedish Medical Center /ID# 135853 - Seattle
- Fred Hutchinson Cancer Research /ID# 52882 - Seattle
Victoria
- Peter MacCallum Cancer Ctr /ID# 48323 - Melbourne
- Royal Melbourne Hospital /ID# 48322 - Parkville
Arizona
- University of Arizona Cancer Center - North Campus /ID# 52902 - Tucson
California
- Ucsd /Id# 48325 - La Jolla
Massachusetts
- Dana-Farber Cancer Institute /ID# 48324 - Boston
New York
- Memorial Sloan Kettering Cancer Center /ID# 56810 - New York
Texas
- University of Texas MD Anderson Cancer Center /ID# 48326 - Houston
Wisconsin
- Univ of Wisconsin Hosp/Clinics /ID# 56811 - Madison
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 222 participants |
| Start Date | 2011-05-23 |
| Est. Completion | 2020-05-08 |
| Phase | Phase 1 |
What the finished NCT01328626 record still lists
NCT01328626 is an interventional study that assigns participants to a tested intervention. The registered 222 participants enrollment target is mid-sized for trials with a published cap, above the 181-participant average among 187 other Chronic Lymphocytic Leukemia trials with a reported enrollment target (23% higher).
The record links to 2 conditions, with Chronic Lymphocytic Leukemia appearing as the primary indexed condition, and to 1 intervention - of which ABT-199 is the first listed.
NCT01328626 lists 10 locations in 8 states (Washington, Victoria, Arizona).
Frequently Asked Questions
What is clinical trial NCT01328626 about?
NCT01328626 is a clinical study titled "A Phase 1 Study Evaluating the Safety and Pharmacokinetics of ABT-199 in Subjects With Relapsed or Refractory Chronic Lymphocytic Leukemia and Non-Hodgkin Lymphoma". This is a Phase 1, open-label, multicenter study evaluating the safety and PK profile of ABT-199 under a once daily dosing schedule. Two arms will be implemented for dose escalation: Arm A, CLL/SLL subjects and Arm B, NHL subjects. Arm A is designed to enroll approximately 116 subjects with relapsed...
What is the current status of trial NCT01328626?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 222 participants. The study started on 2011-05-23. Estimated completion is 2020-05-08.
What conditions does trial NCT01328626 study?
This clinical trial studies the following conditions: Chronic Lymphocytic Leukemia, Non-Hodgkin Lymphoma.
What interventions are being tested in trial NCT01328626?
The interventions under investigation include: ABT-199 (DRUG).
Who is sponsoring clinical trial NCT01328626?
This trial is sponsored by AbbVie, which has 526 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT01328626 being conducted?
This trial has 10 study locations across Arizona, California, Massachusetts, New York, Texas. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
Similar trials for Chronic Lymphocytic Leukemia
Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT01328626's enrollment target sits among peer trials
222 39th of 187 higher than 149 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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