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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 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.
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.
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 |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT01328626
The ClinicalTrials.gov registry entry for NCT01328626 describes a study currently listed as completed, categorized as Phase 1. The registered enrollment target is 222 participants, a figure that helps gauge the scale of data the investigators plan to collect, above the 181-participant average among 187 other Chronic Lymphocytic Leukemia trials with a reported enrollment target (23% higher). The listed sponsor is AbbVie, which has 526 total studies on file at ClinicalTrials.gov.
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 reports 10 study locations spanning 8 distinct geographic areas - top geographies include 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.
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