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Last Updated: October 24, 2020

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CLINICAL TRIALS PROFILE FOR VENETOCLAX

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All Clinical Trials for Venetoclax

Trial ID Title Status Sponsor Phase Start Date Summary
NCT01671904 A Study of Venetoclax in Combination With Bendamustine + Rituximab or Bendamustine + Obinutuzumab in Participants With Relapsed/Refractory or Previously Untreated Chronic Lymphocytic Leukemia (CLL) Recruiting AbbVie (prior sponsor, Abbott) Phase 1 2014-01-01 This multi-center, open-label, dose-finding study will evaluate the safety and pharmacokinetics of venetoclax (GDC-0199, ABT-199) administered in combination with bendamustine and rituximab (BR) (MabThera/Rituxan) or bendamustine and obinutuzumab (BG) to participants with relapsed/refractory or previously untreated CLL. The study will explore two schedules for drug administration, Schedule A (venetoclax introduced before other agents) and Schedule B (introduced after other agents). In addition, the study will explore two venetoclax combination regimens: venetoclax+BR and venetoclax + BG (the latter is optional). The study is comprised of two stages for each participant population: a dose-finding stage and a safety-expansion stage. The dose-finding stage will explore multiple doses of venetoclax to be used in combination with fixed doses of BR or BG.
NCT01671904 A Study of Venetoclax in Combination With Bendamustine + Rituximab or Bendamustine + Obinutuzumab in Participants With Relapsed/Refractory or Previously Untreated Chronic Lymphocytic Leukemia (CLL) Recruiting Genentech, Inc. Phase 1 2014-01-01 This multi-center, open-label, dose-finding study will evaluate the safety and pharmacokinetics of venetoclax (GDC-0199, ABT-199) administered in combination with bendamustine and rituximab (BR) (MabThera/Rituxan) or bendamustine and obinutuzumab (BG) to participants with relapsed/refractory or previously untreated CLL. The study will explore two schedules for drug administration, Schedule A (venetoclax introduced before other agents) and Schedule B (introduced after other agents). In addition, the study will explore two venetoclax combination regimens: venetoclax+BR and venetoclax + BG (the latter is optional). The study is comprised of two stages for each participant population: a dose-finding stage and a safety-expansion stage. The dose-finding stage will explore multiple doses of venetoclax to be used in combination with fixed doses of BR or BG.
NCT01682616 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 Active, not recruiting Genentech, Inc. Phase 1 2012-08-01 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, subjects may re-initiate ABT-199.
NCT01682616 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 Active, not recruiting AbbVie (prior sponsor, Abbott) Phase 1 2012-08-01 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, subjects may re-initiate ABT-199.
>Trial ID >Title >Status >Phase >Start Date >Summary

Clinical Trial Conditions for Venetoclax

Condition Name

Condition Name for Venetoclax
Intervention Trials
Acute Myeloid Leukemia 33
Chronic Lymphocytic Leukemia 28
Acute Myeloid Leukemia (AML) 13
Small Lymphocytic Lymphoma 9
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Condition MeSH

Condition MeSH for Venetoclax
Intervention Trials
Leukemia 109
Leukemia, Lymphoid 60
Leukemia, Myeloid, Acute 59
Leukemia, Lymphocytic, Chronic, B-Cell 54
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Clinical Trial Locations for Venetoclax

Trials by Country

Trials by Country for Venetoclax
Location Trials
United States 382
Japan 41
Australia 33
Germany 23
Italy 22
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Trials by US State

Trials by US State for Venetoclax
Location Trials
Texas 47
California 26
New York 24
Massachusetts 24
Ohio 23
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Clinical Trial Progress for Venetoclax

Clinical Trial Phase

Clinical Trial Phase for Venetoclax
Clinical Trial Phase Trials
Phase 3 23
Phase 2/Phase 3 2
Phase 2 72
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Clinical Trial Status

Clinical Trial Status for Venetoclax
Clinical Trial Phase Trials
Not yet recruiting 138
Recruiting 58
Active, not recruiting 4
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Clinical Trial Sponsors for Venetoclax

Sponsor Name

Sponsor Name for Venetoclax
Sponsor Trials
AbbVie 61
National Cancer Institute (NCI) 42
M.D. Anderson Cancer Center 28
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Sponsor Type

Sponsor Type for Venetoclax
Sponsor Trials
Industry 161
Other 136
NIH 43
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