A Phase 2 Open-Label Study of the Efficacy and Safety of ABT-199 (GDC-0199) in Chronic Lymphocytic Leukemia (CLL) Subjects With Relapse or Refractory to B-Cell Receptor Signaling Pathway Inhibitor Therapy
NCT ID: NCT02141282
Last Updated: 2022-12-19
Study Results
Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.
View full resultsBasic Information
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COMPLETED
PHASE2
127 participants
INTERVENTIONAL
2014-09-10
2021-12-22
Brief Summary
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Detailed Description
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Conditions
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Keywords
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Study Design
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NON_RANDOMIZED
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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ABT-199 after ibrutinib therapy
Participants with ibrutinib-resistant or refractory chronic lymphocytic leukemia (CLL) received venetoclax tablets once daily (QD) until disease progression or study drug discontinuation; median time on treatment was 593 days. The starting dose was 20 mg daily, increasing over a period of 5 weeks up to the daily dose of 400 mg.
Venetoclax
Each dose of venetoclax was to be taken with approximately 240 mL of water within 30 minutes after the completion of breakfast or the participant's first meal of the day.
ABT-199 after idelalisib therapy
Participants with idelalisib-resistant or refractory chronic lymphocytic leukemia (CLL) received venetoclax tablets once daily (QD) until disease progression or study drug discontinuation; median time on treatment was 1023 days. The starting dose was 20 mg daily, increasing over a period of 5 weeks up to the daily dose of 400 mg.
Venetoclax
Each dose of venetoclax was to be taken with approximately 240 mL of water within 30 minutes after the completion of breakfast or the participant's first meal of the day.
ABT-199 after ibrutinib therapy: Expansion Cohort
Participants with ibrutinib-resistant or refractory chronic lymphocytic leukemia (CLL) received venetoclax tablets once daily (QD) until disease progression or study drug discontinuation; median time on treatment was 622 days. The starting dose was 20 mg daily, increasing over a period of 5 weeks up to the daily dose of 400 mg. Participants enrolled into the Expansion Cohort with bulky disease at study entry who were non-responders or those who showed signs of clinical progression after completing the ramp up to 400 mg either by clinical disease assessment or by CT/MRI scan between Week 6 to Week 12 may have been permitted to escalate venetoclax to a daily dose of 600 mg.
Venetoclax
Each dose of venetoclax was to be taken with approximately 240 mL of water within 30 minutes after the completion of breakfast or the participant's first meal of the day.
ABT-199 after idelalisib therapy: Expansion Cohort
Participants with idelalisib-resistant or refractory chronic lymphocytic leukemia (CLL) received venetoclax tablets once daily (QD) until disease progression or study drug discontinuation; median time on treatment was 1189 days. The starting dose was 20 mg daily, increasing over a period of 5 weeks up to the daily dose of 400 mg. Participants enrolled into the Expansion Cohort with bulky disease at study entry who were non-responders or those who showed signs of clinical progression after completing the ramp up to 400 mg either by clinical disease assessment or by CT/MRI scan between Week 6 to Week 12 may have been permitted to escalate venetoclax to a daily dose of 600 mg.
Venetoclax
Each dose of venetoclax was to be taken with approximately 240 mL of water within 30 minutes after the completion of breakfast or the participant's first meal of the day.
Interventions
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Venetoclax
Each dose of venetoclax was to be taken with approximately 240 mL of water within 30 minutes after the completion of breakfast or the participant's first meal of the day.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Participant has relapsed/refractory disease with an indication for treatment
* Participant has refractory disease or developed recurrence after therapy with a B-cell receptor pathway inhibitor (BCR PI)
* Participant must have an Eastern Cooperative Oncology Group performance score of ≤ 2
* Participant must have adequate bone marrow function at Screening
* Participant must have adequate coagulation profile, renal, and hepatic function, per laboratory reference range at Screening
Exclusion Criteria
* Participant has developed Richter's transformation confirmed by biopsy
* Participant has active and uncontrolled autoimmune cytopenia
* Participant has malabsorption syndrome or other condition that precludes enteral route of administration
* Participant is human immunodeficiency virus (HIV) positive or has chronic hepatitis B or hepatitis C virus requiring treatment
* Participant has known contraindication or allergy to both xanthine oxidase inhibitors and rasburicase
18 Years
99 Years
ALL
No
Sponsors
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Roche-Genentech
INDUSTRY
AbbVie
INDUSTRY
Responsible Party
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Principal Investigators
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ABBVIE INC.
Role: STUDY_DIRECTOR
AbbVie
Locations
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Moores Cancer Center at UC San Diego /ID# 128535
La Jolla, California, United States
University of California, Los Angeles /ID# 127262
Los Angeles, California, United States
Stanford University School of Med /ID# 126495
Stanford, California, United States
Georgetown University Hospital /ID# 127261
Washington D.C., District of Columbia, United States
Emory Midtown Infectious Disease Clinic /ID# 131249
Atlanta, Georgia, United States
Northwestern University Feinberg School of Medicine /ID# 126497
Chicago, Illinois, United States
Beth Israel Deaconess Medical Center /ID# 134509
Boston, Massachusetts, United States
Dana-Farber Cancer Institute /ID# 126496
Boston, Massachusetts, United States
Columbia Univ Medical Center /ID# 128536
New York, New York, United States
New York Presbyterian Hospital Weill Cornell Medical Center /ID# 129648
New York, New York, United States
Univ Rochester Med Ctr /ID# 130011
Rochester, New York, United States
The Ohio State University /ID# 127263
Columbus, Ohio, United States
University of Pennsylvania /ID# 126860
Philadelphia, Pennsylvania, United States
University of Texas MD Anderson Cancer Center /ID# 126498
Houston, Texas, United States
University of Utah /ID# 130813
Salt Lake City, Utah, United States
Countries
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References
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Roberts AW, Ma S, Kipps TJ, Coutre SE, Davids MS, Eichhorst B, Hallek M, Byrd JC, Humphrey K, Zhou L, Chyla B, Nielsen J, Potluri J, Kim SY, Verdugo M, Stilgenbauer S, Wierda WG, Seymour JF. Efficacy of venetoclax in relapsed chronic lymphocytic leukemia is influenced by disease and response variables. Blood. 2019 Jul 11;134(2):111-122. doi: 10.1182/blood.2018882555. Epub 2019 Apr 25.
Coutre S, Choi M, Furman RR, Eradat H, Heffner L, Jones JA, Chyla B, Zhou L, Agarwal S, Waskiewicz T, Verdugo M, Humerickhouse RA, Potluri J, Wierda WG, Davids MS. Venetoclax for patients with chronic lymphocytic leukemia who progressed during or after idelalisib therapy. Blood. 2018 Apr 12;131(15):1704-1711. doi: 10.1182/blood-2017-06-788133. Epub 2018 Jan 5.
Jones JA, Mato AR, Wierda WG, Davids MS, Choi M, Cheson BD, Furman RR, Lamanna N, Barr PM, Zhou L, Chyla B, Salem AH, Verdugo M, Humerickhouse RA, Potluri J, Coutre S, Woyach J, Byrd JC. Venetoclax for chronic lymphocytic leukaemia progressing after ibrutinib: an interim analysis of a multicentre, open-label, phase 2 trial. Lancet Oncol. 2018 Jan;19(1):65-75. doi: 10.1016/S1470-2045(17)30909-9. Epub 2017 Dec 12.
Provided Documents
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Document Type: Study Protocol
Document Type: Statistical Analysis Plan
Related Links
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clinical study report synopsis
Other Identifiers
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M14-032
Identifier Type: -
Identifier Source: org_study_id