A Study of Venetoclax in Combination With Bendamustine + Rituximab or Bendamustine + Obinutuzumab in Participants With Relapsed/Refractory or Previously Untreated Chronic Lymphocytic Leukemia (CLL)
NCT ID: NCT01671904
Last Updated: 2020-10-14
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE1
84 participants
INTERVENTIONAL
2014-01-13
2020-08-11
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NON_RANDOMIZED
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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1L CLL BR+V
Participants with first-line (1L)/previously untreated CLL were administered escalating doses of venetoclax (V) in combination with fixed dose bendamustine and rituximab (BR). Participants received six 28-day cycles of BR+V. Participants with 1L CLL received 6 months of single-agent venetoclax for a total of 1-year treatment duration. Single-agent venetoclax could be extended if there was detectable minimal residual disease (MRD) in the bone marrow and/or partial response (PR) after 1 year of treatment and upon the request of the treating physician.
Bendamustine
Participants will receive intravenous (IV) infusion of bendamustine (90 or 70 milligrams per square meter \[mg/m\^2\]) on Days 2-3 of Cycle 1 and Days 1-2 of Cycles 2-6.
Rituximab
Participants will receive IV infusion of rituximab (375 mg/m\^2) on Day 1 of Cycle 1 and 500 mg/m\^2 administered on Day 1 of Cycles 2-6.
Venetoclax
Participants will receive multiple doses of venetoclax orally once daily.
1L CLL BG+V
Participants with first-line (1L)/previously untreated CLL were administered escalating doses of venetoclax (V) in combination with fixed dose bendamustine and obinutuzumab (BG). Participants received six 28-day cycles of BG+V. Participants with 1L CLL received 6 months of single-agent venetoclax for a total of 1-year treatment duration. Single-agent venetoclax could be extended if there was detectable minimal residual disease (MRD) in the bone marrow and/or partial response (PR) after 1 year of treatment and upon the request of the treating physician.
Bendamustine
Participants will receive intravenous (IV) infusion of bendamustine (90 or 70 milligrams per square meter \[mg/m\^2\]) on Days 2-3 of Cycle 1 and Days 1-2 of Cycles 2-6.
Obinutuzumab
Participants will receive IV infusion of obinutuzumab (100 milligrams \[mg\]) on Day 1 of Cycle 1; 900 mg administered on Day 2 of Cycle 1; and 1000 mg administered on Days 8 and 15 of Cycle 1 and on Day 1 of Cycles 2-6.
Venetoclax
Participants will receive multiple doses of venetoclax orally once daily.
R/R CLL BR+V
Participants with relapsed/refractory (R/R) CLL were administered escalating doses of venetoclax (V) in combination with fixed dose bendamustine and rituximab (BR). Participants received six 28-day cycles of BR+V. Participants with R/R CLL continued single-agent venetoclax until disease progression, death, or unacceptable toxicity.
Bendamustine
Participants will receive intravenous (IV) infusion of bendamustine (90 or 70 milligrams per square meter \[mg/m\^2\]) on Days 2-3 of Cycle 1 and Days 1-2 of Cycles 2-6.
Rituximab
Participants will receive IV infusion of rituximab (375 mg/m\^2) on Day 1 of Cycle 1 and 500 mg/m\^2 administered on Day 1 of Cycles 2-6.
Venetoclax
Participants will receive multiple doses of venetoclax orally once daily.
Interventions
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Bendamustine
Participants will receive intravenous (IV) infusion of bendamustine (90 or 70 milligrams per square meter \[mg/m\^2\]) on Days 2-3 of Cycle 1 and Days 1-2 of Cycles 2-6.
Obinutuzumab
Participants will receive IV infusion of obinutuzumab (100 milligrams \[mg\]) on Day 1 of Cycle 1; 900 mg administered on Day 2 of Cycle 1; and 1000 mg administered on Days 8 and 15 of Cycle 1 and on Day 1 of Cycles 2-6.
Rituximab
Participants will receive IV infusion of rituximab (375 mg/m\^2) on Day 1 of Cycle 1 and 500 mg/m\^2 administered on Day 1 of Cycles 2-6.
Venetoclax
Participants will receive multiple doses of venetoclax orally once daily.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Eastern Cooperative Oncology Group (ECOG) performance score of less than equal to (\</=) 1
* Adequate bone marrow function
* Adequate coagulation, renal and hepatic function
* Hematological values within the limits independent of growth factor support or transfusion unless cytopenia is caused by the underlying disease, i.e., no evidence of additional bone marrow dysfunction (e.g., myelodysplastic syndrome, hypoplastic bone marrow)
Exclusion Criteria
* Known human immunodeficiency virus (HIV) positivity
* Uncontrolled autoimmune hemolytic anemia or thrombocytopenia
* Positive test results for chronic hepatitis B infection and hepatitis C virus (HCV)
* Received any anti-cancer therapy including chemotherapy or radiotherapy, steroid therapy for anti-neoplastic intent, and investigational therapy, including targeted small molecule agents within 28 days prior to the first dose of study drug or has not recovered to less than Grade 2 clinically significant adverse effect(s)/toxicity(s) of the previous therapy
* Significant history of renal, neurologic, psychiatric, endocrinologic, metabolic, immunologic, cardiovascular, or hepatic disease
18 Years
ALL
No
Sponsors
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AbbVie (prior sponsor, Abbott)
INDUSTRY
Genentech, Inc.
INDUSTRY
Responsible Party
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Principal Investigators
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Clinical Trials
Role: STUDY_DIRECTOR
Genentech, Inc.
Locations
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University of California San Diego Medical Center
La Jolla, California, United States
Ingalls Hospital; Cancer Clinical Trials
Harvey, Illinois, United States
Karmanos Cancer Institute
Detroit, Michigan, United States
North Star Lodge
Yakima, Washington, United States
Hopital Claude Huriez
Lille, , France
Hopital Saint Eloi
Montpellier, , France
Centre Hospitalier Lyon Sud
Pierre-Bénite, , France
Centre Henri Becquerel
Rouen, , France
Universitatsklinik Koln
Cologne, , Germany
Apotheke des Universitätsklinikums Freiburg
Freiburg im Breisgau, , Germany
Klinikum Schwabing
München, , Germany
Universtitätsklinikum Ulm; Klinik für Innere Medizin III
Ulm, , Germany
Countries
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Other Identifiers
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2012-002351-42
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
GO28440
Identifier Type: -
Identifier Source: org_study_id
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