Rituximab Plus Venetoclax in Combination With Zandelisib in Subjects With CLL
NCT ID: NCT05209308
Last Updated: 2023-03-16
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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WITHDRAWN
PHASE2
INTERVENTIONAL
2022-11-22
2023-03-15
Brief Summary
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Detailed Description
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VEN and R will be administered per standard of care.
Subjects must have histologically confirmed relapsed/refractory CLL and received ≥1 lines of prior therapy
A total 42 subjects will be enrolled and treated with zandelisib in combination with VEN + R.
Conditions
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Study Design
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NON_RANDOMIZED
SEQUENTIAL
A safety run-in Cohort A followed by Cohort B.
Both cohorts will follow the same dosing schedule and subjects will receive Zandelisib, however in Cohort A, VEN will be administered at a different dose then Cohort B.
TREATMENT
NONE
Study Groups
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Cohort A
Ven "low dose" + Rituximab + Zandelisib
Zandelisib
Zandelisib taken orally for 7 days of each 28 day cycle
Rituximab
Rituximab IV for 6 cycles
Venetoclax
Orally - Ramp up weeks 1-5
Cohort B
Ven "standard dose" + Rituximab + Zandelisib
Zandelisib
Zandelisib taken orally for 7 days of each 28 day cycle
Rituximab
Rituximab IV for 6 cycles
Venetoclax
Orally - Ramp up weeks 1-5
Interventions
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Zandelisib
Zandelisib taken orally for 7 days of each 28 day cycle
Rituximab
Rituximab IV for 6 cycles
Venetoclax
Orally - Ramp up weeks 1-5
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Histologically confirmed relapsed/refractory CLL who received ≥1 lines of prior therapy
* At least one bi-dimensionally measurable nodal lesion \>1.5 cm
* Adequate renal, hepatic function
* Adequate hematologic parameters at screening
Exclusion Criteria
* Relapsed within 2 years of discontinuation of prior PI3K inhibitor (PI3Ki) therapy or disease progression on PI3Ki therapy
* History or currently active HBV, HCV; any uncontrolled active infection, HIV infection; HIV-related lymphoma
* History of Richter's transformation or prolymphocytic leukemia
* Known allergies to both xanthine oxidase inhibitors and rasburicase, or any excipients of the drug products
* Currently active, clinically significant cardiovascular disease, such as uncontrolled arrhythmia or Class 3 or 4 congestive heart failure
* Pregnant women
18 Years
ALL
No
Sponsors
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Kyowa Kirin, Inc.
INDUSTRY
MEI Pharma, Inc.
INDUSTRY
Responsible Party
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Locations
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Dana Farber Cancer Institute
Boston, Massachusetts, United States
Stony Brook University
Stony Brook, New York, United States
OU Health Stephenson Cancer Center
Oklahoma City, Oklahoma, United States
Medical Oncology Associates, PS (dba Summit Cancer Centers)
Spokane, Washington, United States
Countries
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Other Identifiers
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ME-401-008
Identifier Type: -
Identifier Source: org_study_id
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