A Study to Evaluate the Safety and Tolerability of BMS-986403 in Participants With Relapsed and/or Refractory Chronic Lymphocytic Leukemia or Small Lymphocytic Lymphoma
NCT ID: NCT05244070
Last Updated: 2023-07-18
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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TERMINATED
PHASE1
5 participants
INTERVENTIONAL
2022-09-14
2023-05-04
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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BMS-986403 + Fludarabine + Cyclophosphamide
BMS-986403
Specified dose on specified days
Fludarabine
Specified dose on specified days
Cyclophosphamide
Specified dose on specified days
Interventions
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BMS-986403
Specified dose on specified days
Fludarabine
Specified dose on specified days
Cyclophosphamide
Specified dose on specified days
Eligibility Criteria
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Inclusion Criteria
* Eastern Cooperative Oncology Group (ECOG) performance status of ≤ 1
* Either currently has central vascular access or is a candidate to receive central vascular access or peripheral vascular access for leukapheresis procedure
* Has recovery to Grade ≤ 1 or baseline of any non-hematologic toxicities due to previous therapy, except alopecia (any Grade acceptable) and peripheral neuropathy (Grade ≤ 2 acceptable)
Exclusion Criteria
* Systemic fungal, bacterial, viral, or other infection that is not controlled
* Active autoimmune disease requiring immunosuppressive therapy
* Progressive deep vein thrombosis or pulmonary embolism requiring treatment, but not yet on a stable anticoagulation regimen
18 Years
ALL
No
Sponsors
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Bristol-Myers Squibb
INDUSTRY
Responsible Party
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Principal Investigators
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Bristol-Myers Squibb
Role: STUDY_DIRECTOR
Bristol-Myers Squibb
Locations
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Local Institution - 0005
Birmingham, Alabama, United States
Local Institution - 0016
Duarte, California, United States
Local Institution - 0007
Boston, Massachusetts, United States
Local Institution - 0026
Hackensack, New Jersey, United States
Local Institution - 0009
Columbus, Ohio, United States
Local Institution - 0002
Seattle, Washington, United States
Local Institution - 0024
Barcelona, , Spain
Local Institution
Madrid, , Spain
Local Institution
Salamanca, , Spain
Countries
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Related Links
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BMS Clinical Trial Information
BMS Clinical Trial Patient Recruiting
Other Identifiers
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2021-003274-31
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
CA097-001
Identifier Type: -
Identifier Source: org_study_id
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