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Active, Not Recruiting

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 - CA097-001

Uppdaterad: 6 juni, 2023   |   ClinicalTrials.gov

Utskriftsvänlig sammanfattning

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Information om prövningen

  • Phase 1

    Fas

  • Kön

  • 18+

    Åldersintervall

  • Active, Not Recruiting

Behandlingsalternativ

Studiegrupper
TILLDELAD BEHANDLING
Experimental: BMS-986403 + Fludarabine + Cyclophosphamide
Drug: BMS-986403 Drug: Fludarabine Drug: Cyclophosphamide

Viktiga kriterier för deltagandet

Inclusion Criteria: - Participants with chronic lymphocytic leukemia (CLL) or small lymphocytic lymphoma (SLL) and high-risk features must have failed at least 2 lines of prior therapy and participants with CLL or SLL and standard risk features must have failed at least 3 lines of prior therapy - 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: - Any condition, including active or uncontrolled infection, or the presence of laboratory abnormalities, that places the subject at unacceptable risk if they were to participate in the study - 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 Other protocol-defined inclusion/exclusion criteria apply

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