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
Opdateret:
6 juni, 2023
|
ClinicalTrials.gov
Fase
Køn
Aldersinterval
Active, Not Recruiting
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
Hvis du vil rapportere en bivirkning, kan du indberette direkte til Lægemiddelstyrelsen via hjemmesiden www.meldenbivirkning.dk
Vi anbefaler at du også kontakter BMS for at rapportere bivirkninger.
Bivirkninger og andre rapporterbare begivenheder er defineret her
Rapporter bivirkninger eller klager over produktkvalitet: Medicinsk information
466-DK-2200001