Leukemia, Lymphocytic, Chronic, B-Cell, Lymphoma
Conditions
Keywords
BMS-986403, Relapsed and/or Refractory, Small Lymphocytic Lymphoma (CLL), Chronic Lymphocytic Leukemia (SLL)
Brief summary
The purpose of this study is to evaluate the safety and preliminary efficacy of BMS-986403 in participants with relapsed and/or refractory chronic lymphocytic leukemia (R/R CLL) or small lymphocytic lymphoma (SLL).
Interventions
DRUGBMS-986403
Specified dose on specified days
DRUGFludarabine
Specified dose on specified days
DRUGCyclophosphamide
Specified dose on specified days
Sponsors
Bristol-Myers Squibb
Study design
Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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/
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Number of participants with adverse events (AEs) | Up to 2 years after BMS-986403 infusion |
| Number of participants with serious adverse events (SAEs) | Up to 2 years after BMS-986403 infusion |
| Number of participants with clinical laboratory abnormalities | Up to 2 years after BMS-986403 infusion |
| Number of participants with dose-limiting toxicity (DLT) | Up to 2 years after BMS-986403 infusion |
| Maximum-tolerated dose (MTD) based on the incidence of DLTs that occur during the DLT evaluation period | Up to 2 years after BMS-986403 infusion |
| Recommended Phase 2 Dose (RP2D) based on the incidence of DLTs that occur during the DLT evaluation period | Up to 2 years after BMS-986403 infusion |
Secondary
| Measure | Time frame |
|---|---|
| Progression free survival (PFS) | Up to 2 years after BMS-986403 infusion |
| Overall survival (OS) | Up to 2 years after BMS-986403 infusion |
| Overall response rate (ORR) | Up to 2 years after BMS-986403 infusion |
| Pharmacokinetics by PCR: Time to peak (maximum) concentration (Tmax) | Up to 2 years after BMS-986403 infusion |
| Pharmacokinetics by PCR: Area under the curve (AUC) | Up to 2 years after BMS-986403 infusion |
| Pharmacokinetics by polymerase chain reaction (PCR): Maximum concentration (Cmax) | Up to 2 years after BMS-986403 infusion |
| Complete remission rate (CRR) | Up to 2 years after BMS-986403 infusion |
| Duration of response (DOR) | Up to 2 years after BMS-986403 infusion |
| Duration of complete remission (DOCR) | Up to 2 years after BMS-986403 infusion |
| Time to response (TTR) | Up to 2 years after BMS-986403 infusion |
| Time to CR (TTCR) | Up to 2 years after BMS-986403 infusion |
Countries
Spain, United States
Outcome results
None listed