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

Official Title

A Phase 1, Multicentre, Open-label Study of BMS-986403 in Subjects With Relapsed and/or Refractory Chronic Lymphocytic Leukemia (CLL) or Small Lymphocytic Lymphoma (SLL)

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).

Trial Description

Primary Outcome:

  • Number of participants with adverse events (AEs)
  • Number of participants with serious adverse events (SAEs)
  • Number of participants with clinical laboratory abnormalities
  • Number of participants with dose-limiting toxicity (DLT)
  • Maximum-tolerated dose (MTD) based on the incidence of DLTs that occur during the DLT evaluation period
  • Recommended Phase 2 Dose (RP2D) based on the incidence of DLTs that occur during the DLT evaluation period
Secondary Outcome:
  • Overall response rate (ORR)
  • Complete remission rate (CRR)
  • Duration of response (DOR)
  • Duration of complete remission (DOCR)
  • Time to response (TTR)
  • Time to CR (TTCR)
  • Progression free survival (PFS)
  • Overall survival (OS)
  • Pharmacokinetics by polymerase chain reaction (PCR): Maximum concentration (Cmax)
  • Pharmacokinetics by PCR: Time to peak (maximum) concentration (Tmax)
  • Pharmacokinetics by PCR: Area under the curve (AUC)

View this trial on ClinicalTrials.gov

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Resources

Canadian Cancer Society

These resources are provided in partnership with the Canadian Cancer Society