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Protocol # 22-262

Status

Recruiting

Description

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).

Condition

  • Leukemia, Lymphocytic, Chronic, B-Cell
  • Lymphoma

Interventions

  • BMS-986403
  • Fludarabine
  • Cyclophosphamide

Phase

Phase 1

Study Type

Interventional

Further Study Details

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)

Enrollment

65

Study Start Date

September 14, 2022

Eligibility

  • Gender:     All
  • Minimum age:     18 Years
  • Maximum age:     N/A
  • Healthy volunteers:     No

Sponsors

Bristol-Myers Squibb

Source

Bristol-Myers Squibb

Official title

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

Clinicaltrials.gov Identifier

NCT05244070

     

Source: Clinicaltrials.gov. Through our founding membership in the Dana-Farber/Harvard Cancer Center, an NCI-designated Comprehensive Cancer Center, these clinical trials are conducted at the Massachusetts General Hospital Cancer Center and may be available at other partner institutions.