Study of Carfilzomib in Combination With Induction Chemotherapy in Children With Relapsed or Refractory Acute Lymphoblastic Leukemia

Official Title

Phase 1b Study of Carfilzomib in Combination With Induction Chemotherapy in Children With Relapsed or Refractory Acute Lymphoblastic Leukemia

Summary:

The purpose of the study is to determine the maximum tolerated dose and assess the safety, tolerability and activity of carfilzomib, alone and in combination with induction chemotherapy, in children with relapsed or refractory acute lymphoblastic leukemia (ALL).

Trial Description

Primary Outcome:

  • Adverse Events (AEs) and Serious Adverse Events (SAEs)
  • Key Laboratory Analytes
  • Vital Signs
  • Physical Findings
  • Time to Toxicity
  • Maximum Tolerated Dose (MTD)
Secondary Outcome:
  • Maximum plasma concentration (Cmax)
  • Total Plasma Exposure - Area Under the Curve (AUC)
  • Time to Peak Concentration (Tmax)
  • Total Plasma Clearance
  • Plasma Terminal Half-life
  • Minimal Residual Disease (MRD) Status

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