Safety and Efficacy of Entospletinib With Vincristine and Dexamethasone in Adults With Relapsed or Refractory Acute Lymphoid Leukemia (ALL)

Official Title

A Phase 1b, Open-Label, Dose Escalation and Expansion Study Evaluating the Safety and Efficacy of Entospletinib (GS-9973) With Vincristine and Dexamethasone in Adult Subjects With Relapsed or Refractory Acute Lymphoid Leukemia (ALL)

Summary:

This study will evaluate the safety, efficacy, tolerability, and pharmacokinetics of entospletinib (GS-9973) in combination with vincristine (VCR), and dexamethasone in adults with previously treated relapsed or refractory B-cell lineage acute lymphoid leukemia (ALL). This study consists of two parts: Dose Escalation and Dose Expansion. After 2 induction cycles during either parts of the study, participants may be put on maintenance for up to 36 cycles if they have obtained clinical benefit from the treatment.

Trial Description

Primary Outcome:

  • Occurrence of adverse events and laboratory abnormalities defined as dose limiting toxicities (DLTs)
Secondary Outcome:
  • Overall remission (CR or CRi) rate at end of induction
  • Complete remission (CR) rate at end of induction
  • Number and proportion of participants who receive post-treatment hematopoietic stem cell transplant (HSCT)
  • Number and proportion of participants who receive other post-treatment leukemia therapy
  • Partial response (PR) rate at end of induction
  • Overall response (CR, CRi, or PR) rate at end of induction

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