Duvelisib With Obinutuzumab in Patients With CLL/SLL Previously Treated With a BTKi (SYNCHRONY)

Official Title

A Phase 1b Study of Duvelisib Administered in Combination With Obinutuzumab in Patients With CLL/SLL Previously Treated With a Bruton's Tyrosine Kinase Inhibitor (BTKi) (SYNCHRONY)

Summary:

To evaluate the safety, pharmacokinetics, and pharmacodynamics of Duvelisib (IPI-145) in combination with obinutuzumab in patients with Chronic Lymphocytic Leukemia/Small Lymphocytic Lymphoma previously treated with a BTKi.

Trial Description

Primary Outcome:

  • Dose-limiting toxicities (DLTs)
  • Treatment-emergent adverse events (TEAEs)
Secondary Outcome:
  • Overall response rate (ORR)
  • Duration of response (DOR)
  • Progression-free survival (PFS)
  • Overall survival (OS)
  • BTK mutation status
  • Pharmacokinetic (PK) parameters of duvelisib and IPI-656 (major metabolite)
This is a Phase 1b, open-label, dose escalation, safety and tolerability study of Duvelisib (IPI-145) in combination with obinutuzumab in subjects with Chronic Lymphocytic Leukemia/Small Lymphocytic Lymphoma previously treated with a BTKi therapy.

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