Summary

Eligibility
for people ages 18 years and up (full criteria)
Location
at UCLA
Dates
study started
estimated completion

Description

Summary

Phase 2 clinical trial to evaluate the safety and efficacy of duvelisib as a monotherapy in subjects with iNHL (Follicular Lymphoma, Marginal Zone Lymphoma, or Small Lymphocytic Lymphoma) that is refractory to rituximab and to either chemotherapy or RIT.

Details

This is an open-label, single arm safety and efficacy study of duvelisib administered orally to subjects who have been diagnosed with iNHL (Follicular Lymphoma, Marginal Zone Lymphoma, or Small Lymphocytic Lymphoma) whose disease is refractory to rituximab and to either chemotherapy or RIT.

Approximately 120 subjects will receive 25 mg duvelisib BID over the course of 28-day treatment cycles for up to 13 cycles.

After completing 13 treatment cycles of duvelisib, subjects may continue to receive additional cycles of duvelisib until disease progression or unacceptable toxicity. However, to receive additional cycles of duvelisib beyond 13 cycles, subjects must have evidence of response (CR or PR) according to the IWG criteria1 by the end of Cycle 13.

Keywords

Indolent Non-Hodgkin Lymphoma PI3K Inhibitor Lymphoma Lymphoma, Non-Hodgkin Duvelisib

Eligibility

You can join if…

Open to people ages 18 years and up

  • Subjects who have been diagnosed with indolent NHL that has progressed.
  • Subjects must have exhibited lack of CR or PR or progression within 6 months after the last dose of a chemotherapy induction regimen or RIT.
  • Subjects must have rituximab-refractory disease, defined as lack of CR or PR or PD within 6 months of last dose.
  • Measurable disease with a lymph node or tumor mass ≥1.5 cm in at least one dimension by CT, PET/CT or MRI.
  • Adequate renal and hepatic function.

You CAN'T join if...

  • Candidate for potentially curative therapies in the opinion of the investigator.
  • Previous treatment with a PI3K inhibitor or BTK inhibitor.
  • Prior history of allogeneic hematopoietic stem cell transplant (HSCT).
  • Prior chemotherapy, cancer immunosuppressive therapy, or other investigational agents within 4 weeks before first dose of study drug.
  • Grade 3B FL and/or clinical evidence of transformation to a more aggressive subtype of lymphoma.
  • Symptomatic central nervous system (CNS) NHL.
  • Ongoing systemic bacterial, fungal, or viral infections at the time of initiation of study treatment.
  • Prior, current, or chronic hepatitis B or hepatitis C infection, positive result for hepatitis C virus antibodies (HCV Ab) or hepatitis B surface antigen (HBsAg) or hepatitis B core antibodies (HBcAb)
  • History of stroke, unstable angina, myocardial infarction, or ventricular arrhythmia requiring medication or mechanical control within the last 6 months prior to first dose of study drug

Locations

  • Los Angeles California 90095-6984 United States
  • Whittier California 90603 United States

Details

Status
in progress, not accepting new patients
Start Date
Completion Date
(estimated)
Sponsor
Verastem, Inc.
ID
NCT01882803
Phase
Phase 2
Study Type
Interventional
Last Updated