A Phase 2 Study of Duvelisib in Subjects With Refractory Indolent Non-Hodgkin Lymphoma (DYNAMO)

• Status: Active, not recruiting
• Trial end date: 2021-10-20
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Infinity Pharmaceuticals, Inc.; SecuraBio

Criteria

Inclusion Criteria:

• 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.

Exclusion Criteria:

• 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