Status:
COMPLETED
A Study of Duvelisib in Participants With Refractory Indolent Non-Hodgkin Lymphoma
Lead Sponsor:
SecuraBio
Conditions:
Indolent Non-Hodgkin Lymphoma
Eligibility:
All Genders
18+ years
Phase:
PHASE2
Brief Summary
This was a Phase 2 clinical trial to evaluate the safety and efficacy of duvelisib as a monotherapy in participants with indolent non-Hodgkin lymphoma (iNHL) (follicular lymphoma \[FL\], marginal zone...
Detailed Description
This was an open-label, single-arm safety and efficacy study of duvelisib administered orally to participants who had been diagnosed with iNHL whose disease was refractory to rituximab and to either c...
Eligibility Criteria
Inclusion
- Participants who had been diagnosed with iNHL that had progressed.
- Participants must have exhibited lack of CR or progressive disease (PR) or progression within 6 months after the last dose of a chemotherapy induction regimen or RIT.
- Participants must have had 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 centimeters in at least one dimension by computed tomography (CT), positron emission tomography/CT or magnetic resonance imaging.
- Adequate renal and hepatic function.
Exclusion
- Candidate for potentially curative therapies in the opinion of the investigator.
- Previous treatment with a PI3K inhibitor or Bruton's tyrosine kinase inhibitor.
- Prior history of allogeneic hematopoietic stem cell transplant.
- 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 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, hepatitis B surface antigen, or hepatitis B core antibodies.
- 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.
Key Trial Info
Start Date :
June 17 2013
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
November 18 2020
Estimated Enrollment :
129 Patients enrolled
Trial Details
Trial ID
NCT01882803
Start Date
June 17 2013
End Date
November 18 2020
Last Update
September 7 2023
Active Locations (69)
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1
Los Angeles, California, United States, 90095-6984
2
Whittier, California, United States, 90603
3
Denver, Colorado, United States, 80218
4
Fort Myers, Florida, United States, 39916