Non Hodgkin Lymphoma Clinical Trial

A Study of Duvelisib in Participants With Refractory Indolent Non-Hodgkin Lymphoma


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.

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Full 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 chemotherapy or RIT.

Approximately 120 participants received 25 milligrams of duvelisib twice daily over the course of 28-day treatment cycles for up to 13 cycles.

After completing 13 treatment cycles of duvelisib, participants continued to receive additional cycles of duvelisib until disease progression or unacceptable toxicity. However, to receive additional cycles of duvelisib beyond 13 cycles, participants must have had evidence of response (complete response [CR] or partial response [PR]) or stable disease according to the International Working Group criteria by the end of Cycle 13.

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Eligibility Criteria

Inclusion Criteria:

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 Criteria:

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.

Study is for people with:

Non Hodgkin Lymphoma


Phase 2

Estimated Enrollment:


Study ID:


Recruitment Status:




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There are 68 Locations for this study

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Los Angeles California, 90095, United States

Whittier California, 90603, United States

Denver Colorado, 80218, United States

Fort Myers Florida, 39916, United States

Saint Petersburg Florida, 33705, United States

Tallahassee Florida, 32308, United States

Atlanta Georgia, 30322, United States

Chicago Illinois, 60637, United States

Louisville Kentucky, 40207, United States

Baltimore Maryland, 21204, United States

Baltimore Maryland, 21229, United States

Boston Massachusetts, 02215, United States

Saint Louis Missouri, 63110, United States

Howell New Jersey, 07731, United States

Morristown New Jersey, 07962, United States

New York New York, 10021, United States

Rockville Centre New York, 11510, United States

Canton Ohio, 44718, United States

Lawton Oklahoma, 73505, United States

Oklahoma City Oklahoma, 73104, United States

Philadelphia Pennsylvania, 01911, United States

Nashville Tennessee, 37203, United States

Dallas Texas, 75246, United States

Lynchburg Virginia, 24501, United States

Lesnoy Minsk Region, 22304, Belarus

Brest , 22402, Belarus

Minsk , 22001, Belarus

Vitebsk , 21060, Belarus

Gent , 9000, Belgium

Kortrijk , 8500, Belgium

Sofia , 1233, Bulgaria

Sofia , 1407, Bulgaria

Sofia , 1431, Bulgaria

Sofia , 1756, Bulgaria

Toronto Ontario, M5G 2, Canada

Gatineau Quebec, J8P7H, Canada

Montreal Quebec, H3T 1, Canada

Brno , 625-0, Czechia

Ostrava-Poruba , 708-5, Czechia

Angers Cedex 09 , 49933, France

Bordeaux , 33076, France

Clermont-Ferrand , 63000, France

Marseille , 13005, France

Pierre Benite , 69495, France

Tbilisi , 0186, Georgia

Budapest , 1083, Hungary

Budapest , 1122, Hungary

Debrecen , 4032, Hungary

Bologna , 40138, Italy

Brescia , 25123, Italy

Busto Arsizio , 21052, Italy

Genova , 16132, Italy

Meldola , 47014, Italy

Milano , 20162, Italy

Modena , 41124, Italy

Orbassano , 10043, Italy

Parma , 43100, Italy

Ravenna , 48121, Italy

Rimini , 47923, Italy

Varese , 21100, Italy

Barcelona , 08036, Spain

Madrid , 28222, Spain

Salamanca , 37007, Spain

Cardiff , CF 14, United Kingdom

Chelsea , , United Kingdom

Liverpool , L7 8X, United Kingdom

London , NW1 2, United Kingdom

London , W1G 6, United Kingdom

Sutton , SM2 5, United Kingdom

How clear is this clinincal trial information?

Study is for people with:

Non Hodgkin Lymphoma


Phase 2

Estimated Enrollment:


Study ID:


Recruitment Status:




How clear is this clinincal trial information?


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