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.
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.
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.
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.
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There are 68 Locations for this study
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
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