A Phase 2 Study of Duvelisib in Subjects With Refractory Indolent Non-Hodgkin Lymphoma (DYNAMO)
Conditions
Indolent Non-Hodgkin Lymphoma
Conditions: official terms
Lymphoma - Lymphoma, Non-Hodgkin
Conditions: Keywords
PI3K Inhibitor
Study Type
Interventional
Study Phase
Phase 2
Study Design
Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Intervention
Name: IPI-145 (duvelisib)
Type: Drug
Overall Status
Recruiting
Summary
Phase 2 clinical trial to evaluate the safety and efficacy of IPI-145 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.
Detailed Description
This is an open-label, single arm safety and efficacy study of IPI-145 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 IPI-145 BID over the course of 28-day treatment cycles for up to 13 cycles.

After completing 13 treatment cycles of IPI-145, subjects may continue to receive additional cycles of IPI-145 for an additional year for a total of 2 years of treatment. However, to receive additional cycles of IPI-145 beyond 13 cycles, subjects must have evidence of response (CR or PR) according to the IWG criteria1 by the end of Cycle 13.
Criteria for eligibility
Healthy Volunteers: No
Maximum Age: N/A
Minimum Age: 18 Years
Gender: Both
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
Locations
Mobile, Alabama, United States
Status: Recruiting
Glendale, Arizona, United States
Status: Recruiting
Downey, California, United States
Status: Recruiting
La Jolla, California, United States
Status: Recruiting
Los Angeles, California, United States
Status: Recruiting
Oceanside, California, United States
Status: Recruiting
Whittier, California, United States
Status: Recruiting
Denver, Colorado, United States
Status: Recruiting
Fort Myers, Florida, United States
Status: Recruiting
Pensacola, Florida, United States
Status: Withdrawn
St. Petersburg, Florida, United States
Status: Recruiting
Tallahassee, Florida, United States
Status: Recruiting
Atlanta, Georgia, United States
Status: Recruiting
Thomasville, Georgia, United States
Status: Recruiting
Chicago, Illinois, United States
Status: Recruiting
Skokie, Illinois, United States
Status: Recruiting
Louisville, Kentucky, United States
Status: Withdrawn
Baltimore, Maryland, United States
Status: Recruiting
Baltimore, Maryland, United States
Status: Recruiting
Boston, Massachusetts, United States
Status: Recruiting
Duluth, Minnesota, United States
Status: Recruiting
St. Louis, Missouri, United States
Status: Recruiting
Omaha, Nebraska, United States
Status: Withdrawn
Brick, New Jersey, United States
Status: Recruiting
Howell, New Jersey, United States
Status: Recruiting
Morristown, New Jersey, United States
Status: Recruiting
New York, New York, United States
Status: Withdrawn
Canton, Ohio, United States
Status: Recruiting
Cincinnati, Ohio, United States
Status: Withdrawn
Lawton, Oklahoma, United States
Status: Recruiting
Oklahoma City, Oklahoma, United States
Status: Recruiting
Philadelphia, Pennsylvania, United States
Status: Recruiting
Watertown, South Dakota, United States
Status: Recruiting
Chattanooga, Tennessee, United States
Status: Withdrawn
Nashville, Tennessee, United States
Status: Recruiting
Dallas, Texas, United States
Status: Recruiting
Dallas, Texas, United States
Status: Recruiting
Lynchburg, Virginia, United States
Status: Recruiting
Lesnoy, Minsk Region, Belarus
Status: Recruiting
Brest, Belarus
Status: Recruiting
Minsk, Belarus
Status: Recruiting
Vitebsk, Belarus
Status: Recruiting
Charleroi, Belgium
Status: Recruiting
Sofia, Bulgaria
Status: Recruiting
Sofia, Bulgaria
Status: Recruiting
Sofia, Bulgaria
Status: Recruiting
Toronto, Ontario, Canada
Status: Recruiting
Gatineau, Quebec, Canada
Status: Recruiting
Montreal, Quebec, Canada
Status: Recruiting
Brno, Czech Republic
Status: Recruiting
Ostrava-Poruba, Czech Republic
Status: Recruiting
Praha 10, Czech Republic
Status: Recruiting
Amiens Cedex 1, France
Status: Recruiting
Angers Cedex 09, France
Status: Recruiting
Brest Cedex, France
Status: Recruiting
Clermont-Ferrand, France
Status: Recruiting
Marseille, France
Status: Recruiting
Pierre Benite, France
Status: Recruiting
Tbilisi, Georgia
Status: Recruiting
Budapest, Hungary
Status: Recruiting
Budapest, Hungary
Status: Recruiting
Debrecen, Hungary
Status: Recruiting
Bologna, Italy
Status: Recruiting
Brescia, Italy
Status: Recruiting
Busto Arsizio, Italy
Status: Recruiting
Genova, Italy
Status: Recruiting
Meldola, Italy
Status: Recruiting
Milano, Italy
Status: Recruiting
Modena, Italy
Status: Recruiting
Orbassano, Italy
Status: Recruiting
Parma, Italy
Status: Recruiting
Ravenna, Italy
Status: Recruiting
Rimini, Italy
Status: Recruiting
Varese, Italy
Status: Recruiting
Barcelona, Spain
Status: Recruiting
Madrid, Spain
Status: Recruiting
Salamanca, Spain
Status: Recruiting
San Sebastian, Spain
Status: Recruiting
Valencia, Spain
Status: Recruiting
Cardiff, United Kingdom
Status: Recruiting
Chelsea, United Kingdom
Status: Recruiting
Liverpool, United Kingdom
Status: Recruiting
London, United Kingdom
Status: Recruiting
London, United Kingdom
Status: Recruiting
London, United Kingdom
Status: Recruiting
Sutton, United Kingdom
Status: Recruiting
Truro, United Kingdom
Status: Recruiting
Start Date
May 2013
Completion Date
January 2018
Sponsors
Infinity Pharmaceuticals, Inc.
Source
Infinity Pharmaceuticals, Inc.
Record processing date
ClinicalTrials.gov processed this data on July 28, 2015
ClinicalTrials.gov page