Study of Duvelisib in Combination With Rituximab vs Rituximab in Subjects With Previously Treated Follicular Lymphoma
Conditions
Follicular Lymphoma
Conditions: official terms
Lymphoma - Lymphoma, Follicular
Conditions: Keywords
Phase 3, Follicular Lymphoma, FL, PI3K
Study Type
Interventional
Study Phase
Phase 3
Study Design
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment
Intervention
Name: IPI-145 (duvelisib) Type: Drug
Name: Placebo Type: Drug
Name: Rituximab Type: Drug
Overall Status
Recruiting
Summary
A study to evaluate the safety and efficacy of IPI 145 administered in combination with rituximab vs placebo in combination with rituximab in patients with previously treated CD20-positive follicular lymphoma who are not suitable candidates for chemotherapy.
Detailed Description
Study IPI-145-08 is an international, multicenter, randomized, double-blind, placebo-controlled, parallel-group, Phase 3 study designed to evaluate the efficacy and safety of IPI-145 in combination with rituximab vs placebo in combination with rituximab in subjects with previously treated CD20-positive follicular lymphoma.

Approximately 400 subjects will receive 25 mg of IPI-145 or placebo, orally BID for 28 day continuous cycles, in combination with 375 mg/m2 of Rituximab given once weekly for 4 weeks during Cycle 1 and then once on Day 1 of Cycles 4, 6, 8, and 10. Patients will remain on treatment for up to 27 cycles and may continue treatment if clinical benefit is observed.
Criteria for eligibility
Healthy Volunteers: No
Maximum Age: N/A
Minimum Age: 18 Years
Gender: Both
Criteria: Inclusion Criteria:

- Diagnosis of CD20-positive FL:

- Histology grades 1, 2 or 3a

- Biopsy-confirmed histopathological diagnosis of FL. Biopsy specimen should be obtained ≤2 years prior to randomization, unless medically contraindicated

- CD20 immunophenotyping performed ≤2 years prior to randomization

- First or subsequent relapse following at least one induction therapy regimen containing rituximab in combination with an anthracycline or rituximab in combination with an alkylating agent

- Patients in first relapse must be chemoresistant or intolerant to chemotherapy

- No response or disease progression ≤ 24 months from start of last previous therapy

- At least 1 measurable disease lesion >1.5 cm in at least one diameter by CT/CT-PET or magnetic resonance imaging (MRI) in an area of no prior radiation therapy, or in an area that was previously irradiated that has documented progression

Exclusion Criteria:

- Clinical evidence of other indolent forms of lymphoma (e.g., marginal zone lymphoma [MZL], small lymphocytic lymphoma [SLL])

- Transformation to a more aggressive subtype of lymphoma or grade 3b FL

- Refractory to rituximab: defined as disease progression while receiving or within 6 months of completing either weekly rituximab induction therapy, or rituximab-based chemoimmunotherapy induction

- Intolerance to rituximab or severe allergic or anaphylactic reaction to any humanized or murine monoclonal antibodies

- Prior allogeneic hematopoietic stem cell transplant (HSCT)

- Known Central Nervous System (CNS) lymphoma; subjects with symptoms of CNS disease must have a negative CT scan and negative diagnostic lumbar puncture

- Prior treatment with a PI3K inhibitor or BTK inhibitor

- History of tuberculosis within the preceding two years

- Ongoing systemic bacterial, fungal, or viral infections at randomization (defined as requiring IV antimicrobial, antifungal or antiviral agents)

- Subjects on antimicrobial, antifungal or antiviral prophylaxis are not specifically excluded if all other I/E criteria are met

- Prior, current, or chronic hepatitis B or hepatitis C infection, positive result for hepatitis B surface antigen (HBsAg) or hepatitis B core antibody (HBcAb) or hepatitis C virus antibodies (HCV Ab)

- History of stroke, unstable angina, myocardial infarction, or ventricular arrhythmia requiring medication or mechanical control within the last 6 months
Locations
Anaheim, California, United States
Status: Recruiting
Fountain Valley, California, United States
Status: Terminated
LaJolla, California, United States
Status: Recruiting
Orange, California, United States
Status: Recruiting
San Diego, California, United States
Status: Recruiting
Gainesville, Florida, United States
Status: Recruiting
Miami Beach, Florida, United States
Status: Terminated
Boise, Idaho, United States
Status: Terminated
Chicago, Illinois, United States
Status: Recruiting
Topeka, Kansas, United States
Status: Recruiting
New Orleans, Louisiana, United States
Status: Terminated
Baltimore, Maryland, United States
Status: Terminated
Novi, Michigan, United States
Status: Terminated
Kansas City, Missouri, United States
Status: Recruiting
Cherry Hill, New Jersey, United States
Status: Recruiting
Hackensack, New Jersey, United States
Status: Recruiting
Howell, New Jersey, United States
Status: Recruiting
Little Silver, New Jersey, United States
Status: Recruiting
Morristown, New Jersey, United States
Status: Recruiting
Farmington, New Mexico, United States
Status: Recruiting
Syracuse, New York, United States
Status: Recruiting
Goldsboro, North Carolina, United States
Status: Recruiting
Pittsburgh, Pennsylvania, United States
Status: Recruiting
Cookeville, Tennessee, United States
Status: Recruiting
Dallas, Texas, United States
Status: Recruiting
Spokane, Washington, United States
Status: Recruiting
Charleston, West Virginia, United States
Status: Terminated
Concord, Tasmania, Australia
Status: Recruiting
Hobart, Tasmania, Australia
Status: Recruiting
Clayton, Victoria, Australia
Status: Recruiting
Coburg Melbourne, Victoria, Australia
Status: Recruiting
Frankston, Victoria, Australia
Status: Recruiting
Wendouree, Victoria, Australia
Status: Recruiting
Steyr, Austria
Status: Recruiting
Antwerpen, Belgium
Status: Recruiting
Brussels, Belgium
Status: Recruiting
Charleroi, Belgium
Status: Recruiting
Leuven, Belgium
Status: Terminated
Roeselare, Belgium
Status: Recruiting
Yvoir, Belgium
Status: Recruiting
Greenfield Park, Quebec, Canada
Status: Recruiting
Montreal, Quebec, Canada
Status: Recruiting
Ottowa, Canada
Status: Recruiting
Prague, Czech Republic
Status: Recruiting
Prague, Czech Republic
Status: Recruiting
Praha, Czech Republic
Status: Recruiting
Arhus, Denmark
Status: Recruiting
Hostelbro, Denmark
Status: Recruiting
Argenteuil, France
Status: Recruiting
Bordeaux, France
Status: Recruiting
Brest, France
Status: Recruiting
Cedex, France
Status: Recruiting
Limoges Cedex, France
Status: Recruiting
Toulouse cedex 9, France
Status: Recruiting
Vandoeuvre, France
Status: Recruiting
Berlin, Germany
Status: Recruiting
Berlin, Germany
Status: Recruiting
Erlangen, Germany
Status: Recruiting
Munich, Germany
Status: Recruiting
Villingen-Schwenningen, Germany
Status: Recruiting
Budapest, Hungary
Status: Terminated
Budapest, Hungary
Status: Recruiting
Debrecen, Hungary
Status: Recruiting
Győr, Hungary
Status: Terminated
Pecs, Hungary
Status: Terminated
Szeged, Hungary
Status: Recruiting
Szolnok, Hungary
Status: Recruiting
Tallián Gyula, Hungary
Status: Terminated
Haifa, Israel
Status: Recruiting
Haifa, Israel
Status: Recruiting
Jerusalem, Israel
Status: Recruiting
Aviano, Italy
Status: Recruiting
Bologna, Italy
Status: Recruiting
Brescia, Italy
Status: Recruiting
Lecce, Italy
Status: Recruiting
Meldola, Italy
Status: Recruiting
Milano, Italy
Status: Recruiting
Ravenna, Italy
Status: Recruiting
Rimini, Italy
Status: Recruiting
Rome, Italy
Status: Recruiting
Terni, Italy
Status: Recruiting
Christchurch, New Zealand
Status: Recruiting
Gdynia, Poland
Status: Recruiting
Krakow, Poland
Status: Recruiting
Lodz, Poland
Status: Recruiting
Warszawa, Poland
Status: Recruiting
Wroclaw, Poland
Status: Recruiting
Barcelona, Spain
Status: Recruiting
Barcelona, Spain
Status: Recruiting
Coruna, Spain
Status: Recruiting
Madrid, Spain
Status: Recruiting
Madrid, Spain
Status: Recruiting
Salamanca, Spain
Status: Recruiting
Sevilla, Spain
Status: Recruiting
Cornwall, United Kingdom
Status: Recruiting
Harrow Middlesex, United Kingdom
Status: Recruiting
Leeds, United Kingdom
Status: Recruiting
London, United Kingdom
Status: Recruiting
Plymouth, United Kingdom
Status: Recruiting
Start Date
September 2014
Completion Date
January 2024
Sponsors
Infinity Pharmaceuticals, Inc.
Source
Infinity Pharmaceuticals, Inc.
Record processing date
ClinicalTrials.gov processed this data on July 28, 2015
ClinicalTrials.gov page