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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.
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
- 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