Overview

This trial is active, not recruiting.

Condition follicular lymphoma
Treatments ipi-145 (duvelisib), placebo, rituximab
Phase phase 3
Targets PI3K, CD20
Sponsor Infinity Pharmaceuticals, Inc.
Start date September 2014
End date January 2019
Trial size 400 participants
Trial identifier NCT02204982, 2013-002406-31, IPI-145-08

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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification efficacy study
Intervention model parallel assignment
Masking double blind (subject, caregiver, investigator, outcomes assessor)
Primary purpose treatment
Arm
(Experimental)
IPI-145 is administered orally and supplied as 5 mg and 25 mg formulated capsules. Rituximab is administered as an intravenous (IV) infusion and is supplied in single-use vials at two strengths, 100 mg and 500 mg.
ipi-145 (duvelisib)
IPI-145 (25 mg BID) administered orally in 28-day continuous treatment cycles
rituximab Rituxan
IV infusion of rituximab (375 mg/m2) once weekly for 4 weeks during Cycle 1, then once on Day 1 of Cycles 4, 6, 8, and 10.
(Placebo Comparator)
Placebo is administered orally and supplied as formulated capsules to match the active 5 mg and 25 mg capsules. Rituximab is administered as an intravenous (IV) infusion and is supplied in single-use vials at two strengths, 100 mg and 500 mg.
placebo
Matching Placebo (25 mg BID) administered orally in 28-day continuous treatment cycles.
rituximab Rituxan
IV infusion of rituximab (375 mg/m2) once weekly for 4 weeks during Cycle 1, then once on Day 1 of Cycles 4, 6, 8, and 10.

Primary Outcomes

Measure
Progression-Free Survival (PFS)
time frame: Until disease progression, for up to 5 years from randomization

Secondary Outcomes

Measure
Overall Response Rate (ORR)
time frame: Until disease progression, for up to 5 years from randomization
Overall Survival (OS)
time frame: Every 6 months for up to 7 years from randomization
Duration of Response (DOR)
time frame: Until disease progression, for up to 5 years from randomization
Treatment- emergent adverse events (TEAEs) and changes in safety laboratory values
time frame: 30 days from last dose
Plasma concentrations of IPI-145 and its metabolite(s)
time frame: Every 4 weeks for 12 weeks

Eligibility Criteria

Male or female participants at least 18 years old.

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

Additional Information

Official title A Randomized, Double-Blind, Placebo-Controlled Phase 3 Study of Duvelisib in Combination With Rituximab vs Rituximab in Subjects With Previously Treated Follicular Lymphoma
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.
Trial information was received from ClinicalTrials.gov and was last updated in June 2016.
Information provided to ClinicalTrials.gov by Infinity Pharmaceuticals, Inc..
Location data was received from the National Cancer Institute and was last updated in June 2016.