Study of Duvelisib in Combination With Rituximab vs Rituximab in Subjects With Previously Treated Follicular Lymphoma

NCT ID: NCT02204982

Last Updated: 2023-09-28

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: PHASE3
• Total Enrollment: 13 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2014-09-30
• Study Completion Date: 2017-03-31

Brief Summary

A study to evaluate the safety and efficacy of duvelisib 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 duvelisib 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 duvelisib 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.

Conditions

Follicular Lymphoma

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: QUADRUPLE

Study Groups

Duvelisib + Rituximab

Duvelisib 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.

Group Type: EXPERIMENTAL

Duvelisib

Intervention Type: DRUG

PI3K Inhibitor

Rituximab

Intervention Type: DRUG

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 + Rituximab

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.

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: DRUG

Matching Placebo (25 mg BID) administered orally in 28-day continuous treatment cycles.

Rituximab

Intervention Type: DRUG

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.

Interventions

Duvelisib

PI3K Inhibitor

Intervention Type: DRUG

Placebo

Matching Placebo (25 mg BID) administered orally in 28-day continuous treatment cycles.

Intervention Type: DRUG

Rituximab

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.

Intervention Type: DRUG

Other Intervention Names

Copiktra, IPI-145; Rituxan; MabThera

Eligibility 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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

SecuraBio

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Hagop Youssoufian, MD

Role: STUDY_CHAIR

Verastem, Inc.

Locations

Frankston, Victoria, Australia

Bordeaux, , France

Bologna, , Italy

Terni, , Italy

Gdynia, , Poland

Countries

Australia; France; Italy; Poland

Other Identifiers

2013-002406-31

Identifier Type: EUDRACT_NUMBER

Identifier Source: secondary_id

IPI-145-08

Identifier Type: -

Identifier Source: org_study_id