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

• Status: Terminated
• Trial end date: 2017-03-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Infinity Pharmaceuticals, Inc.; SecuraBio
• Treatments: Rituximab

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