Study of Duvelisib in Combination With Rituximab vs Rituximab in Subjects With Previously Treated Follicular Lymphoma
Condition: Follicular Lymphoma
MeSH terms: Lymphoma; Lymphoma, Follicular
Intervention: Duvelisib; Placebo; Rituximab
Intervention description: PI3K Inhibitor; Matching Placebo (25 mg BID) administered orally in 28-day continuous treatment cycles.; 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 MeSH terms: Rituximab
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 13.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Phase 3, Follicular Lymphoma, FL, PI3K

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.
    

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