Clinical trial NCT02204982 (phase 3, status: terminated)
Conditions: follicular lymphoma
ICD codes: S33.110S, S33.111S, S33.120S, S33.121S, S33.130S, S33.131S, S33.140S
Drugs: duvelisib, placebo, rituximab
SMILES: C[C@H](NC1=C2N=CNC2=NC=N1)C1=CC2=CC=CC(Cl)=C2C(=O)N1C1=CC=CC=C1, CN1C(=O)C=C(N2CCC[C@@H](N)C2)N(CC2=C(C=CC=C2)C#N)C1=O, ClCCN(CCCl)P1(=O)NCCCO1
Reason stopped: 
    sponsor is focusing on studies which can enable registration of duvelisib
  
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