A Two-arm, Phase 1b/2 Study of Duvelisib Administered in Combination With Rituximab or Obinutuzumab in Subjects With Previously Untreated CD20+ Follicular Lymphoma (CONTEMPO)

IPI-145-19

A Two-arm, Phase 1b/2 Study of duvelisib Administered in Combination with Rituximab or Obinutuzumab in Subjects with Previously Untreated CD20+ Follicular Lymphoma.

2014-12-01

2017-01-17

2017-05-01

Terminated

Early phase I

55

Inclusion Criteria: * Diagnosis of CD20+, follicular lymphoma that has not been treated * CD20-immunophenotyping of tumor to document B-cell follicular lymphoma * Stage II disease with bulky disease (≥ 7cm lesion), Stage III, or Stage IV disease * Disease that requires treatment based on the Investigator's opinion (e.g., meets GELF criteria) * At least one measurable lesion that is \> 1.5 cm in at least one dimension * Eastern Cooperative Oncology Group (ECOG) performance status \<=2 (corresponds to Karnofsky Performance Status \[KPS\] \>=60%) Exclusion Criteria: * Received systemic treatment for lymphoma such as chemotherapy, immunotherapy, radiotherapy, investigational agents, or radioimmunotherapy. * Clinical evidence of transformation to a more aggressive subtype of lymphoma or grade 3B follicular lymphoma * Severe allergic or anaphylactic reaction to any monoclonal antibody therapy, murine protein, or known hypersensitivity to any of the study drugs * Prior allogeneic hematopoietic stem cell transplant * Prior, current or chronic hepatitis B or hepatitis C infection * Human immunodeficiency virus (HIV) infection or Human T Cell Lymphotropic Virus 1 (HTLV-1) infection

{'studyType': 'INTERVENTIONAL', 'phases': ['PHASE1', 'PHASE2'], 'designInfo': {'allocation': 'RANDOMIZED', 'interventionModel': 'PARALLEL', 'primaryPurpose': 'TREATMENT', 'maskingInfo': {'masking': 'NONE'}}, 'enrollmentInfo': {'count': 55, 'type': 'ACTUAL'}}

2023-09-28