A Study of Duvelisib in Combination With Rituximab or Obinutuzumab in Subjects With Previously Untreated CD20+ Follicular Lymphoma (CONTEMPO)
Trial ID or NCT#
A Two-arm, Phase 1b/2 Study of duvelisib Administered in Combination with Rituximab or Obinutuzumab in Subjects with Previously Untreated CD20+ Follicular Lymphoma.
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)
- - 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%)
- - 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
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