A Study of Duvelisib in Combination With Rituximab or Obinutuzumab in Subjects With Previously Untreated CD20+ Follicular Lymphoma (CONTEMPO)

• Status: Terminated
• Trial end date: 2017-05-01
• Target enrollment: 0
• Participant gender: All

Summary

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

• Phase: Phase 1/Phase 2
• Accepts Healthy Volunteers?: No

Details

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

Criteria

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