This phase II trial studies the effect of duvelisib or CC-486 and usual chemotherapy consisting of cyclophosphamide, doxorubicin, vincristine, etoposide, and prednisone in treating patients with peripheral T-cell lymphoma. Duvelisib may stop the growth of cancer cells by blocking some of the enzymes needed for cell growth.
Testing the Addition of Duvelisib or CC-486 to the Usual Treatment for Peripheral T-Cell Lymphoma
A051902, A randomized phase II study of CHO(E)P vs CC-486- CHO(E)P vs duvelisib- CHO(E)P in previously untreated CD30 negative peripheral T-cell lymphomas
Lymphomas (adult)
All genders
18+
Recruiting now
Overview
Principal Investigator: Yun Choi
Contact Us
Sarah Sexton
Study details
Inclusion Criteria
- Histologically confirmed diagnosis of peripheral T-cell lymphoma (PTCL) with < 10% CD30 expression by immunohistochemistry in the following subtypes (by local review): nodal T-cell lymphoma with T-follicular helper (TFH) phenotype (TFH-PTCL), follicular T-cell lymphoma, PTCL-not otherwise specified (NOS), angioimmunoblastic T-cell lymphoma (AITL), enteropathy associated T-cell lymphoma, monomorphic epitheliotropic intestinal T-cell lymphoma
- Measurable disease as defined by the Lugano criteria
- No prior systemic therapy for lymphoma (excluding corticosteroids)
Exclusion Criteria
- No prior systemic therapy for lymphoma (excluding corticosteroids).
- Patients with expression of CD30 in >= 10% of the tumor (based on local immunohistochemistry review) regardless of histology will not be permitted.
- Eastern Cooperative Oncology Group (ECOG) performance status =< 2
Study Requirements
Protocol therapy will consist of 6 cycles administered every 21 days. Patients who are age ≤ 60 years at the time of registration will receive CHOEP chemotherapy. Those who are over 60 years old at the time of registration will receive CHOP chemotherapy.
Imaging at Baseline, Post-Cycle 4, Post-Cycle 6, Post-treatment Re-staging: PET/CT of the whole body or limited whole body