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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

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Lymphomas (adult)
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All genders
person-wave 18+
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Overview

Principal Investigator: Yun Choi

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.

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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

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