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Testing the Addition of Duvelisib or CC-486 to the Usual Treatment for Peripheral T-Cell Lymphoma


Title 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
Therapeutic Area Lymphomas (adult)
Principal Investigator Yun Choi
Min Age 18 Years
Gender Any
Contact Sarah Sexton
617-636-3264
ncccr@tuftsmedicalcenter.org
More Information https://clinicaltrials.gov/ct2/show/NCT04803201

Overview

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. 

Study Details

Inclusion Criteria

1. 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

2. Measurable disease as defined by the Lugano criteria

3. No prior systemic therapy for lymphoma (excluding corticosteroids)

Exclusion Criteria

1. No prior systemic therapy for lymphoma (excluding corticosteroids). 

2. Patients with expression of CD30 in >= 10% of the tumor (based on local immunohistochemistry review) regardless of histology will not be permitted. 

3. 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