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

NCT04803201 · Status: SUSPENDED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 170

Last updated 2026-05-06

No results posted yet for this study

Summary

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. Chemotherapy drugs, such as CC-486, cyclophosphamide, doxorubicin, vincristine, etoposide and prednisone, work in different ways to stop the growth of cancer cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. This trial may help find out if this approach is better or worse than the usual approach for treating peripheral T-cell lymphoma.

Conditions

  • Angioimmunoblastic T-cell Lymphoma
  • Enteropathy-Associated T-Cell Lymphoma
  • Follicular T-Cell Lymphoma
  • Mature T-Cell and NK-Cell Non-Hodgkin Lymphoma
  • Monomorphic Epitheliotropic Intestinal T-Cell Lymphoma
  • Nodal Peripheral T-Cell Lymphoma With TFH Phenotype
  • Peripheral T-Cell Lymphoma, Not Otherwise Specified

Interventions

DRUG

Cyclophosphamide

Given IV

DRUG

Doxorubicin

Given IV

DRUG

Vincristine

Given IV

DRUG

Prednisone

Given PO

DRUG

Etoposide

Given IV or PO

DRUG

Duvelisib

Given PO

DRUG

Oral azacitidine

Given PO

Sponsors & Collaborators

Principal Investigators

  • Neha Mehta-Shah, MD, MSCI · Washington University School of Medicine

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2021-10-08
Primary Completion
2027-05-19
Completion
2027-05-19
FDA Drug
Yes

Countries

  • United States

Study Locations

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Entities

Drugs
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04803201 on ClinicalTrials.gov