Study Details

Open

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

This study is being done to answer the following question: What are the effects (good or bad) of adding a study drug (duvelisib or CC-486 (azacitidine)) to the usual combination of drugs? We are doing this study because we want to find out if this approach is better or worse than the usual approach for T-cell lymphoma. The usual approach is defined as care most people get for peripheral T-cell lymphoma.

Age & Gender

18 years ~ 99 years
Male, Female, Gender Inclusive

Visit Availability

Standard business hours (M-F, 8-5)

Location

United States (Nationwide)

What will be asked of you

If enrolled, you will either get the usual chemotherapy for up to 18 weeks, OR you will get the usual chemotherapy plus the study drug duvelisib for up to 18 weeks, OR you will get the usual chemotherapy plus the study drug CC-486 (azacitidine) for up to 18 weeks. To monitor your safety and health you will need to have regular blood tests during treatment, regular CT scans, and a bone marrow biopsy before and after treatment. You will be asked to fill out 10 minute questionnaires at regular intervals during your treatment.

Incentives

You will not have to pay for the non-FDA approved investigational study drugs duvelisib or CC-486 (azacitidine) while you take part in this study

In-person visits:
8

Total length of participation:
4 month treatment and 5 year follow-up

Looking for Specific Volunteers

Able to participate:

You have peripheral T-cell lymphoma with less than 10% CD30 expression
Your T-cell lymphoma has been diagnosed as one of the following subtypes: Nodal T-cell lymphoma with T-follicular helper phenotype, follicular T-cell lymphoma, PTCL-NOS, AITL, enteropathy
You have not had any therapy or radiation therapy for T-cell lymphoma, other than corticosteroids
You are over 18 years old

Not eligible if:

You have had prior systemic therapy for T-cell lymphoma, other than corticosteroids
You have been diagnosed with Human T-lyphotrophic virus (HTLV) type 1 or type 2
Within the past 6 months you have experienced serious heart disease, such as a heart attack, congestive heart faliure, unstable angina, or angina that required

Contact the Team

Visit Location

Contact & Visit Location

Primary Contact

Lineberger Clinical Research
cancerclinicaltrials@med.unc.edu
(919) 966-4432

Primary Visit Location

Lineberger Comprehensive Cancer Center
NC Cancer Hospital (Basnight)
UNC Hospitals / UNC Medical Center
101 Manning Dr, Chapel Hill, NC 27514, USA

Additional Study Information

Principal Investigator

Anne Beaven
LCCC - Clinical Trials

Study Type

Clinical or Medical
Interventional

Study Topics

Cancer (Lymphoma)

IRB Number

22-1274

ClinicalTrials.gov

NCT04803201