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RECRUITING
NCT07388563
PHASE1

Azacitidine and Abatacept in Relapsed or Refractory T-Cell Lymphoma

Sponsor: National Cancer Institute (NCI)

View on ClinicalTrials.gov

Summary

Background: T-cell lymphoma is a blood cancer that affects immune system cells. People tend to survive less than 1 year if this disease does not respond to treatment (is refractory) or comes back after treatment (relapses). Azacitidine and abatacept are 2 drugs that are used to treat other diseases. Researchers want to know if these drugs, used together, can help people with T-cell lymphoma. Objective: To learn if azacitidine combined with abatacept can shrink tumors in people with T-cell lymphoma. Eligibility: People aged 18 years and older with T-cell lymphoma that either came back or did not respond to treatment. Design: Participants will be screened. They will have a physical exam with blood tests. They will have a test of their heart function. They will have imaging scans of their tumors. A sample of tumor tissue may be taken. Azacitidine is injected under the skin of the thigh, abdomen, or upper arm. Abatacept is infused through a needle inserted into a vein in the arm. Participants will receive the study drugs in 28-day cycles for up to 13 cycles. They will come to the clinic for each treatment. They will come to the clinic on day 1 and day 15 of the first cycle. After that, they will come to the clinic on the first 5 or 7 days of each cycle. Each clinic visit will take no more than 8 hours. Imaging scans and other tests will be repeated during the study. Participants will have follow-up visits for up to 5 years after they stop taking the study drugs....

Official title: A Phase I Trial of Azacitidine and Abatacept in Relapsed or Refractory T-Cell Lymphoma

Key Details

Gender

All

Age Range

18 Years - 120 Years

Study Type

INTERVENTIONAL

Enrollment

20

Start Date

2026-03-26

Completion Date

2027-12-31

Last Updated

2026-03-31

Healthy Volunteers

No

Interventions

DRUG

azacitidine

Days 1-5 or 1-7 of every cycle (12 cycles): azacitidine subcutaneous or IV at the dose of 75 mg/m2

DRUG

abatacept

Cycle 0, Days 1 and 15: abatacept IV infusions at the dose of 5 mg/kg or 10 mg/kg. Cycles 1-6, Day 1: abatacept IV infusions at the dose of 5 mg/kg or 10 mg/kg.

Locations (1)

National Institutes of Health Clinical Center

Bethesda, Maryland, United States