Azacitidine and Abatacept in Relapsed or Refractory T-Cell Lymphoma (NCT07388563) | Clinical Trial Compass
SuspendedPhase 1
Azacitidine and Abatacept in Relapsed or Refractory T-Cell Lymphoma
Stopped: New recruitment on hold for a protocol design amendment/modification.
United States20 participantsStarted 2026-03-26
Plain-language 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....
Who can participate
Age range18 Years – 120 Years
SexALL
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Inclusion criteria
✓. Participants must have a histologically or cytologically confirmed T-cell lymphoma confirmed by the Laboratory of Pathology (LP), NCI. The one of the following T-cell lymphomas are included:
✓. Participants must have a disease that is relapsed or refractory after initial systemic treatment.
✓. Participants must have evaluable disease on screening imaging or by laboratory assessment.
✓. Age \>= 18 years.
✓. ECOG performance status \<= 2.
✓. Participants must have adequate organ and marrow function as defined below:
✓. Participants, seropositive for human immunodeficiency virus (HIV), must have an undetectable HIV viral load.
✓. Participants, seropositive for hepatitis C virus (HCV) infection, must have been treated and have an undetectable HCV viral load.
Exclusion criteria
✕. Any second malignancy that requires current active systemic therapy.
What they're measuring
1
Arm 2: To estimate the CRR of the combination of azacitidine and abatacept.
Timeframe: Day 1 of Cycles 1, 4, 7, 10, EOT/PD visit, every 3 months for years 1-2, every 6 months for years 3-4, once a year for year 5.
2
Arm 1: To estimate the MTD of the combination of azacitidine and abatacept in relapsed or refractory T-cell lymphoma.
✕. Active systemic bacterial, viral, fungal, mycobacterial, parasitic, or other infection requiring anti-infective treatment within 1 day prior to the study treatment initiation.
✕. Anti-cancer therapy within 2 weeks prior to the study treatment initiation. Note: systemic steroids are allowed if \<= 100 mg/per day of prednisone (or equivalent) and were used for \<= 7 days during 2 weeks before the study treatment initiation.
✕. Any investigational therapy within 2 weeks prior to the study treatment initiation.
✕. Known allergy or hypersensitivity to any of the study drugs.
✕. Pregnancy confirmed with beta-human chorionic gonadotropin (beta-HCG) serum or urine pregnancy test in WOCBP at screening.
✕. Active central nervous system involvement with lymphoma. Previously treated central nervous system involvement with lymphoma will be allowed if \>3 months since end of treatment.