OncoMatch/Clinical Trials/NCT07388563
Azacitidine and Abatacept in Relapsed or Refractory T-Cell Lymphoma
Is NCT07388563 recruiting? Yes, currently enrolling (May 2026). This Phase 1 trial studies multiple treatments including azacitidine and abatacept for lymphoma, t cell, peripheral.
Treatment: azacitidine · abatacept — 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....
Check if I qualifyExtracted eligibility criteria
Cancer type
Non-Hodgkin Lymphoma
Acute Lymphoblastic Leukemia
Performance status
ECOG 0–2(Ambulatory, capable of self-care)
Prior therapy
Must have received: systemic therapy
Participants must have a disease that is relapsed or refractory after initial systemic treatment.
Cannot have received: anti-cancer therapy
Exception: 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
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.
Cannot have received: investigational therapy
Any investigational therapy within 2 weeks prior to the study treatment initiation.
Lab requirements
Blood counts
ANC >= 1,000 cells/mcL OR >= 500 cells/mcL if bone marrow involvement with lymphoma; Platelets >= 50,000 cells/mcL OR >= 25,000 cells/mcL if bone marrow involvement with lymphoma; Hemoglobin >= 8 g/dL (transfusions permitted)
Kidney function
Serum creatinine <= 2 mg/dL OR GFR >= 40 mL/min/1.73 m^2 as estimated by MDRD. No limit if involved by lymphoma.
Liver function
Total bilirubin <= 1.5 x ULN; AST <= 3.0 x ULN; ALT <= 3.0 x ULN; PT <1.5 x ULN; aPTT <1.5 x ULN (<5.0 x ULN if prolonged because of a positive Lupus Anticoagulant); INR <1.5 x ULN
Participants must have adequate organ and marrow function as defined below: * Absolute neutrophil count (ANC) / >= 1,000 cells/mcL OR >= 500 cells/mcL if bone marrow involvement with lymphoma * Platelets / >= 50,000 cells/mcL OR >= 25,000 cells/mcL if bone marrow involvement with lymphoma * Hemoglobin / >= 8 g/dL (transfusions permitted) * Renal function / Serum creatinine <= 2 mg/dL OR Glomerular filtration rate (GFR) >= 40 mL/min/1.73 m^2 as estimated by the Modification of Diet in Renal Disease (MDRD). Note: there is no limit if involved by lymphoma. If not on target, a 24-hour urine creatinine clearance can be used to directly measure creatinine clearance. * Total bilirubin / <= 1.5 x upper limit of normal (ULN) * Aspartate Aminotransferase (AST) / <= 3.0 x ULN * Alanine Aminotransferase (ALT) / <= 3.0 x ULN * Prothrombin time (PT) / <1.5 x ULN * Activated partial thromboplastin time (aPTT) / <1.5 x ULN; < 5.0 x ULN if the aPTT is prolonged because of a positive Lupus Anticoagulant International normalized ratio (INR) / <1.5 x ULN
Structured fields extracted by AI. May contain errors — verify against the official protocol.
US trial sites
- National Institutes of Health Clinical Center · Bethesda, Maryland
Showing up to 5 US sites. See all sites on ClinicalTrials.gov →
Could you qualify for this trial?
Enter your biomarker results to see how this trial's eligibility criteria match your specific cancer profile.
Check if I qualify