OncoMatch/Clinical Trials/NCT07388563
Azacitidine and Abatacept in Relapsed or Refractory T-Cell Lymphoma
Official title: A Phase I Trial of Azacitidine and Abatacept in Relapsed or Refractory T-Cell Lymphoma
Is NCT07388563 recruiting? Yes, currently enrolling (Oct 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
Treatments studied
Chemotherapy
Other
Cancer type
Non-Hodgkin Lymphoma
Acute Lymphoblastic Leukemia
Performance status
ECOG 0–2(Ambulatory, capable of self-care)
Demographics
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 →Frequently asked questions
Is NCT07388563 currently recruiting?
Yes, this trial is currently recruiting patients.
Are there prior therapy exclusions?
Yes. Prior anti-cancer therapy, investigational therapy disqualifies patients from enrollment.
Is there an age limit?
Yes. Patients must be 120 years or younger.
Could you qualify for this trial?
Enter your biomarker results to see how this trial's eligibility criteria match your specific cancer profile.
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