Azacitidine With Abatacept for Relapsed or Refractory T-Cell Lymphoma

Trial details

Who runs it

National Cancer Institute (NCI)

Trial code

NCT07388563

Record updated

9 November 2026

Original description

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

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....

Exclusion: 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; 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; Any second malignancy that requires current active systemic therapy; Latent tuberculosis (TB) infection; Known allergy or hypersensitivity to any of the study drugs; Uncontrolled intercurrent illness, factors, evaluated by medical history, electrocardiogram (EKG), and physical exam that would potentially increase in risk of participant; Pregnancy confirmed with beta-human chorionic gonadotropin (beta-HCG) serum or urine pregnancy test in WOCBP at screening.

-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:; Peripheral T-cell lymphoma not otherwise specified (PTCL, NOS); Angioimmunoblastic T-cell lymphoma (AITL); T-follicular helper (TFH) lymphoma; Anaplastic large cell lymphoma (ALCL); Enteropathy-associated T-cell lymphoma (EATL); Monomorphic epitheliotropic intestinal T-cell lymphoma (MEITL); Adult T-cell leukemia/lymphoma (ATLL); Other T-cell lymphoma (TCL); 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:; 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; 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; Participants who are hepatitis B core antibody (HBcAb) positive must have a hepatitis B virus (HBV) viral load result <100 IU/mL. Note: participants who are hepatitis B surface antigen (HBsAg) positive are excluded; Participants with detectable Epstein-Barr virus (EBV) or Cytomegalovirus (CMV) by polymerase chain reaction will be eligible provided they do not have end organ dysfunction from EBV or CMV infection; Participants with pulmonary disease such as chronic obstructive pulmonary disease and non-infectious liver disease who otherwise meet the requirements; Women of child-bearing potential (WOCBP) must agree to use effective methods of contraception (barrier, hormonal, surgical sterilization, abstinence) during the study treatment and for 6 months after the completion of the study treatment. Note: WOCBP is defined as any woman who has experienced menarche and who has not undergone successful surgical sterilization or who is not postmenopausal; Men able to father a child must agree to use an effective method of contraception (barrier, surgical sterilization, abstinence) during the study treatment and for 3 months after the completion of the study treatment. These men must not freeze or donate sperm within the same period; Nursing participants must be willing to discontinue nursing from study treatment initiation through six (6) months after the last dose of the study drug(s); Ability of the participant to understand and the willingness to sign a written informed consent document.

ClinicalTrials.gov NCT07388563