NCT07388563 · National Cancer Institute (NCI)
Azacitidine and Abatacept in Relapsed or Refractory T-Cell Lymphoma
What this study is about
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.
View original scientific description
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....
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.
Primary outcome measures
Arm 2: To estimate the CRR of the combination of azacitidine and abatacept.
Time frame: 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.
Complete response rate (CRR) will be evaluated in Arm 2 in participants treated at MTD. CRR will be estimated along with a 95% confidence interval (CI).
Arm 1: To estimate the MTD of the combination of azacitidine and abatacept in relapsed or refractory T-cell lymphoma.
Time frame: 56 days (cycles 0-1)
MTD will be determined based on the DLT profile during the DLT window in Arm 1 56 days (cycles 0-1).
Who can participate
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
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.
Exclusion criteria
- Any second malignancy that requires current active systemic therapy.
- Latent tuberculosis (TB) infection.
- 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.
- Uncontrolled intercurrent illness, factors, evaluated by medical history, electrocardiogram (EKG), and physical exam that would potentially increase in risk of participant.
Where
- Bethesda, Maryland
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Frequently asked questions
What is a clinical trial?
A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.
Is it safe to participate?
Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.
Will I be compensated?
Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.
Will I receive a placebo instead of treatment?
When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.
Can I leave a trial if I change my mind?
Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.
How long does a clinical trial last?
Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.
Data: ClinicalTrials.gov · synced Oct 9, 2026 · Source of record for eligibility and locations