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NCT07388563
Azacitidine and Abatacept in Relapsed or Refractory T-Cell Lymphoma
Conditions: Lymphoma, T Cell, Peripheral, T-cell Lymphoma, Angioimmunoblastic T-cell Lymphoma, Anaplastic Large Cell Lymphoma, Monomorphic Epitheliotropic Intestinal T-cell Lymphoma, Adult T-cell Leukemia/Lymphoma
Sex: All
Ages: 18 Years – 120 Years
Healthy volunteers: No
Phase: PHASE1
Enrollment: 20
Sponsor: National Cancer Institute (NCI)
Location: National Institutes of Health Clinical Center Bethesda Maryland
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....
Eligibility Criteria
-INCLUSION CRITERIA
1. 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)
2. Participants must have a disease that is relapsed or refractory after initial systemic treatment.
3. Participants must have evaluable disease on screening imaging or by laboratory assessment.
4. Age \>= 18 years.
5. ECOG performance status \= 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 \= 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 / \
Source: ClinicalTrials.gov (NCT07388563). StuddyBuddy aggregates publicly available trial information.