NCT07388563

Brief 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....

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
20

participants targeted

Target at P25-P50 for phase_1

Timeline
21mo left

Started Mar 2026

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress7%
Mar 2026Dec 2027

First Submitted

Initial submission to the registry

February 4, 2026

Completed
1 day until next milestone

First Posted

Study publicly available on registry

February 5, 2026

Completed
2 months until next milestone

Study Start

First participant enrolled

March 26, 2026

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 31, 2027

Expected
9 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2027

Last Updated

March 31, 2026

Status Verified

March 17, 2026

Enrollment Period

1 year

First QC Date

February 4, 2026

Last Update Submit

March 28, 2026

Conditions

Monomorphic Epitheliotropic Intestinal T-cell LymphomaLymphoma, T Cell, PeripheralAngioimmunoblastic T-cell LymphomaAnaplastic Large Cell LymphomaAdult T-cell Leukemia/LymphomaT-cell Lymphoma

Keywords

Selective Costimulation ModulatorsImmunomodulatorsBiological TherapyChemotherapy

Outcome Measures

Primary Outcomes (2)

  • Arm 2: To estimate the CRR of the combination of azacitidine and abatacept.

    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).

    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.

  • Arm 1: To estimate the MTD of the combination of azacitidine and abatacept in relapsed or refractory T-cell lymphoma.

    MTD will be determined based on the DLT profile during the DLT window in Arm 1 56 days (cycles 0-1).

    56 days (cycles 0-1)

Secondary Outcomes (2)

  • To determine the ORR defined as CR + PR to the combination of azacitidine and abatacept

    Day 1 of every cycle then at the EOT/PD visit, every 3 months for years 1-2, every 6 months for years 3-4, then once a year until progression, initiation of another line of therapy, or 5 years since treatment initiation.

  • To determine the safety profile of a combination of azacitidine and abatacept in relapsed or refractory T-cell lymphoma

    Day 1 through 30 days after the last study intervention was administered or before the initiation of a new anti-cancer treatment, whichever comes first.

Study Arms (2)

Arm 1

EXPERIMENTAL

Escalating/de-escalating doses of azacitidine + abatacept

Drug: azacitidineDrug: abatacept

Arm 2

EXPERIMENTAL

MTD of azacitidine + abatacept if less than 12 participants are enrolled in Arm 1

Drug: azacitidineDrug: abatacept

Interventions

azacitidineDRUG

Days 1-5 or 1-7 of every cycle (12 cycles): azacitidine subcutaneous or IV at the dose of 75 mg/m2

Arm 1Arm 2
abataceptDRUG

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.

Arm 1Arm 2

Eligibility Criteria

Age18 Years - 120 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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
  • +20 more criteria

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

National Institutes of Health Clinical Center

Bethesda, Maryland, 20892, United States

RECRUITING

Related Links

MeSH Terms

Conditions

Lymphoma, T-Cell, PeripheralLymphoma, T-CellImmunoblastic LymphadenopathyLymphoma, Large-Cell, AnaplasticPrecursor T-Cell Lymphoblastic Leukemia-Lymphoma

Interventions

AzacitidineAbatacept

Condition Hierarchy (Ancestors)

Lymphoma, Non-HodgkinLymphomaNeoplasms by Histologic TypeNeoplasmsLymphoproliferative DisordersLymphatic DiseasesHemic and Lymphatic DiseasesImmunoproliferative DisordersImmune System DiseasesLymphadenopathyPrecursor Cell Lymphoblastic Leukemia-LymphomaLeukemia, LymphoidLeukemiaHematologic Diseases

Intervention Hierarchy (Ancestors)

Aza CompoundsOrganic ChemicalsCytidinePyrimidine NucleosidesPyrimidinesHeterocyclic Compounds, 1-RingHeterocyclic CompoundsNucleosidesNucleic Acids, Nucleotides, and NucleosidesRibonucleosidesImmunoconjugatesAntibodiesImmunoglobulinsSerum GlobulinsBlood ProteinsProteinsAmino Acids, Peptides, and ProteinsGlobulins

Study Officials

  • Max J Gordon, M.D.

    National Cancer Institute (NCI)

    PRINCIPAL INVESTIGATOR

Central Study Contacts

National Cancer Institute Referral Offic

CONTACT

(888) 624-1937ncimo_referrals@mail.nih.gov

Max J Gordon, M.D.

CONTACT

(240) 858-7151max.gordon@nih.gov

Study Design

Study Type
interventional
Phase
phase 1
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
SEQUENTIAL
Sponsor Type
NIH
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 4, 2026

First Posted

February 5, 2026

Study Start

March 26, 2026

Primary Completion (Estimated)

March 31, 2027

Study Completion (Estimated)

December 31, 2027

Last Updated

March 31, 2026

Record last verified: 2026-03-17

Data Sharing

IPD Sharing
Will share

This study will comply with the NIH Data Management and Sharing (DMS) Policy, which applies to all new and ongoing NIH-funded research in the IRP, as of January 25, 2023, that is associated with a ZIA, with a clinical protocol that undergoes scientific review and/or will involve genomic data sharing.

Shared Documents
STUDY PROTOCOL, SAP, ICF
Time Frame
Data will be made available as soon as possible or at the time of associated publication. Data not published in a manuscript will be shared via public source once the data set completes QC.
Access Criteria
Clinical data will be made available upon request and with the permission of the study PI. Genomic data are made available via dbGAP through requests to the data custodians.

Locations

US(1)