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Azacitidine and Abatacept in Relapsed or Refractory T-Cell Lymphoma

StatusRecruiting
PhasePhase 1
Started
View on ClinicalTrials.gov ↗

Record History

  1. Minor Re-verified, no change to tracked fields
  2. Notable Recruitment resumed after suspension Eligibility criteria expanded, about 12 words · Secondary endpoints: details revised at 1 of 2 entries · Study description expanded, about 14 words · 1 more Show 4 more changesShow less
    • Eligibility criteria expanded, about 12 words
    • Secondary endpoints: details revised at 1 of 2 entries
    • Study description expanded, about 14 words
    • Site details revised
  3. Minor 3 versions Re-verified since Jul 3, 2026, no change to tracked fieldsv33-v35
  4. Stopped Recruitment suspended Sponsor's reason: New recruitment on hold for a protocol design amendment/modification. Site details revisedv32 Show 1 more changeShow less
    • Site details revised
  5. Minor Start date changed from estimate of Apr 2, 2026 to Mar 26, 2026v31
Show 29 earlier versionsHide 29 earlier versions
  1. Minor Start date: Apr 1, 2026 to Apr 2, 2026v30
  2. Minor Start date: Mar 31, 2026 to Apr 1, 2026v29
  3. Minor Start date: Mar 30, 2026 to Mar 31, 2026v28
  4. Minor Start date: Mar 29, 2026 to Mar 30, 2026v27
  5. Minor Start date: Mar 26, 2026 to Mar 29, 2026v26
  6. Minor Start date: Mar 25, 2026 to Mar 26, 2026v25
  7. Notable Trial status: Not Yet Recruiting to Recruiting Start date: Mar 23, 2026 to Mar 25, 2026 · Site details revisedv24 Show 2 more changesShow less
    • Start date: Mar 23, 2026 to Mar 25, 2026
    • Site details revised
  8. Minor Start date: Mar 22, 2026 to Mar 23, 2026v23
  9. Minor Start date: Mar 19, 2026 to Mar 22, 2026v22
  10. Minor Start date: Mar 18, 2026 to Mar 19, 2026v21
  11. Minor Start date: Mar 17, 2026 to Mar 18, 2026v20
  12. Minor Start date: Mar 16, 2026 to Mar 17, 2026v19
  13. Minor Start date: Mar 15, 2026 to Mar 16, 2026v18
  14. Minor Start date: Mar 12, 2026 to Mar 15, 2026v17
  15. Minor Start date: Mar 11, 2026 to Mar 12, 2026v16
  16. Minor Start date: Mar 10, 2026 to Mar 11, 2026v15
  17. Minor Start date: Mar 9, 2026 to Mar 10, 2026v14
  18. Minor Start date: Mar 8, 2026 to Mar 9, 2026v13
  19. Minor Start date: Mar 5, 2026 to Mar 8, 2026v12
  20. Minor Start date: Mar 4, 2026 to Mar 5, 2026v11
  21. Minor Start date: Mar 3, 2026 to Mar 4, 2026v10
  22. Minor Start date: Mar 2, 2026 to Mar 3, 2026v9
  23. Minor Start date: Mar 1, 2026 to Mar 2, 2026v8
  24. Minor Start date: Feb 26, 2026 to Mar 1, 2026v7
  25. Minor Start date: Feb 25, 2026 to Feb 26, 2026v6
  26. Minor Start date: Feb 24, 2026 to Feb 25, 2026v5
  27. Minor Start date: Feb 23, 2026 to Feb 24, 2026v4
  28. Minor Start date: Feb 22, 2026 to Feb 23, 2026v3
  29. Minor Start date: Feb 9, 2026 to Feb 22, 2026v2
  1. Minor Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
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 Details
NCT Number NCT07388563
Lead Sponsor National Cancer Institute (NCI)
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
Enrollment 20 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov