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Azacitidine Combined with Donor Lymphocyte Infusion for Acute Myeloid Leukemia Post-transplant Relapse Prevention.

NCT06754540 · Status: NOT_YET_RECRUITING · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 51

Last updated 2025-01-17

No results posted yet for this study

Summary

This study is single-center, single-arm, prospective, Phase II clinical trial with the primary objective of assessing the effectiveness of azacitidine combined with donor lymphocyte infusion (DLI) in the prevention of recurrence after high-risk haploid hematopoietic stem cells of AML.

At the screening/baseline period, informed consent is obtained and the inclusion/exclusion criteria are checked. Plan to enroll 51 patients, and collect demographic data, medical history data, vital signs, physical examination and laboratory tests (blood routine; urine routine; liver and kidney function;Immune indicators: T cell subsets, Treg, etc.), pregnancy tests for female patients and other necessary auxiliary inspections.The time to start treatment is from the +90 to +180 days after high-risk AML haploid hematopoietic stem cell transplantation.

Conditions

  • Acute Myeloid Leukemia (AML)
  • Relapse

Interventions

DRUG

Azacitidine (AZA)

Azacitidine 32mg/m2

Sponsors & Collaborators

  • Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine

    lead OTHER

Principal Investigators

  • Xianmin Song, M.D · Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine

Study Design

Allocation
NA
Purpose
PREVENTION
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
70 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-01-16
Primary Completion
2027-01-01
Completion
2027-01-01

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06754540 on ClinicalTrials.gov