Clinical trial · Interventional
Azacitidine Combined with Donor Lymphocyte Infusion for Acute Myeloid Leukemia Post-transplant Relapse Prevention.
Efficacy and Safety of Azacitidine Combined with Donor Lymphocyte Infusion for Prevention of Recurrence After Haploid Hematopoietic Stem Cell Transplantation in High-risk Acute Myeloid Leukemia
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Acute Myeloid Leukemia (AML) | Acute Myeloid Leukemia | CURATED_BROADER | 0.80 |
| Relapse | — | UNRESOLVED | — |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Azacitidine (AZA) | Drug | Azacitidine | ALIAS |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- AZA-DLI for acute myeloid leukemia post-transplant relapse preventiont
- description
- One arm,Azacitidine is administered subcutaneously at 32 mg/m2/d for five consecutive days, starting no earlier than day +90 after HSCT, then repeated every 28 days for a total of twelve cycles. DLI is administered after an interval of 48 hours. Prophylactic DLI is given in escalating doses every four to six weeks for a total of three to four doses.The initial dose of DLI for haploid transplant patients is 1×10\^5 CD3+/kg receptor weight lymphocytes gradually increased to 5×10\^5, 1×10\^6 and (2\~5)×10\^6 CD3+ Lymphocytes
- interventionNames
- Drug: Azacitidine (AZA)
Primary outcomes (1)
- measure
- Leukemia-free survival (LFS) time
- timeFrame
- From the date of transplantation, assessed up to 1 year after transplantation.
- description
- Summary statistics for LFS time will be computed for all patients.
Secondary outcomes (5)
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 70 Years
Show eligibility criteria text
Inclusion Criteria: \- Patients enrolled must meet the following criteria: 1. ≥18 years old and ≤70 years old, male or female; 2. Patients with haploid peripheral blood stem cell transplantation of AML; 3. All patients received BU based myeloablative conditionings; 4. A diagnosis of high-risk AML is one of the following: ① Patients without morphologic CR before transplantation, including patients with initial refractory disease and recurrence. ② AML with poor prognosis (Standardized diagnosis and prognostic stratification of acute myeloid leukemia based on ELN edition which was 2022 Year) . 5. Blood routine: neutrophils ≥1×10\^9/L, platelet ≥50.0×10\^9/L; 6. There is no active grade II or higher acute GVHD or moderate or severe chronic GVHD; 7. The ECOG score is 0 to 2; 8. Donor lymphocytes are available; 9. The patient must be able to understand and be willing to participate in the study and sign an informed consent form. Exclusion Criteria: * Possible subjects who meet any of the following criteria will be excluded from the trial: 1. Those who are allergic to known azacitidine or interferon 2. Patients with active acute GVHD; 3. Patients with moderate or more chronic GVHD; 4. Non-haploid donor transplants; 5. Patients who have not achieved complete remission after transplantation; 6. AML recurrence after transplantation (bone marrow, peripheral blood primitive cells ≥5% or extramedullary recurrence), or graft rejection, bone marrow donor cell chimeric rate (STR) \<90%; 7. Patient blood routine: ANC\<1.0×10\^9/L or PLT\<50×10\^9/L; 8. Combined with severe organ dysfunction:liver function (AST/ALT) \>3 times normal upper limit; the direct bilirubin \> 3 times normal upper limit; renal function (Cr) \< 50mL/min or \>1.5 times normal upper limit, regardless of hemodialysis treatment; 9. Patient with severe active infection; 10. Pregnant or lactating women; 11. Have received other interventions or are receiving other research drugs before the study begins; 12. At the discretion of the investigator, other dangerous complications may result.
References
Publications (0)
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