NCT06754540

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

• Status: Not Yet Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 51 (estimated)
• Sponsor: Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine · Academic / Other
• Sex: All
• Age: 18 Years – 70 Years
• Healthy volunteers: Not accepted

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.

Detailed description

1.Basic solution: 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. 1. Start time of medication: +90 \~ +120 days after transplantation. 2. Donor lymphocyte infusion was preceded by anti-anaphylaxis,such as promethazine and hormone therapy was prohibited. 3. In the course of AZA and DLI intervention, other targeted drugs such as venetoclax or chemotherapy drugs can be added on the basis of AZA if MRD or MRD increase (\>1log) ,DLI continues as planned. 2.Stop treatment: Occurrence of any of the following conditions: 1. Life-threatening complications. 2. Acute GVHD above II degree; chronic GVHD above moderate manifestations or overlapping syndrome; No chronic GVHD is observed if acute GVHD remission is observed after discontinuation for 1 to 2 months, then preventive treatment is started again . 3. Hematologic recurrence, graft rejection or bone marrow donor chimerism \<90%.

Conditions

• Acute Myeloid Leukemia (AML)
• Relapse

Interventions

Type	Name	Description
DRUG	Azacitidine (AZA)	Azacitidine 32mg/m2

Timeline

• Start date: 2025-01-16
• Primary completion: 2027-01-01
• Completion: 2027-01-01
• First posted: 2025-01-01
• Last updated: 2025-01-17