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

Launched by SHANGHAI GENERAL HOSPITAL, SHANGHAI JIAO TONG UNIVERSITY SCHOOL OF MEDICINE · Dec 30, 2024

Keywords

ClinConnect Summary

This clinical trial is studying a new treatment approach for patients with acute myeloid leukemia (AML) who are at high risk of their cancer coming back after undergoing a specific type of stem cell transplant. The researchers want to see if combining a medication called azacitidine with donor lymphocyte infusion (DLI) can help prevent the recurrence of AML after transplant. The trial will include 51 participants, and treatment will start between 90 to 180 days after their transplant.

To be eligible for this trial, participants must be between 18 and 70 years old, have undergone haploid peripheral blood stem cell transplantation for AML, and have certain blood counts that meet the study's requirements. They should not have any severe complications from the transplant, such as active graft-versus-host disease (GVHD), which is when the donor's immune cells attack the recipient's body. Participants will undergo various tests to ensure they are suitable for the study. The trial is currently not recruiting, but it offers an opportunity for eligible patients to potentially benefit from a new treatment strategy aimed at preventing AML relapse.

Gender

ALL

Eligibility criteria

• 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.