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

NCT06754540 | Not Yet Recruiting Phase 2 DMC

• 1 other identifier: SHSYXY-202405-AZA-DLI
• Study Type: interventional
• Target: 51
• Locations: 0 countries
• Sites: N/A

Brief 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

Keywords

azacitidine; donor lymphocyte infusion; HSCT; haploid; high-risk; AML

Outcome Measures

Primary Outcomes (1)

• Leukemia-free survival (LFS) time

  Summary statistics for LFS time will be computed for all patients.

  From the date of transplantation, assessed up to 1 year after transplantation.

Secondary Outcomes (5)

• overall survival (OS)

  From the date of transplantation, assessed up to 1 year after transplantation.

• Cumulative incidence of relapse (CIR)

  From the date of transplantation, assessed up to 1 year after transplantation.

• Cumulative incidence of acute and chronic GVHD

  From the date of transplantation, assessed up to 1 year after transplantation.

• NRM

  NRM

• Incidence of toxicity of the regimen

  From the date of transplantation, assessed up to 1 year after transplantation.

Study Arms (1)

AZA-DLI for acute myeloid leukemia post-transplant relapse preventiont

EXPERIMENTAL

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

Drug: Azacitidine (AZA)

Interventions

Azacitidine (AZA) DRUG

Azacitidine 32mg/m2

AZA-DLI for acute myeloid leukemia post-transplant relapse preventiont

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients enrolled must meet the following criteria:
• ≥18 years old and ≤70 years old, male or female;
• Patients with haploid peripheral blood stem cell transplantation of AML;
• All patients received BU based myeloablative conditionings;
• 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) .
• Blood routine: neutrophils ≥1×10\^9/L, platelet ≥50.0×10\^9/L;
• There is no active grade II or higher acute GVHD or moderate or severe chronic GVHD;
• The ECOG score is 0 to 2;
• Donor lymphocytes are available;
• The patient must be able to understand and be willing to participate in the study and sign an informed consent form.

You may not qualify if:

• Possible subjects who meet any of the following criteria will be excluded from the trial:
• Those who are allergic to known azacitidine or interferon
• Patients with active acute GVHD;
• Patients with moderate or more chronic GVHD;
• Non-haploid donor transplants;
• Patients who have not achieved complete remission after transplantation;
• 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%;
• Patient blood routine: ANC\<1.0×10\^9/L or PLT\<50×10\^9/L;
• 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;
• Patient with severe active infection;
• Pregnant or lactating women;
• Have received other interventions or are receiving other research drugs before the study begins;
• At the discretion of the investigator, other dangerous complications may result.

Sponsors & Collaborators

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

MeSH Terms

Conditions

Leukemia, Myeloid, Acute; Recurrence

Interventions

Azacitidine

Condition Hierarchy (Ancestors)

Leukemia, Myeloid; Leukemia; Neoplasms by Histologic Type; Neoplasms; Hematologic Diseases; Hemic and Lymphatic Diseases; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Aza Compounds; Organic Chemicals; Cytidine; Pyrimidine Nucleosides; Pyrimidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Nucleosides; Nucleic Acids, Nucleotides, and Nucleosides; Ribonucleosides

Study Officials

• Xianmin Song, M.D

  Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Xianmin Song, M.D

CONTACT

021-63240090; shongxm@139.com

Ying zhang, doctor

CONTACT

021-37798987; zhangyingm03@163.com

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: director

Study Record Dates

• First Submitted: December 29, 2024
• First Posted: January 1, 2025
• Study Start: January 16, 2025
• Primary Completion (Estimated): January 1, 2027
• Study Completion (Estimated): January 1, 2027
• Last Updated: January 17, 2025

Record last verified: 2025-01

Data Sharing

• IPD Sharing: Will not share