Combining microtransplantation and azacytidine for treating elderly acute myeloid leukemia

A Multicenter Clinical Study of Microtransplantation Combined With Azacytidine to Improve the Efficacy of Elderly Acute Myeloid Leukemia

This study is testing whether a new treatment combining microtransplantation and azacytidine can help older patients with acute myeloid leukemia achieve remission and live longer without the disease.

Quick facts

• Phase: NA
• Study type: Interventional
• Enrollment: 300 (estimated)
• Ages: 60 Years to 85 Years
• Sex: All
• Sponsor: The Affiliated Hospital of the Chinese Academy of Military Medical Sciences (other)
• Drugs / interventions: chemotherapy
• Locations: 1 site (Beijing, Beijing)
• Trial ID: NCT05262465 on ClinicalTrials.gov

What this trial studies

This study investigates the efficacy of microtransplantation combined with azacytidine in elderly patients with acute myeloid leukemia (AML). Patients will receive induction and consolidation chemotherapy alongside HLA-mismatched peripheral blood stem cell infusion. The study aims to observe remission rates and assess two-year disease-free survival and overall survival rates. Previous data from over 70 elderly AML patients indicated promising outcomes with this approach, which has been validated in multiple centers across different countries.

Who should consider this trial

Good fit: Ideal candidates are elderly patients aged 60-85 with newly diagnosed, pathologically confirmed AML.

Not a fit: Patients with acute promyelocytic leukemia, myeloid sarcoma, or those with active CNS disease may not benefit from this study.

Why it matters

Potential benefit: If successful, this treatment could significantly improve remission rates and survival outcomes for elderly patients with AML.

How similar studies have performed: Previous studies using microtransplantation in elderly AML patients have shown promising results, indicating that this approach has been clinically validated.

Eligibility criteria

Inclusion Criteria:

* Patients must have elderly (60-85 ages) AML pathologically confirmed per WHO guidelines.
* Patients have not been treated before.
* Patients must have ECOG Performance status of 0,1,or 2. If ECOG 2.
* Patients must have a HLA mismatched donor who should be able to provide informed consent.
* All genders and races are eligible.
* ALT and AST≤3 ×ULN, TBIL≤1.5 × ULN, Cr≤2 ×ULN or CrCl≥40 mL/min
* By means of ultrasonic Heartbeat map or multiple gated acquisition (MUGA) scanning determination of LVEF in the normal range.
* Donors must be able to safely undergo leukapheresis.

Exclusion Criteria:

* received operation 4 weeks before randomization
* acute promyelocytic leukemia,Myeloid sarcoma, chronic myeloid leukemia in accelerated phase and blastic phase;
* active CNS disease, pregnancy, or other major medical or psychiatric illnesses that could compromise tolerance to this protocol
* occurred stroke or intracranial hemorrhage within 6 months before randomization.
* Require the use of warfarin or equivalent of vitamin K antagonists (such as phenprocoumon) anticoagulant.
* There is clinical significance of cardiovascular disease, such as uncontrolled or symptomatic arrhythmias, congestive heart failure or myocardial infarction within 6 months before randomization, or any heart function grade 3 (moderate) or 4 (severe ) heart disease in accordance with the functional classification method of New York Heart Association (NYHA).
* Known to have the following history: human immunodeficiency virus (HIV) or active hepatitis C virus or hepatitis B virus infection
* Any situation processed by the PI that will be damaged to the patients safety.
* Patients and / or authorized family member refuse to sign the consent.
* attend other clinical researchers in 3 months.
* Donors exclusion criteria include:active infection or malignancy, cardiovascular instability, severe anemia, severe coagulation disorder, pregnancy, inadequate venous access, inability to provide consent, or any other condition deemed unsafe by the treatment staff.

Where this trial is running

Beijing, Beijing

• The fifth medical center of PLA General Hospital — Beijing, Beijing, China (RECRUITING)

Study contacts

• Study coordinator: yajing huang

Conditions: Adult Acute Myeloid Leukemia