Haplo-cord Blood Transplant for AML and high-risk MDS

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This interventional study examines the use of haploidentical-cord blood hematopoietic stem cell transplantation in patients with AML and high-risk MDS. It aims to compare engraftment patterns—haploidentical engraftment versus cord blood engraftment—and their impact on hematopoietic recovery, immune tolerance, and long-term survival. The trial integrates conditioning regimens including fludarabine, cytarabine, busulfan, ATG, melphalan, and cyclophosphamide. It seeks to balance graft-versus-leukemia effects with GVHD risk and to provide evidence for optimizing transplantation strategies in this patient population.

Why it matters

Who can join: the full rules

Inclusion Criteria:

* Age between 14 and 60 years, with no gender restriction.
* Intermediate- or high-risk AML in first complete remission (CR1).
* AML in second or subsequent complete remission (≥ CR2).
* Relapsed or refractory AML.
* Low-risk AML meeting any of the following: Failure to achieve a ≥3-log reduction in RUNX1::RUNX1T1 transcript level compared with baseline after 2 consolidation cycles, or loss of major molecular remission (MMR) within 6 months; CBFB::MYH11/ABL ratio \> 0.1% at any time point after 2 consolidation cycles in patients with CBFB::MYH11-rearranged AML; Presence of D816 KIT mutation in patients with CBFB::MYH11-rearranged AML; Flow cytometry-positive MRD at any time point after 2 consolidation cycles in patients with CEBPA double-mutant AML; Persistently positive MRD after chemotherapy in patients with NPM1-mutated AML.
* Intermediate-2 or high-risk MDS according to the IPSS scoring system.
* Adequate general health status and ability to tolerate hematopoietic stem cell transplantation.
* Provision of signed informed consent and willingness to comply with study-required follow-up and examinations.

Exclusion Criteria:

* Prior history of other hematopoietic stem cell transplantation.
* History of ex vivo T-cell-depleted stem cell transplantation.
* Survival duration of less than 1 month after transplantation.
* Severe organ dysfunction, including significant impairment of hepatic, renal, cardiac, or pulmonary function.
* Active severe infection, such as uncontrolled pneumonia, sepsis, or other systemic infections.
* History of severe hypersensitivity reactions to study medications, including cyclophosphamide or anti-thymocyte globulin (ATG).
* Presence of severe psychiatric disorders or cognitive impairment that precludes compliance with study treatment and follow-up.
* Pregnant or lactating women.
* Concurrent malignancy of other organ system.
* Any other medical conditions deemed inappropriate for study participation by the treating investigators.

Where it's running

• Fujian Medical University Union Hospital
  Fuzhou, Fujian, China Recruiting
• Guangdong Provincial People's Hospital
  Guangzhou, Guangdong, China Not yet recruiting
• Sichuan Provincial People's Hospital
  Chengdu, Sichuan, China Not yet recruiting
• Chinese PLA General Hospital
  Beijing, China Not yet recruiting

Study contacts

• Study coordinator: Nainong Li, MD
• Email: nainli@aliyun.com
• Phone: +86 13365910189

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Other studies for the same condition or treatment. Recruiting studies are listed first.

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.