๐ฌIn plain words
What the trial is, and whether it could suit you
This study aims to investigate the clinical efficacy of haploidentical-cord blood hematopoietic stem cell transplantation in patients with acute myeloid leukemia (AML) and high-risk myelodysplastic syndromes (MDS), and to analyze the impact of different engraftment patterns (haploidentical engraftment versus cord blood engraftment) on clinical outcomes. By comparing the efficacy of haploidentical-cord blood transplantation in different subtypes of AML and MDS, this research will explore its unique advantages and comparative effectiveness relative to conventional transplantation strategies, so as to provide new evidence for clinical practice.
Specific research objectives I. To evaluate the efficacy of haploidentical-cord blood hematopoietic stem cell transplantation for AML and high-risk MDS, including the speed of hematopoietic recovery, immune tolerance, and long-term survival rates.
Sign in to get the eligibility rules as simple questions to take to your doctor.
๐ Eligibility rules (as published)
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 (โฅ CR2).
* Relapsed or refractory AML.
* Low-risk AML meeting any of the following: Failure to achieve a โฅ3-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.