Acute Myeloid Leukemia, Myelodysplastic Syndromes
Conditions
Interventions
Umbilical cord blood transplant group:Umbilical Cord Blood Transplantation with Reduced-Dose VMAT-TBI Combined with Dual Alkylating Agents as the Conditioning Regimen
Sponsors
Army Medical Center of PLA
Eligibility
Sex/Gender
All
Age
18 Years to 70 Years
Inclusion criteria
Inclusion criteria: According to the 2025 Chinese Society of Clinical Oncology (CSCO) guidelines for hematopoietic stem cell transplantation in hematological diseases, adult AML and MDS patients with transplantation indications. 1. Aged 18-70 years, either gender. 2. Inclusion criteria for AML (non-APL): AML in CR1 with intermediate- or high-risk, AML in CR2 or beyond, relapsed/refractory AML, myelodysplasia-related AML (AML-MR), AML with prior MDS/CMML, or therapy-related acute myeloid leukemia (t-AML). For low-risk AML: (1) RUNX1::RUNX1T1 transcript level decline 0.1% at any time after 2 courses of consolidation; (3) AML with CBFB::MYH11 accompanied by D816KIT mutation; (4) AML with biallelic CEBPA mutations, with MRD positivity by flow cytometry at any time after 2 courses of consolidation; (5) AML with NPM1 mutation with persistent MRD positivity after chemotherapy. 3. Inclusion criteria for MDS: (1) Higher-risk MDS patients, including those with IPSS score >1 (intermediate-2 and high-risk groups), IPSS-R score >3.5 (intermediate, high, and very high-risk groups), or IPSS-M high-risk/very high-risk groups. (2) Lower-risk patients with severe cytopenia, ineffective response to other therapies, or adverse prognostic genetic abnormalities. 4. Good general health status with ability to tolerate stem cell transplantation. 5. Signed informed consent and willingness to comply with follow-up and examinations as required by the study.
Exclusion criteria
Exclusion criteria: 1. Prior receipt of any other hematopoietic stem cell transplantation; 2. Recipients of ex vivo T-cell-depleted stem cell grafts; 3. Overall survival less than 1 month after previous transplantation; 4. Severe organ dysfunction (e.g., severe impairment of liver, renal, cardiac or pulmonary function); 5. Uncontrolled active severe infections, such as untreated pneumonia, sepsis, etc.; 6. Presence of severe psychiatric disorders or cognitive dysfunction that prevents cooperation with study treatment and follow-up; 7. Pregnant or breastfeeding women; 8. Concurrent malignancies of other organ systems; 9. Any other medical conditions judged by the study physician to render the patient ineligible for participation.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Transplant-related mortality at +100 days; | — |
Secondary
| Measure | Time frame |
|---|---|
| Neutrophil engraftment rate at +42 days;Platelet engraftment rate at +180 days;Incidence of grades I–IV acute graft-versus-host disease;Incidence of grades III–IV acute graft-versus-host disease;Incidence of severe infections within 100 days post-transplant;Disease-free survival rate at 100 days post-transplant;Relapse rate;Explore the immune reconstitution after umbilical cord blood transplantation; | — |
Countries
China
Contacts
Public ContactZeng Dongfeng
Army Medical Center of PLA
Outcome results
None listed