Relapsed/Refractory High-Risk Acute Leukemia
Conditions
Interventions
Test group:The addition of ruxolitinib, decitabine, and venetoclax to the classic Bu/Cy preconditioning regimen.
Sponsors
Chinese PLA General Hospital
Eligibility
Sex/Gender
All
Age
12 Years to 75 Years
Inclusion criteria
Inclusion criteria: 1. Patients with an indication for allogeneic hematopoietic stem cell transplantation, including high-risk acute leukemia, myelodysplastic syndrome (MDS), chronic myelomonocytic leukemia (CMML), and myeloproliferative neoplasms (MPNs), in second complete remission (CR2) or non-remission (NR) status. 2. Availability of an HLA-matched sibling donor, haploidentical donor, or unrelated donor with >=8/10 HLA compatibility. 3. Age between 12 and 75 years. 4. Hepatic function: Alanine aminotransferase (ALT) and aspartate aminotransferase (AST) <=2.5×upper limit of normal (ULN); total bilirubin <=2×ULN. 5. Renal function: Serum creatinine =ULN. 6. Absence of uncontrolled infections or severe psychiatric/psychological disorders. 7. Eastern Cooperative Oncology Group (ECOG) performance status 0-2. 8. Provision of signed informed consent.
Exclusion criteria
Exclusion criteria: 1. Pregnancy in either the donor or recipient. 2. Presence of psychiatric disorders or other conditions precluding protocol compliance. 3. Diagnosis of acute promyelocytic leukemia (APL).
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 1-year GVHD-free and relapse-free survival (GFRFS) ; | — |
Secondary
| Measure | Time frame |
|---|---|
| Complete response rate (CR);Incidence of acute GVHD (aGVHD);1-year overall survival (OS);Cumulative incidence of non-relapse mortality (NRM);Incidence of chronic GVHD (cGVHD);Cumulative incidence of relapse (CIR);Treatment-related safety metrics; | — |
Countries
China
Contacts
Public ContactDaihong Liu
Chinese PLA General Hospital
Outcome results
None listed