Allo-HSCT With Alternative Donor in Treatment of Hematologic Malignancy
- Conditions
- Chronic Myeloid LeukemiaAcute LeukemiaMyelodysplastic Syndrome
- Interventions
- Procedure: HSCT from MSDProcedure: HSCT from MUDProcedure: HSCT from HRDDrug: Antithymocyte globulin
- Registration Number
- NCT02487069
- Lead Sponsor
- Nanfang Hospital, Southern Medical University
- Brief Summary
The purpose of this study is to compare the efficacy of allogeneic hematopoietic stem cell transplantation (allo-HSCT) from matched sibling donor (MSD),matched unrelated donor (MUD) and haploidentical related donors(HRD) in the treatment of hematologic malignancy.
- Detailed Description
Currently, allogeneic hematopoietic stem cell transplantation (allo-HSCT) remains the only curative therapy for a majority of malignant hematologic diseases, especially acute leukemia. HSCT from MSD offers the best results for these diseases, but lack of this donor resource has restricted its wide application. HSCT from MUD provides another option, but MUDs still cannot satisfy all patients due to unsuccessful donor searches. Almost all patients have an available related donor with whom they share a single HLA haplotype (ie, haploidentical related donor), and it owns the advantage of immediate availability, especially for those who urgently need transplantation.The results of transplantation from HRD have improved significantly over the past few years. However, the results from such haploidentical transplantation have not formally been compared with those of transplantation in patients contemporaneously using MSDs and MUDs for hematologic malignancy.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 876
- Diagnosis of primary disease is acute leukemia/MDS/CML
- Receiving allo-HSCT
- cardiac dysfunction (particularly congestive heart failure)
- hepatic abnormalities (bilirubin ≥ 3 mg/dL, aminotransferase> 2 times the upper limit of normal)
- renal dysfunction (creatinine clearance rate < 30 mL/min)
- Any abnormality in a vital sign (e.g., heart rate, respiratory rate, or blood pressure)
- Patients with any conditions not suitable for the trial (investigators' decision)
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description MSD group HSCT from MSD The patients will received HSCT from MSD. MUD group HSCT from MUD The patients will received HSCT from MUD. HRD group Antithymocyte globulin The patients will received HSCT from HRD. MUD group Antithymocyte globulin The patients will received HSCT from MUD. HRD group HSCT from HRD The patients will received HSCT from HRD. MSD group Methotrexate The patients will received HSCT from MSD. MSD group Mycophenolate mofetil The patients will received HSCT from MSD. MSD group Cyclosporin A The patients will received HSCT from MSD. MUD group Cyclosporin A The patients will received HSCT from MUD. MUD group Methotrexate The patients will received HSCT from MUD. HRD group Methotrexate The patients will received HSCT from HRD. HRD group Cyclosporin A The patients will received HSCT from HRD. HRD group Mycophenolate mofetil The patients will received HSCT from HRD.
- Primary Outcome Measures
Name Time Method Overall Survival 3 year The primary endpoint is overall survival within 3 years after HSCT.
- Secondary Outcome Measures
Name Time Method hematopoietic reconstruction 1 year Hematopoietic reconstruction includes the time of neutrophil and platelet reconstruction.
Disease-free survival 3 year Incidence of transplantation-related mortality 3 year Incidence of graft-versus-host disease 3 year Graft-versus-host disease include acute and chronic Graft-versus-host disease
Incidence of infection 3 year Infection includes bacterial, fungal and viral infections.
Trial Locations
- Locations (1)
Department of Hematology,Nanfang Hospital, Southern Medical University
🇨🇳Guangzhou, Guangdong, China