Acute Leukemia, Chronic Myeloid Leukemia, Myelodysplastic Syndrome
Conditions
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.
Interventions
PROCEDUREHSCT from MSD
HSCT from MSD is the first choice for the patients who have HLA-matched sibling donors.
PROCEDUREHSCT from MUD
HSCT from MUD is the second choice for the patients who don't have HLA-matched sibling donors but have HLA-matched unrelated donors.
PROCEDUREHSCT from HRD
HSCT from HRD is the choice for the patients who have neither HLA-matched sibling donors nor HLA-matched unrelated donors.
DRUGCyclosporin A
CsA is used in all the patients for GVHD prophylaxis.
DRUGMethotrexate
MTX is used in all the patients for GVHD prophylaxis.
DRUGAntithymocyte globulin
ATG is used in the patients receiving HSCT from MUD and HRD for GVHD prophylaxis.In MUD group,total ATG doses is 7 mg/kg;In HRD group,total ATG doses is 7.5 or 10 mg/kg.
DRUGMycophenolate mofetil
MMF is used in the patients receiving HSCT from MSD and HRD for GVHD prophylaxis.
Sponsors
Guangdong Provincial People's Hospital
Third Affiliated Hospital, Sun Yat-Sen University
Guangzhou General Hospital of Guangzhou Military Command
Guangzhou First People's Hospital
Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University
Zhujiang Hospital
Tongji Hospital
Union Hospital, Tongji Medical College, Huazhong University of Science and Technology
Fujian Medical University Union Hospital
First Affiliated Hospital of Guangxi Medical University
Xiangya Hospital of Central South University
Nanfang Hospital, Southern Medical University
Study design
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 60 Years
Healthy volunteers
No
Inclusion criteria
* Diagnosis of primary disease is acute leukemia/MDS/CML * Receiving allo-HSCT
Exclusion criteria
* 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)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Overall Survival | 3 year | The primary endpoint is overall survival within 3 years after HSCT. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 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. |
| hematopoietic reconstruction | 1 year | Hematopoietic reconstruction includes the time of neutrophil and platelet reconstruction. |
Countries
China
Outcome results
None listed