Allogeneic Stem Cell Transplantation With Alternative Donor in Treatment of Hematologic Malignancy
Overview
- Phase
- Not Applicable
- Intervention
- HSCT from MSD
- Conditions
- Acute Leukemia
- Sponsor
- Nanfang Hospital, Southern Medical University
- Enrollment
- 876
- Locations
- 1
- Primary Endpoint
- Overall Survival
- Status
- Completed
- Last Updated
- 6 years ago
Overview
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.
Investigators
Qifa Liu
Professor
Nanfang Hospital, Southern Medical University
Eligibility Criteria
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)
Arms & Interventions
MSD group
The patients will received HSCT from MSD.
Intervention: HSCT from MSD
MSD group
The patients will received HSCT from MSD.
Intervention: Cyclosporin A
MSD group
The patients will received HSCT from MSD.
Intervention: Methotrexate
MSD group
The patients will received HSCT from MSD.
Intervention: Mycophenolate mofetil
MUD group
The patients will received HSCT from MUD.
Intervention: HSCT from MUD
MUD group
The patients will received HSCT from MUD.
Intervention: Cyclosporin A
MUD group
The patients will received HSCT from MUD.
Intervention: Methotrexate
MUD group
The patients will received HSCT from MUD.
Intervention: Antithymocyte globulin
HRD group
The patients will received HSCT from HRD.
Intervention: HSCT from HRD
HRD group
The patients will received HSCT from HRD.
Intervention: Cyclosporin A
HRD group
The patients will received HSCT from HRD.
Intervention: Methotrexate
HRD group
The patients will received HSCT from HRD.
Intervention: Antithymocyte globulin
HRD group
The patients will received HSCT from HRD.
Intervention: Mycophenolate mofetil
Outcomes
Primary Outcomes
Overall Survival
Time Frame: 3 year
The primary endpoint is overall survival within 3 years after HSCT.
Secondary Outcomes
- hematopoietic reconstruction(1 year)
- Disease-free survival(3 year)
- Incidence of transplantation-related mortality(3 year)
- Incidence of graft-versus-host disease(3 year)
- Incidence of infection(3 year)