Allo-HSCT With Alternative Donor in Treatment of Hematologic Malignancy

Study Overview
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Brief Summary
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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
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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.

Official Title
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Allogeneic Stem Cell Transplantation With Alternative Donor in Treatment of Hematologic Malignancy

Conditions
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Myelodysplastic Syndrome, Acute Leukemia, Chronic Myeloid Leukemia

Intervention / Treatment
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* Procedure: HSCT from MSD
* Procedure: HSCT from MUD
* Procedure: HSCT from HRD
* Drug: Cyclosporin A
* Drug: Methotrexate
* Drug: Antithymocyte globulin
* Drug: Mycophenolate mofetil


Participation Criteria
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Eligibility Criteria
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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)

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 60 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: MSD group<br>The patients will received HSCT from MSD. | Procedure: HSCT from MSD<br>* HSCT from MSD is the first choice for the patients who have HLA-matched sibling donors.<br>Drug: Cyclosporin A<br>* CsA is used in all the patients for GVHD prophylaxis.<br>* Other names: CsA;Drug: Methotrexate<br>* MTX is used in all the patients for GVHD prophylaxis.<br>* Other names: MTX;Drug: Mycophenolate mofetil<br>* MMF is used in the patients receiving HSCT from MSD and HRD for GVHD prophylaxis.<br>* Other names: MMF;|
| Experimental: MUD group<br>The patients will received HSCT from MUD. | Procedure: HSCT from MUD<br>* HSCT from MUD is the second choice for the patients who don't have HLA-matched sibling donors but have HLA-matched unrelated donors.<br>Drug: Cyclosporin A<br>* CsA is used in all the patients for GVHD prophylaxis.<br>* Other names: CsA;Drug: Methotrexate<br>* MTX is used in all the patients for GVHD prophylaxis.<br>* Other names: MTX;Drug: Antithymocyte globulin<br>* 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.<br>* Other names: ATG;|
| Experimental: HRD group<br>The patients will received HSCT from HRD. | Procedure: HSCT from HRD<br>* HSCT from HRD is the choice for the patients who have neither HLA-matched sibling donors nor HLA-matched unrelated donors.<br>Drug: Cyclosporin A<br>* CsA is used in all the patients for GVHD prophylaxis.<br>* Other names: CsA;Drug: Methotrexate<br>* MTX is used in all the patients for GVHD prophylaxis.<br>* Other names: MTX;Drug: Antithymocyte globulin<br>* 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.<br>* Other names: ATG;Drug: Mycophenolate mofetil<br>* MMF is used in the patients receiving HSCT from MSD and HRD for GVHD prophylaxis.<br>* Other names: MMF;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Overall Survival | The primary endpoint is overall survival within 3 years after HSCT. | 3 year | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Disease-free survival |  | 3 year | 
| Incidence of transplantation-related mortality |  | 3 year | 
| Incidence of graft-versus-host disease | Graft-versus-host disease include acute and chronic Graft-versus-host disease | 3 year | 
| Incidence of infection | Infection includes bacterial, fungal and viral infections. | 3 year | 
| hematopoietic reconstruction | Hematopoietic reconstruction includes the time of neutrophil and platelet reconstruction. | 1 year |