Effect of Chemotherapy vs No Chemotherapy Pre-transplant to MDS Undergoing Allo-HSCT

Study Overview
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Brief Summary
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Allogeneic hematopoietic stem cell transplantation (allo-HSCT) appears to be an efficient tool to cure refractory anemia with excess blasts-1 (RAEB-1), refractory anemia with excess blasts-2 (RAEB-2) and acute myeloid leukemia (AML) secondary to myelodysplastic syndrome (MDS). At present, the necessity of chemotherapy pre-transplantation for RAEB-1, RAEB-2 and AML secondary to MDS (bone marrow blast cells less than 50%) undergoing allo-HSCT remains in discussion. In this study, the effects of chemotherapy and no chemotherapy pre-transplantation in patients with RAEB-1, REAB-2 and AML secondary to MDS (bone marrow blast cells less than 50%) undergoing allo-HSCT are evaluated.

Detailed Description
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Allo-HSCT appears to be an efficient tool to cure patients with MDS and AML secondary to MDS. Decitabine and/or chemotherapy pre-transplantation could reduce the blast cells in bone marrow and improve the complete remission rate. However, decitabine and/or chemotherapy had side effects and might increase treatment-related mortality. At present, the necessity of chemotherapy pre-transplantation for RAEB-1, RAEB-2 and AML secondary to MDS (bone marrow blast cells less than 50%) undergoing allo-HSCT remains in discussion. In this study, the effects of chemotherapy and no chemotherapy pre-transplantation in patients with RAEB-1, REAB-2 and AML secondary to MDS (bone marrow blast cells less than 50%) undergoing allo-HSCT are evaluated.

Official Title
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Effect of Chemotherapy vs No Chemotherapy Pre-transplantation for Patients With RAEB-1, RAEB-2 and AML Secondary to MDS (Bone Marrow Blast Cells Less Than 50%) Undergoing Allogeneic Hematopoietic Stem Cell Transplantation

Conditions
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Myelodysplastic Syndrome, Chemotherapy

Intervention / Treatment
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* Drug: Demethylation drug
* Drug: Chemotherapy regimen


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: RAEB-1, REAB-2 and AML Secondary to MDS (Bone marrow blast cells less than 50%) undergoing allo-HSCT 14-65 years Exclusion Criteria: 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: 14 Years
Maximum Age: 65 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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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Therapy pre-transplantation<br>Chemotherapy regimen and/or demethylation drugs(such as decitabine) were given pre-transplantation for patients with RAEB-1, REAB-2 and AML Secondary to MDS (bone marrow blast cells less than 50%). | Drug: Demethylation drug<br>* Demethylation drug,such as Decitabine<br>Drug: Chemotherapy regimen<br>* Chemotherapy regimen,such as CAG, G-CSF 5-10ug/kg/day on days 4 and 17；Aclacinomycin 7mg/m2/day on days 4 and 11；Cytarabine 20mg/m2/day on days 4 and 17.<br>|
| No Therapy pre-transplantation<br>No therapy (chemotherapy or demethylation drugs) was given pre-transplantation for patients with RAEB-1, REAB-2 and AML Secondary to MDS (bone marrow blast cells less than 50%). | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| overall survival (OS) |  | 2 year | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| relapse rate |  | 2 year | 
| disease-free survival (DFS) |  | 2 year | 
| transplant-related mortality (TRM) |  | 2 year | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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chemotherapy