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

• Conditions: Myelodysplastic Syndrome; Chemotherapy
• Interventions: Drug: Demethylation drug; Drug: Chemotherapy regimen

• Registration Number: NCT02850822
• Lead Sponsor: Nanfang Hospital, Southern Medical University

Brief Summary

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

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.

Study Timeline

• Status Verified: 2016-07
• Study Start: 2016-07
• Study First Submitted: 2016-07-20
• Study First Submitted QC: 2016-07-29
• Study First Posted: 2016-08-01
• Last Update Submitted: 2017-12-06
• Last Update Posted: 2017-12-08
• Primary Completion: 2019-06
• Study Completion: 2020-06

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 250

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)

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Therapy pre-transplantation	Demethylation drug	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%).
Therapy pre-transplantation	Chemotherapy regimen	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%).

Primary Outcome Measures

Name	Time	Method
overall survival (OS)	2 year

Secondary Outcome Measures

Name	Time	Method
disease-free survival (DFS)	2 year
relapse rate	2 year
transplant-related mortality (TRM)	2 year

Trial Locations

Locations (1)

Department of Hematology,Nanfang Hospital, Southern Medical University; 🇨🇳 Guangzhou, Guangdong, China