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

Last updated: December 6, 2017
Sponsor: Nanfang Hospital of Southern Medical University
Overall Status: Active - Recruiting

Phase

N/A

Condition

Chemotherapy

Red Blood Cell Disorders

Platelet Disorders

Treatment

N/A

Clinical Study ID

NCT02850822
Therapy vs Notherapy-MDS-2016
  • Ages 14-65
  • All Genders

Study 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.

Eligibility Criteria

Inclusion

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

Exclusion Criteria:

  • Any abnormality in a vital sign (e.g., heart rate, respiratory rate, or bloodpressure)

  • Patients with any conditions not suitable for the trial (investigators' decision)

Study Design

Total Participants: 250
Study Start date:
July 01, 2016
Estimated Completion Date:
June 30, 2020

Study 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.

Connect with a study center

  • Department of Hematology,Nanfang Hospital, Southern Medical University

    Guangzhou, Guangdong 510515
    China

    Active - Recruiting

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