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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT02850822
Other study ID # Therapy vs Notherapy-MDS-2016
Secondary ID
Status Recruiting
Phase N/A
First received July 20, 2016
Last updated December 6, 2017
Start date July 2016
Est. completion date June 2020

Study information

Verified date July 2016
Source Nanfang Hospital of Southern Medical University
Contact Qifa Liu
Phone 020-62787883
Email liuqifa628@163.com
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial 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.


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.


Recruitment information / eligibility

Status Recruiting
Enrollment 250
Est. completion date June 2020
Est. primary completion date June 2019
Accepts healthy volunteers No
Gender All
Age group 14 Years to 65 Years
Eligibility 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


Intervention

Drug:
Demethylation drug
Demethylation drug,such as Decitabine
Chemotherapy regimen
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.

Locations

Country Name City State
China Department of Hematology,Nanfang Hospital, Southern Medical University Guangzhou Guangdong

Sponsors (7)

Lead Sponsor Collaborator
Nanfang Hospital of Southern Medical University Fujian Medical University Union Hospital, Guangzhou First People's Hospital, Peking University People's Hospital, Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University, Third Affiliated Hospital, Sun Yat-Sen University, Zhujiang Hospital

Country where clinical trial is conducted

China, 

Outcome

Type Measure Description Time frame Safety issue
Primary overall survival (OS) 2 year
Secondary relapse rate 2 year
Secondary disease-free survival (DFS) 2 year
Secondary transplant-related mortality (TRM) 2 year
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