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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT04098653
Other study ID # Dec+BUCYvsBUCY-Myeloid tumors
Secondary ID
Status Recruiting
Phase Phase 2/Phase 3
First received
Last updated
Start date September 2019
Est. completion date August 2023

Study information

Verified date September 2019
Source Nanfang Hospital of Southern Medical University
Contact Qifa Liu
Phone 020-61641611
Email liuqifa628@163.com
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

Recent studies have demonstrated that allogeneic hematopoietic stem cell transplantation (allo-HSCT) could be a valuable treatment choice for myeloid tumors, such as acute myeloid leukemia and myelodysplastic syndrome. Unfortunately, some patients relapsed after allo-HSCT. In this prospective randomized controlled study, the safety and efficacy of Decitabine + BUCY and BUCY myeloablative conditioning regimens in myeloid tumors undergoing allo-HSCT are evaluated.


Description:

Recent studies have demonstrated that allogeneic hematopoietic stem cell transplantation (allo-HSCT) could be a valuable treatment choice for myeloid tumors, such as acute myeloid leukemia and myelodysplastic syndrome. BUCY conditioning regimen is the standard myeloablative regimen for myeloid tumors undergoing allo-HSCT. However, it appears to have higher relapse rate and lower survival. To reduce the relapse rate and improve the survival, decitabine is added in the conditioning regimen. In this prospective randomized controlled study, the safety and efficacy of Decitabine + BUCY and BUCY myeloablative conditioning regimens in myeloid tumors undergoing allo-HSCT are evaluated.


Recruitment information / eligibility

Status Recruiting
Enrollment 196
Est. completion date August 2023
Est. primary completion date August 2022
Accepts healthy volunteers No
Gender All
Age group 14 Years to 65 Years
Eligibility Inclusion Criteria:

- Myeloid tumors 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


Related Conditions & MeSH terms


Intervention

Drug:
Decitabine
Decitabine was administered at 20mg/m2/day on days -14 and -10.
Busulfan (BU)
Busulfan was administered at 3.2 mg/kg/day on days -7 to -4.
Cyclophosphamide (CY)
Cyclophosphamide was administered at 60 mg/kg/day on days -3 to -2.

Locations

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

Sponsors (5)

Lead Sponsor Collaborator
Nanfang Hospital of Southern Medical University 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 relapse rate 1 year
Secondary overall survival (OS) 1 year
Secondary disease-free survival (DFS) 1 year
Secondary transplant-related mortality (TRM) 1 year
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