Decitabine + BUCY vs BUCY Conditioning Regimen for TP53+ Myeloid Tumors Undergoing Allo-HSCT

Allogeneic Hematopoietic Stem Cell Transplantation Clinical Trial

Official title:

Decitabine+Busulfan+Cyclophosphamide vs Busulfan+Cyclophosphamide Conditioning Regimen for TP53+ Myeloid Tumors Undergoing Allogeneic Hematopoietic Stem Cell Transplantation

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04123392
• Other study ID #: TP53+ Myeloid tumors
• Status: Recruiting
• Phase: Phase 2/Phase 3
• Start date: October 2019
• Est. completion date: September 2023

Study information

• Verified date: October 2019
• Source: Nanfang Hospital of Southern Medical University
• Contact: Qifa Liu
• Phone: 020-61641611
• Email: liuqifa628[@]163.com
• Is FDA regulated: No
• 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 TP53+ 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 TP53+ 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 TP53+ myeloid tumors, such as acute myeloid leukemia and myelodysplastic syndrome. BUCY conditioning regimen is the standard myeloablative regimen for TP53+ 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 TP53+ myeloid tumors undergoing allo-HSCT are evaluated.

Recruitment information / eligibility

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

Eligibility

Inclusion Criteria:

• TP53+ 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)

Related Conditions & MeSH terms

• Allogeneic Hematopoietic Stem Cell Transplantation
• Conditioning
• Myeloid Tumors
• TP53

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	relapse rate	1 year
Secondary	overall survival (OS)	overall survival (OS)	1 year
Secondary	disease-free survival (DFS)	disease-free survival (DFS)	1 year
Secondary	transplant-related mortality (TRM)	transplant-related mortality (TRM)	1 year