Dec+Flu+Bu Conditioning Regimen for Elderly AML in CR Undergoing Allo-HSCT

Acute Myeloid Leukemia Clinical Trial

Official title:

Decitabine+ Fludarabine+Busulfan Conditioning Regimen for Elderly Acute Myeloid Leukemia in Complete Remission Undergoing Allogeneic Hematopoietic Stem Cell Transplantation

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03530085
• Other study ID #: Dec+FB-Elderly AML-2018
• Status: Recruiting
• Phase: Phase 2/Phase 3
• Start date: June 15, 2018
• Est. completion date: April 1, 2022

Study information

• Verified date: December 2020
• Source: Nanfang Hospital of Southern Medical University
• Contact: Li Xuan
• Phone: 008615521251270
• Email: 356135708[@]qq.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

Allogeneic hematopoietic stem cell transplantation (allo-HSCT) is reported to be able to improve the outcomes for elderly acute myeloid leukemia (AML) in complete remission (CR). At present, the best conditioning regimen for elderly AML in CR remains in discussion. In this prospective study, the safety and efficacy of Dec+Flu+Bu myeloablative conditioning regimens in patients with elderly AML in CR undergoing allo-HSCT are evaluated.

Description:

Allogeneic hematopoietic stem cell transplantation (allo-HSCT) is reported to be able to improve the outcomes for elderly AML(older than 60 years) in complete remission (CR). At present, the best conditioning regimen for elderly AML in CR remains in discussion. Flu+Bu conditioning regimen is the most commonly used regimen for elderly AML in CR undergoing allo-HSCT. However, it appears to have higher relapse rate. To reduce the relapse rate, decitabine is added in the conditioning regimen. In this prospective study, the safety and efficacy of Decitabine+ Fludarabine+Busulfan myeloablative conditioning regimens in patients with elderly AML in CR undergoing allo-HSCT are evaluated.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 60
• Est. completion date: April 1, 2022
• Est. primary completion date: April 1, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 60 Years to 80 Years

Eligibility

Inclusion Criteria:

• AML patients older than 60 years, younger than 80 years

• In complete remission before transplantation

• With HLA-matched sibling donors

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

• Acute Myeloid Leukemia
• Allogeneic Hematopoietic Stem Cell Transplantation
• Conditioning
• Elderly
• Leukemia
• Leukemia, Myeloid
• Leukemia, Myeloid, Acute

Intervention

Drug:
• Decitabine
Decitabine was administered at 20mg/m2/day on days -9 to -7.
• Busulfan (BU)
Busulfan was administered at 3.2 mg/kg/day on days -5 to -4.
• Fludarabine(Flu)
Fludarabine(Flu) was administered at 30mg/m2/day on days -6 to -3.

Locations

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

Sponsors (6)

Lead Sponsor	Collaborator
Nanfang Hospital of Southern Medical University	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	disease-free survival (DFS)		2 year
Secondary	relapse		2 year
Secondary	transplant-related mortality (TRM)		2 year