NCT03530085

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

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

• Status: Unknown
• Phase: Phase 2 / Phase 3
• Study type: Interventional
• Enrollment: 60 (estimated)
• Sponsor: Nanfang Hospital, Southern Medical University · Academic / Other
• Sex: All
• Age: 60 Years – 80 Years
• Healthy volunteers: Not accepted

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.

Detailed 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.

Conditions

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

Interventions

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

Timeline

• Start date: 2018-06-15
• Primary completion: 2021-04-01
• Completion: 2022-04-01
• First posted: 2018-05-21
• Last updated: 2020-12-22

Locations

1 site across 1 country: China