Overview

This trial is active, not recruiting.

Conditions autologous hematopoietic stem cell transplantation, acute myeloid leukemia, conditioning
Treatments idarubicin(ida), busulfan (bu), cyclophosphamide (cy)
Phase phase 2/phase 3
Sponsor Nanfang Hospital of Southern Medical University
Collaborator Sun Yat-sen University
Start date January 2016
End date December 2018
Trial size 80 participants
Trial identifier NCT02671708, IDA+BUCY vs BUCY-AML-2016

Summary

Autologous hematopoietic stem cell transplantation (Auto-HSCT) is an effective alternative to allogeneic HSCT for low-risk and intermediate-risk acute myeloid leukemia (AML) without HLA-matched donors. At present, the best conditioning regimen for AML undergoing auto-HSCT remains in discussion. In this study, the safety and efficacy of IDA+BUCY and BUCY myeloablative conditioning regimens in low-risk and intermediate-risk AML undergoing auto-HSCT are evaluated.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification safety/efficacy study
Intervention model parallel assignment
Masking open label
Primary purpose treatment
Arm
(Experimental)
For low-risk and intermediate-risk AML undergoing auto-HSCT,IDA+BUCY conditioning regimen was IDA 15mg/m2/day on days -11 and -9;BU 3.2 mg/kg/day on days -7 and -4;CY 60 mg/kg/day on days -3 and -2.
idarubicin(ida)
Idarubicin was administered at 15mg/m2/day on days -11 and -9.
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.
(Active Comparator)
For low-risk and intermediate-risk AML undergoing auto-HSCT,BUCY conditioning regimen was BU 3.2 mg/kg/day on days -7 and -4;CY 60 mg/kg/day on days -3 and -2.
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.

Primary Outcomes

Measure
overall survival (OS)
time frame: 2 year

Secondary Outcomes

Measure
leukemia relapse rate
time frame: 2 year
disease-free survival (DFS)
time frame: 2 year
transplant-related mortality (TRM)
time frame: 2 year

Eligibility Criteria

Male or female participants from 14 years up to 65 years old.

Inclusion Criteria: - Low-risk and intermediate-risk AML - Achieving CR after one cycle induction,then receiving three cycles of consolidation therapy including moderate and high doses of Ara-c combined regimens - With negative MRD before mobilization and collect of peripheral blood stem cells - Without HLA-matched donors (related and unrelated) 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)

Additional Information

Official title Idarubicin+Busulfan+Cyclophosphamide vs Busulfan+Cyclophosphamide Conditioning Regimen for Low-risk and Intermediate-risk Acute Myeloid Leukemia Undergoing Autologous Hematopoietic Stem Cell Transplantation
Principal investigator Qifa Liu
Description Auto-HSCT is an effective alternative to allogeneic HSCT for low-risk and intermediate-risk AML without HLA-matched donors. BUCY conditioning regimen is the standard myeloablative regimen for AML undergoing auto-HSCT. However, auto-HSCT appears to have higher relapse rate but lower transplant-related mortality, compared with allo-HSCT. To reduce the relapse rate, IDA is added in the conditioning regimen. In this study, the safety and efficacy of IDA+BUCY and BUCY myeloablative conditioning regimens in low-risk and intermediate-risk AML patients undergoing auto-HSCT are evaluated.
Trial information was received from ClinicalTrials.gov and was last updated in January 2016.
Information provided to ClinicalTrials.gov by Nanfang Hospital of Southern Medical University.