IDA+BUCY vs BUCY Conditioning Regimen for Intermediate-risk AML Undergoing Auto-HSCT

Acute Myeloid Leukemia Clinical Trial

Official title:

Idarubicin+Busulfan+Cyclophosphamide vs Busulfan+Cyclophosphamide Conditioning Regimen for Intermediate-risk Acute Myeloid Leukemia Undergoing Autologous Hematopoietic Stem Cell Transplantation

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02671708
• Other study ID #: IDA+BUCY vs BUCY-AML-2016
• Status: Completed
• Phase: Phase 2/Phase 3
• Start date: January 2016
• Est. completion date: February 28, 2020

Study information

• Verified date: March 2019
• Source: Nanfang Hospital of Southern Medical University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

Autologous hematopoietic stem cell transplantation (Auto-HSCT) is an effective alternative to allogeneic HSCT for 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 intermediate-risk AML undergoing auto-HSCT are evaluated.

Description:

Auto-HSCT is an effective alternative to allogeneic HSCT for intermediate-risk AML without HLA-matched donors. BUCY conditioning regimen is the standard myeloablative regimen. However, auto-HSCT with BUCY conditioning regimen appears to have higher relapse rate. 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 intermediate-risk AML patients undergoing auto-HSCT are evaluated.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 153
• Est. completion date: February 28, 2020
• Est. primary completion date: February 28, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 14 Years to 65 Years

Eligibility

Inclusion Criteria:

• 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)

• Refusal of haploidentical hematopoietic stem cell transplantation

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
• Autologous Hematopoietic Stem Cell Transplantation
• Conditioning
• Leukemia
• Leukemia, Myeloid
• Leukemia, Myeloid, Acute

Intervention

Drug:
• Idarubicin(IDA)
Idarubicin was administered at 15mg/m2/day on days -12 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 (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	leukemia relapse rate		2 year
Secondary	overall survival (OS)		2 year
Secondary	disease-free survival (DFS)		2 year
Secondary	transplant-related mortality (TRM)		2 year