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

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

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.

Study Overview

• Status: Completed
• Conditions: Acute Myeloid Leukemia; Conditioning; Autologous Hematopoietic Stem Cell Transplantation
• Intervention / Treatment: Drug: Idarubicin（IDA）; Drug: Busulfan (BU); Drug: Cyclophosphamide (CY)

Detailed 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.

• Study Type: Interventional
• Enrollment (Actual): 153
• Phase: Phase 2; Phase 3

Contacts and Locations

Study Locations

• China
  • Guangdong
    • Guangzhou, Guangdong, China, 510515
      • Department of Hematology,Nanfang Hospital, Southern Medical University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 14 years to 65 years (Child, Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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)

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: IDA+BUCY; For intermediate-risk AML undergoing auto-HSCT，IDA+BUCY conditioning regimen was IDA 15mg/m2/day on days -12 and -10；BU 3.2 mg/kg/day on days -7 and -4；CY 60 mg/kg/day on days -3 and -2.	Drug: Idarubicin（IDA）; Idarubicin was administered at 15mg/m2/day on days -12 and -10.; Drug: Busulfan (BU); Busulfan was administered at 3.2 mg/kg/day on days -7 to -4.; Drug: Cyclophosphamide (CY); Cyclophosphamide was administered at 60 mg/kg/day on days -3 to -2.
Active Comparator: BUCY; For 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.	Drug: Busulfan (BU); Busulfan was administered at 3.2 mg/kg/day on days -7 to -4.; Drug: Cyclophosphamide (CY); Cyclophosphamide was administered at 60 mg/kg/day on days -3 to -2.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
leukemia relapse rate	2 year

Secondary Outcome Measures

Outcome Measure	Time Frame
overall survival (OS)	2 year
disease-free survival (DFS)	2 year
transplant-related mortality (TRM)	2 year

Collaborators and Investigators

• Sponsor: Nanfang Hospital of Southern Medical University
• Collaborators: Peking University People's Hospital; Guangzhou First People's Hospital; Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University; Zhujiang Hospital; Third Affiliated Hospital, Sun Yat-Sen University

Study record dates

Study Major Dates

• Study Start: January 1, 2016
• Primary Completion (Actual): February 28, 2019
• Study Completion (Actual): February 28, 2020

Study Registration Dates

• First Submitted: January 30, 2016
• First Submitted That Met QC Criteria: January 30, 2016
• First Posted (Estimate): February 2, 2016

Study Record Updates

• Last Update Posted (Actual): March 3, 2020
• Last Update Submitted That Met QC Criteria: March 2, 2020
• Last Verified: March 1, 2019

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Neoplasms by Histologic Type; Neoplasms; Leukemia; Leukemia, Myeloid; Leukemia, Myeloid, Acute; Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Enzyme Inhibitors; Antirheumatic Agents; Antineoplastic Agents; Immunosuppressive Agents; Immunologic Factors; Antineoplastic Agents, Alkylating; Alkylating Agents; Myeloablative Agonists; Topoisomerase II Inhibitors; Topoisomerase Inhibitors; Antibiotics, Antineoplastic; Cyclophosphamide; Idarubicin; Busulfan
• Other Study ID Numbers: IDA+BUCY vs BUCY-AML-2016

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Yes