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

Nanfang Hospital, Southern Medical University

Status and phase: Completed; Phase 3; Phase 2

Conditions: Conditioning; Autologous Hematopoietic Stem Cell Transplantation; Acute Myeloid Leukemia

Treatments: Drug: Idarubicin（IDA）; Drug: Busulfan (BU); Drug: Cyclophosphamide (CY)

Study type: Interventional

Funder types: Other

Identifiers

NCT02671708

IDA+BUCY vs BUCY-AML-2016

Details and patient eligibility

About

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.

Full 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.

Enrollment: 153 patients

Sex: All

Ages: 14 to 65 years old

Volunteers: No Healthy Volunteers

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)

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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153 participants in 2 patient groups

IDA+BUCY

Experimental group

Description:

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.

Treatment:

Drug: Busulfan (BU)

Drug: Cyclophosphamide (CY)

Drug: Idarubicin（IDA）

BUCY

Active Comparator group

Description:

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.

Treatment:

Drug: Busulfan (BU)

Drug: Cyclophosphamide (CY)