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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2/PHASE3

Total Enrollment

153 participants

Study Classification

INTERVENTIONAL

Study Start Date

2016-01-31

Study Completion Date

2020-02-28

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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Autologous Hematopoietic Stem Cell Transplantation Acute Myeloid Leukemia Conditioning

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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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.

Group Type EXPERIMENTAL

Idarubicin（IDA）

Intervention Type DRUG

Idarubicin was administered at 15mg/m2/day on days -12 and -10.

Busulfan (BU)

Intervention Type DRUG

Busulfan was administered at 3.2 mg/kg/day on days -7 to -4.

Cyclophosphamide (CY)

Intervention Type DRUG

Cyclophosphamide was administered at 60 mg/kg/day on days -3 to -2.

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.

Group Type ACTIVE_COMPARATOR

Busulfan (BU)

Intervention Type DRUG

Busulfan was administered at 3.2 mg/kg/day on days -7 to -4.

Cyclophosphamide (CY)

Intervention Type DRUG

Cyclophosphamide was administered at 60 mg/kg/day on days -3 to -2.

Interventions

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Idarubicin（IDA）

Idarubicin was administered at 15mg/m2/day on days -12 and -10.

Intervention Type DRUG

Busulfan (BU)

Busulfan was administered at 3.2 mg/kg/day on days -7 to -4.

Intervention Type DRUG

Cyclophosphamide (CY)

Cyclophosphamide was administered at 60 mg/kg/day on days -3 to -2.

Intervention Type DRUG

Eligibility Criteria

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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)

Minimum Eligible Age

14 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No