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

Study Overview
=================
Brief 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.

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.

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

Conditions
-----------------
Autologous Hematopoietic Stem Cell Transplantation, Acute Myeloid Leukemia, Conditioning

Intervention / Treatment
-----------------
* Drug: Idarubicin（IDA）
* Drug: Busulfan (BU)
* Drug: Cyclophosphamide (CY)


Participation Criteria
=================
Eligibility Criteria
-----------------
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)

Ages Eligible for Study
-----------------
Minimum Age: 14 Years
Maximum Age: 65 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: IDA+BUCY<br>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）<br>* Idarubicin was administered at 15mg/m2/day on days -12 and -10.<br>Drug: Busulfan (BU)<br>* Busulfan was administered at 3.2 mg/kg/day on days -7 to -4.<br>Drug: Cyclophosphamide (CY)<br>* Cyclophosphamide was administered at 60 mg/kg/day on days -3 to -2.<br>|
| Active Comparator: BUCY<br>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)<br>* Busulfan was administered at 3.2 mg/kg/day on days -7 to -4.<br>Drug: Cyclophosphamide (CY)<br>* Cyclophosphamide was administered at 60 mg/kg/day on days -3 to -2.<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| leukemia relapse rate |  | 2 year | 

Secondary Outcome Measures

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