Idarubicin Plus Cytarabine (IA) vs IA Plus Cladribine (IAC) as Induction Regimen to Treat Initially Diagnosed Acute Myeloid Leukemia (AML)

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to compare the clinical efficacy and safety of IAC regimen and IA regimen as induction chemotherapy for initial diagnosed AML patients. 840 cases are supposed to recruited in 3 years.

Official Title
-----------------
IAC Regimen Versus IA Regimen as Induction Treatment for Initially Diagnosed AML Patients: a Randomized Controlled Phase III Clinical Trial

Conditions
-----------------
Acute Myeloid Leukemia

Intervention / Treatment
-----------------
* Drug: IAC regimen
* Drug: High-dose IA regimen
* Drug: Intermediate-dose IA regimen


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Initially diagnosed as AML (except APL) Aged between 18 and 60 year old Eastern Cooperative Oncology Group (ECOG) score no more than 3 Informed consent file (ICF) signed Exclusion Criteria: AML secondary to chronic leukemia and myeloproliferative disease (MPD) APL With underlying malignancies except AML Uncontrolled severe infection Intolerant to chemotherapy organically including: Heart failure: ejection fraction (EF) less than 30%, and New York Heart Association (NYHA) grading high than Grade II Liver and kidney dysfunction: serum bilirubin≥2mg/dl, AST≥2.5*upper limit of normal (ULN), serum creatine≥2.5mg/dl Refuse to participate the trial

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 60 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: IAC regimen<br>Patients in this arm will receive an IAC induction therapy | Drug: IAC regimen<br>* Induction treatment for initially diagnosed AML with IAC regimen, including Cladribine 5mg/msq/d (d1-5), Ara-C 100mg/msq/d(d1-7) and IDA 8mg/msq/d (d1-3)<br>|
| Active Comparator: High-dose IA regimen<br>Patients in this arm will receive an IA induction therapy, in which the idarubicin dose should be 10mg/msq/d | Drug: High-dose IA regimen<br>* Induction treatment for initially diagnosed AML with IAC regimen, including Ara-C 100mg/msq/d (d1-7) and IDA 12mg/msq/d (d1-3)<br>|
| Active Comparator: Intermediate-dose IA regimen<br>Patients in this arm will receive an IA induction therapy, in which the idarubicin dose should be 12mg/msq/d | Drug: Intermediate-dose IA regimen<br>* Induction treatment for initially diagnosed AML with IAC regimen, including Ara-C 100mg/msq/d (d1-7) and IDA 10mg/msq/d (d1-3)<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Complete Remission Rate |  | 3 months | 
| Disease-Free Survival |  | 3 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Treatment related mortality |  | 3 years | 
| Cumulative incidence of relapse | Relapse events will be recorded in case report file, and finally be analyzed by Kaplan-Meier method, and log-rank test among three arms | 3 years | 
| Treatment related toxicities | Include evaluation of adverse events according to Common Toxicity Criteria for Adverse Effects (CTCAE) version 4.0 | 6 months | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
induction therapy, AML, cladribine