Back to resultsIdarubicin Plus Cytarabine (IA) vs IA Plus Cladribine (IAC) as Induction Regimen to Treat Initially Diagnosed Acute Myeloid Leukemia (AML)
Primary Purpose
Acute Myeloid Leukemia
Status
Unknown status
Phase
Phase 3
Locations
China
Study Type
Interventional
Intervention
IAC regimen
High-dose IA regimen
Intermediate-dose IA regimen
Sponsored by
About this trial
This is an interventional treatment trial for Acute Myeloid Leukemia focused on measuring AML, cladribine, induction therapy
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
Sites / Locations
- The First Affiliated Hospital of Soochow UniversityRecruiting
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Experimental
Active Comparator
Active Comparator
Arm Label
IAC regimen
High-dose IA regimen
Intermediate-dose IA regimen
Arm Description
Patients in this arm will receive an IAC induction therapy
Patients in this arm will receive an IA induction therapy, in which the idarubicin dose should be 10mg/msq/d
Patients in this arm will receive an IA induction therapy, in which the idarubicin dose should be 12mg/msq/d
Outcomes
Primary Outcome Measures
Complete Remission Rate
Disease-Free Survival
Secondary Outcome Measures
Treatment related mortality
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
Treatment related toxicities
Include evaluation of adverse events according to Common Toxicity Criteria for Adverse Effects (CTCAE) version 4.0
Full Information
NCT ID
NCT02323022
First Posted
December 12, 2014
Last Updated
February 3, 2020
Sponsor
The First Affiliated Hospital of Soochow University
1. Study Identification
Unique Protocol Identification Number
NCT02323022
Brief Title
Idarubicin Plus Cytarabine (IA) vs IA Plus Cladribine (IAC) as Induction Regimen to Treat Initially Diagnosed Acute Myeloid Leukemia (AML)
Official Title
IAC Regimen Versus IA Regimen as Induction Treatment for Initially Diagnosed AML Patients: a Randomized Controlled Phase III Clinical Trial
Study Type
Interventional
2. Study Status
Record Verification Date
February 2020
Overall Recruitment Status
Unknown status
Study Start Date
December 2014 (undefined)
Primary Completion Date
December 2020 (Anticipated)
Study Completion Date
December 2022 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
The First Affiliated Hospital of Soochow University
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Acute Myeloid Leukemia
Keywords
AML, cladribine, induction therapy
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
840 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
IAC regimen
Arm Type
Experimental
Arm Description
Patients in this arm will receive an IAC induction therapy
Arm Title
High-dose IA regimen
Arm Type
Active Comparator
Arm Description
Patients in this arm will receive an IA induction therapy, in which the idarubicin dose should be 10mg/msq/d
Arm Title
Intermediate-dose IA regimen
Arm Type
Active Comparator
Arm Description
Patients in this arm will receive an IA induction therapy, in which the idarubicin dose should be 12mg/msq/d
Intervention Type
Drug
Intervention Name(s)
IAC regimen
Intervention Description
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)
Intervention Type
Drug
Intervention Name(s)
High-dose IA regimen
Intervention Description
Induction treatment for initially diagnosed AML with IAC regimen, including Ara-C 100mg/msq/d (d1-7) and IDA 12mg/msq/d (d1-3)
Intervention Type
Drug
Intervention Name(s)
Intermediate-dose IA regimen
Intervention Description
Induction treatment for initially diagnosed AML with IAC regimen, including Ara-C 100mg/msq/d (d1-7) and IDA 10mg/msq/d (d1-3)
Primary Outcome Measure Information:
Title
Complete Remission Rate
Time Frame
3 months
Title
Disease-Free Survival
Time Frame
3 years
Secondary Outcome Measure Information:
Title
Treatment related mortality
Time Frame
3 years
Title
Cumulative incidence of relapse
Description
Relapse events will be recorded in case report file, and finally be analyzed by Kaplan-Meier method, and log-rank test among three arms
Time Frame
3 years
Title
Treatment related toxicities
Description
Include evaluation of adverse events according to Common Toxicity Criteria for Adverse Effects (CTCAE) version 4.0
Time Frame
6 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
No
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Jia CHEN, M.D.
Phone
+86 512 67781856
Email
drchenjia@163.com
First Name & Middle Initial & Last Name or Official Title & Degree
Xiang Zhang, M.D.
Phone
+86 512 67781856
Email
lcsy2013@sina.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Depei Wu, M.D., Ph.D.
Organizational Affiliation
The First Affiliated Hospital of Soochow University
Official's Role
Principal Investigator
Facility Information:
Facility Name
The First Affiliated Hospital of Soochow University
City
Suzhou
State/Province
Jiangsu
ZIP/Postal Code
215006
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jia Chen, M.D.
Phone
+86 512 6778 1856
Email
chenjiasuzhou@gmail.com
12. IPD Sharing Statement
Learn more about this trial
Idarubicin Plus Cytarabine (IA) vs IA Plus Cladribine (IAC) as Induction Regimen to Treat Initially Diagnosed Acute Myeloid Leukemia (AML)
We'll reach out to this number within 24 hrs