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

February 3, 2020 updated by: The First Affiliated Hospital of Soochow University

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

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

840

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • China
    • Jiangsu
      • Suzhou, Jiangsu, China, 215006
        • Recruiting
        • The First Affiliated Hospital of Soochow University
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

16 years to 58 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: IAC regimen
Patients in this arm will receive an IAC induction therapy
Drug: IAC regimen
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)
Active Comparator: High-dose IA regimen
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
Induction treatment for initially diagnosed AML with IAC regimen, including Ara-C 100mg/msq/d (d1-7) and IDA 12mg/msq/d (d1-3)
Active Comparator: Intermediate-dose IA regimen
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
Induction treatment for initially diagnosed AML with IAC regimen, including Ara-C 100mg/msq/d (d1-7) and IDA 10mg/msq/d (d1-3)

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Treatment related mortality
Time Frame: 3 years
3 years
Cumulative incidence of relapse
Time Frame: 3 years
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
Time Frame: 6 months
Include evaluation of adverse events according to Common Toxicity Criteria for Adverse Effects (CTCAE) version 4.0
6 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

The First Affiliated Hospital of Soochow University

Investigators

  • Principal Investigator: Depei Wu, M.D., Ph.D., The First Affiliated Hospital of Soochow University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

December 1, 2014

Primary Completion (Anticipated)

December 1, 2020

Study Completion (Anticipated)

December 1, 2022

Study Registration Dates

First Submitted

December 12, 2014

First Submitted That Met QC Criteria

December 17, 2014

First Posted (Estimate)

December 23, 2014

Study Record Updates

Last Update Posted (Actual)

February 5, 2020

Last Update Submitted That Met QC Criteria

February 3, 2020

Last Verified

February 1, 2020

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • SZ3202

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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