Idarubicin Plus Cytarabine (IA) vs IA Plus Cladribine (IAC) as Induction Regimen to Treat Initially Diagnosed Acute Myeloid Leukemia (AML)
IAC Regimen Versus IA Regimen as Induction Treatment for Initially Diagnosed AML Patients: a Randomized Controlled Phase III Clinical Trial
1 other identifier
interventional
618
1 country
1
Brief Summary
The goal of this clinical trial is to compare the clinical efficacy and safety of IAC regimen and IA regimen as induction chemotherapy for initial diagnosed acute myeloid leukemia (AML) patients. The main question it aims to answer is:
- Does IAC regimen higher the complete remission rate in initial diagnosed AML patients? Researchers will compare IAC regimen to IA regimen to see if IAC works to treat AML. Participants will:
- Receive IAC or IA as induction regimen
- Receive a second cycle of re-induction if partial remission
- Visit the clinic once every 3 to 6 months for assessment
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_3
Started Dec 2014
Longer than P75 for phase_3
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
December 1, 2014
CompletedFirst Submitted
Initial submission to the registry
December 12, 2014
CompletedFirst Posted
Study publicly available on registry
December 23, 2014
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 1, 2020
CompletedStudy Completion
Last participant's last visit for all outcomes
January 1, 2022
CompletedJuly 30, 2024
July 1, 2024
5.3 years
December 12, 2014
July 28, 2024
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Complete Remission Rate
complete remission (CR) rate after the induction courses
1-2 months
Secondary Outcomes (3)
Overall Survival
2 years
Disease-Free Survival
2 years
Cumulative Incidence of Relapse (CIR)
2 years
Study Arms (2)
IAC regimen
EXPERIMENTALReceive IAC induction therapy
IA regimen
ACTIVE COMPARATORReceive an IA induction therapy
Interventions
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)
Induction treatment for initially diagnosed AML with IAC regimen, including Ara-C 100mg/msq/d (d1-7) and IDA 12mg/msq/d (d1-3)
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- AML secondary to chronic leukemia and myeloproliferative neoplasms (MPNs)
- With other underlying malignancies
- Severe and uncontrolled infection
- Intolerant to the chemotherapy
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
The First Affiliated Hospital of Soochow University
Suzhou, Jiangsu, 215006, China
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Depei Wu, M.D., Ph.D.
The First Affiliated Hospital of Soochow University
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
December 12, 2014
First Posted
December 23, 2014
Study Start
December 1, 2014
Primary Completion
March 1, 2020
Study Completion
January 1, 2022
Last Updated
July 30, 2024
Record last verified: 2024-07