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

Status

Completed

Phases

Phase 3

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT02323022

Enrollment

618

Registered

2014-12-23

Start date

2014-12-31

Completion date

2022-01-31

Last updated

2024-07-30

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Acute Myeloid Leukemia

Keywords

Acute Myeloid Leukemia

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

Interventions

DRUGIAC 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)

DRUGIA 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)

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to 60 Years

Healthy volunteers

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 neoplasms (MPNs) * With other underlying malignancies * Severe and uncontrolled infection * Intolerant to the chemotherapy

Design outcomes

Primary

Measure	Time frame	Description
Complete Remission Rate	1-2 months	complete remission (CR) rate after the induction courses

Secondary

Measure	Time frame	Description
Overall Survival	2 years	2-year overall survival (OS)
Disease-Free Survival	2 years	2-year disease-free survival (DFS)
Cumulative Incidence of Relapse (CIR)	2 years	2-year cumulative incidence of relapse (CIR)

Countries

China

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026