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

Phase 3

Completed

• Conditions: Acute Myeloid Leukemia
• Interventions: Drug: IA regimen; Drug: IAC regimen

• Registration Number: NCT02323022
• Lead Sponsor: The First Affiliated Hospital of Soochow University

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

Detailed Description

Not available

Study Timeline

• Study Start: 2014-12
• Study First Submitted: 2014-12-12
• Study First Submitted QC: 2014-12-17
• Study First Posted: 2014-12-23
• Primary Completion: 2020-03
• Study Completion: 2022-01
• Status Verified: 2024-07
• Last Update Submitted: 2024-07-28
• Last Update Posted: 2024-07-30

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 618

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
IA regimen	IA regimen	Receive an IA induction therapy
IAC regimen	IAC regimen	Receive IAC induction therapy

Primary Outcome Measures

Name	Time	Method
Complete Remission Rate	1-2 months	complete remission (CR) rate after the induction courses

Secondary Outcome Measures

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

Trial Locations

Locations (1)

The First Affiliated Hospital of Soochow University; 🇨🇳 Suzhou, Jiangsu, China