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NCT Number: NCT02323022

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

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

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Key information

Conditions

Acute Myeloid Leukemia Hematologic Diseases Hemic and Lymphatic Diseases Leukemia Leukemia, Myeloid Leukemia, Myeloid, Acute Neoplasms Neoplasms by Histologic Type

Age range

18 year–60 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

The First Affiliated Hospital of Soochow University

Suzhou, Jiangsu, 215006, China

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

IAC regimen

Drug

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)

IA regimen

Drug

Induction treatment for initially diagnosed AML with IAC regimen, including Ara-C 100mg/msq/d (d1-7) and IDA 12mg/msq/d (d1-3)

Primary outcomes

  1. Complete Remission Rate

    Time frame: 1-2 months

    complete remission (CR) rate after the induction courses

Secondary outcomes

  1. Overall Survival

    Time frame: 2 years

    2-year overall survival (OS)

  2. Disease-Free Survival

    Time frame: 2 years

    2-year disease-free survival (DFS)

  3. Cumulative Incidence of Relapse (CIR)

    Time frame: 2 years

    2-year cumulative incidence of relapse (CIR)

Sponsors and collaborators

Lead sponsor

The First Affiliated Hospital of Soochow University

Other

Registry information

Official study title

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

Important dates

Study start
2014
Primary completion
2020
Study completion
2022
First posted
Dec 23, 2014
Registry last updated
Jul 30, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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