MedTrace Logo

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

NCT02323022 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 618

Last updated 2024-07-30

No results posted yet for this study

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

Conditions

Interventions

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)

DRUG

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)

Sponsors & Collaborators

  • The First Affiliated Hospital of Soochow University

    lead OTHER

Principal Investigators

  • Depei Wu, M.D., Ph.D. · The First Affiliated Hospital of Soochow University

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
60 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2014-12-31
Primary Completion
2020-03-31
Completion
2022-01-31

Countries

  • China

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02323022 on ClinicalTrials.gov