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Efficacy of Idarubicin, Cytarabine and Cyclophosphamide (IAC) Regimen in Relapsed/Refractory AML

NCT02937662 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 20

Last updated 2025-05-30

No results posted yet for this study

Summary

In this multi-center, randomized, open-label, prospective clinical trial, a total of 60 relapsed/refractory AML patients will be randomized into 2 groups. In the experimental arm, patients receive IAC regimen. In the control arm, patients receive other physician-directed regimen. The primary end point is complete remission rate.

Conditions

Interventions

DRUG

Idarubicin

Idarubicin at a dose of 10 mg/㎡/d on days 1-3.

DRUG

Cytarabine

Cytarabine at a dose of 100mg/㎡/d on days 1-7.

DRUG

Cyclophosphamide

Cyclophosphamide at a dose of 350mg/㎡/d on the second day and the fifth day.

DRUG

Physician-Directed Regimens without Cyclophosphamide

Regimen without cyclophosphamide including FLA±G regimen, DA regimen, AAG regimen, decitabine with AA regimen.

Sponsors & Collaborators

  • Institute of Hematology & Blood Diseases Hospital, China

    lead OTHER

Principal Investigators

  • Jianxiang Wang, Dr · Institute of Hematology & Blood Diseases Hospital, China

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

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

Timeline & Regulatory

Start
2016-10-31
Primary Completion
2020-04-30
Completion
2020-04-30

Countries

  • China

Study Locations

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Entities

Drugs
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 NCT02937662 on ClinicalTrials.gov