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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

618 participants

Study Classification

INTERVENTIONAL

Study Start Date

2014-12-31

Study Completion Date

2022-01-31

Brief Summary

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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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Detailed Description

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Conditions

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Acute Myeloid Leukemia

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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IAC regimen

Receive IAC induction therapy

Group Type EXPERIMENTAL

IAC regimen

Intervention Type 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

Receive an IA induction therapy

Group Type ACTIVE_COMPARATOR

IA regimen

Intervention Type 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)

Interventions

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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)

Intervention Type 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)

Intervention Type DRUG

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Maximum Eligible Age

60 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No