Idarubicin at Different Dosages as Induction Therapy for Newly Diagnosed Acute Myeloid Leukaemia

October 27, 2014 updated by: Guangdong Provincial People's Hospital

A Phase IV, Randomized Study to Evaluate the Safety and Efficacy of Idarubicin at Different Dosages Combined With Cytarabine as Induction Therapy for Newly Diagnosed Acute Myeloid Leukaemia

Study Design: Treatment, Randomized, Open Label, Parallel Assignment This study is an open randomized and controlled trial aiming at assessing the efficacy and safety of Idarubicin (IDA) at different doses of 8mg/m2 and 10mg/m2 combined with cytarabine as induction therapy for newly diagnosed Acute Myeloid Leukaemia (AML). All the recruited patients are allocated to group A ( 8mg/m2 group) or group B ( 10mg/m2) in random. It is advised that induction therapy should begain not late than 3 days after randomization. The regimens in detail can be refered in the therapy protocol.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Detailed Description

Idarubicin is a new generation of anthracyclines with high lipophilicity and is more permeable to cytomembrane and therefore is more cytotoxic to leukemic cells. It can pass through the blood brain barrier easily. so IDA has more advantages over other anthracyclines in prolonging the overall survival for AML. The induction therapy with idarubicin and cytarabine is now the first-line induction regimen for AML. Many clinical trails have indicated that the dosage of IDA is positively correlated with its effectiveness. But in China IDA has been used in varied dosages ranging from 6 to 12 mg/m2. In most Chinese hospitals, the usual dosage range of IDA is from 6 to 8 mg/m2 which may contribute to the much lower 5-year survival rates of AML reported in Chinese medical literature than those in foreign literature. What is the suitable dosage of IDA as induction therapy for Chinese AML population with the best efficacy but the lest increase of side effects? Till now there is no retrospective, randomized and multicentered clinical trails to answer this question on remission-inducing dosages of IDA. All the existing trials till now are just small- sampled , single-centered , retrospective and non-randomized which can not provide strong evidences .

This study aims at comparing two induction doses of 8mg/m2 and 10mg/m2 of IDA with the method of prospective randomized and multi-centered trial.The two doses of IDA have been used in many Chinese hospitals for many years, its effectiveness and safety have been recognized. This trail aims at the and side effects of IDA during induction therapy and its effect on the long-term survival of Chinese AML population, so it can provide strong evidences for optimal dosage of IDA for Chinese AML population.It can not only reduce the waste of medical social resources but also produce good social and economic benefits.

Study Type

Interventional

Enrollment (Anticipated)

400

Phase

  • Phase 4

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

14 years to 60 years (Child, Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Age: 14~60 years old;no gender limit.
  • Diagnosis: according to the diagnosis standards of AML( with the exception of M3 ) ( according to 2008 WHO diagnosis criteria of AML ).
  • Performance status is not bad with Eastern Cooperative Oncology Group (ECOG) score ≤3.
  • Research subjects must sign the informed consent documents.

Exclusion Criteria:

  • Chronic myelogenous leukemia (CML) in crisis phase.
  • AML transformed from other myeloproliferative diseases.
  • Be accompanied with other progressing neoplasms.
  • With severe malfunction of liver, lungs, kidneys or heart: the plasma levels of direct bilirubin, indirect bilirubin, alanine transaminase, aspartate transaminase and serum creatinine all are 2 times higher than normal, cardiac function is above grade II.
  • With severe infection.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: IDA 8mg/M2
IDA 8mg/M2 per day, D1-3. iv injection in 10 minutes;Ara-C：100-200mg/M2 per day, D1-7. administration advice: at first, 25 mg/M2 of Ara-C is given by fast intravenous injection, then 100 mg/M2 of Ara-C is given by continuous iv drip for 24 hours for successive 7 days.
Drug: Idarubicin(8mg/m2) and cytosine arabinoside
IDA 8mg/M2 per day, D1-3. iv injection in 10 minutes;Ara-C：100-200mg/M2 per day, D1-7. administration advice: at first, 25 mg/M2 of Ara-C is given by fast intravenous injection, then 100 mg/M2 of Ara-C is given by continuous iv drip for 24 hours for successive 7 days.
Other Names:
  • Cytosine arabinoside
  • Safety
  • Idarubicin
  • Acute myeloid leukemia
  • Efficacy
Active Comparator: IDA 10mg/M2
IDA 10mg/M2 per day, D1-3. iv. injection in 10mimutes;Ara-C：100-200mg/M2 per day, D1-7. administration advice: at first, 25 mg/M2 of Ara-C is given by fast intravenous injection, then 100 mg/M2 of Ara-C is given by continuous iv drip for 24 hours for successive 7 days.
Drug: Idarubicin(10mg/m2), cytosine arabinoside
IDA 10mg/M2 per day, D1-3. iv. injection in 10mimutes;Ara-C：100-200mg/M2 per day, D1-7. administration advice: at first, 25 mg/M2 of Ara-C is given by fast intravenous injection, then 100 mg/M2 of Ara-C is given by continuous iv drip for 24 hours for successive 7 days.
Other Names:
  • Cytosine arabinoside
  • Safety
  • Idarubicin
  • Acute myeloid leukemia
  • Efficacy

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Overall survival(OS) and Disease free survival rate (DFS)
Time Frame: Within 5 years after randomization
Within 5 years after randomization

Secondary Outcome Measures

Outcome Measure
Time Frame
Induction remission rate
Time Frame: Within one month after induction therapy
Within one month after induction therapy

Other Outcome Measures

Outcome Measure
Time Frame
safety assessment (infection rate during induction therapy, liver and kidney toxicity, therapy related mortality, recovery time of blood count)
Time Frame: Randomization until death or two years post last subject last treatment visit (or clinical cutoff)
Randomization until death or two years post last subject last treatment visit (or clinical cutoff)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Guangdong Provincial People's Hospital

Investigators

  • Principal Investigator: Xin Du, MD.PhD, Guangdong Provincial People's Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

March 1, 2010

Primary Completion (Anticipated)

June 1, 2017

Study Completion (Anticipated)

June 1, 2017

Study Registration Dates

First Submitted

August 25, 2014

First Submitted That Met QC Criteria

October 27, 2014

First Posted (Estimate)

October 29, 2014

Study Record Updates

Last Update Posted (Estimate)

October 29, 2014

Last Update Submitted That Met QC Criteria

October 27, 2014

Last Verified

October 1, 2014

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • GDREC.[2010]017

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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