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Trial record 28 of 253 for:    IDARUBICIN

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

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ClinicalTrials.gov Identifier: NCT02277847
Recruitment Status : Unknown
Verified October 2014 by Guangdong General Hospital.
Recruitment status was:  Enrolling by invitation
First Posted : October 29, 2014
Last Update Posted : October 29, 2014
Sponsor:
Information provided by (Responsible Party):
Guangdong General Hospital

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Acute Myeloid Leukemia Drug: Idarubicin(8mg/m2) and cytosine arabinoside Drug: Idarubicin(10mg/m2), cytosine arabinoside Phase 4

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  (Clinical Trial)
Estimated Enrollment : 400 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: 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 Start Date : March 2010
Estimated Primary Completion Date : June 2017
Estimated Study Completion Date : June 2017


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:
  • Idarubicin
  • Cytosine arabinoside
  • Acute myeloid leukemia
  • Safety
  • 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:
  • Idarubicin
  • Cytosine arabinoside
  • Acute myeloid leukemia
  • Safety
  • Efficacy




Primary Outcome Measures :
  1. Overall survival(OS) and Disease free survival rate (DFS) [ Time Frame: Within 5 years after randomization ]

Secondary Outcome Measures :
  1. Induction remission rate [ Time Frame: Within one month after induction therapy ]

Other Outcome Measures:
  1. 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) ]


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Ages Eligible for Study:   14 Years to 60 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02277847


Sponsors and Collaborators
Guangdong General Hospital
Investigators
Principal Investigator: Xin Du, MD.PhD Guangdong General Hospital

Publications of Results:

Responsible Party: Guangdong General Hospital
ClinicalTrials.gov Identifier: NCT02277847     History of Changes
Other Study ID Numbers: GDREC.[2010]017
First Posted: October 29, 2014    Key Record Dates
Last Update Posted: October 29, 2014
Last Verified: October 2014

Keywords provided by Guangdong General Hospital:
Idarubicin
Cytosine arabinoside
Efficacy
Safety

Additional relevant MeSH terms:
Idarubicin
Leukemia
Leukemia, Myeloid
Leukemia, Myeloid, Acute
Neoplasms by Histologic Type
Neoplasms
Cytarabine
Antibiotics, Antineoplastic
Antineoplastic Agents
Topoisomerase II Inhibitors
Topoisomerase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Antimetabolites, Antineoplastic
Antimetabolites
Antiviral Agents
Anti-Infective Agents
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs