Status:
UNKNOWN
Idarubicin at Different Dosages as Induction Therapy for Newly Diagnosed Acute Myeloid Leukaemia
Lead Sponsor:
Guangdong Provincial People's Hospital
Conditions:
Acute Myeloid Leukemia
Eligibility:
All Genders
14-60 years
Phase:
PHASE4
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 ...
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 ba...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
March 1 2010
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
June 1 2017
Estimated Enrollment :
400 Patients enrolled
Trial Details
Trial ID
NCT02277847
Start Date
March 1 2010
End Date
June 1 2017
Last Update
October 29 2014
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