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

NCT02277847 · Status: UNKNOWN · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 400

Last updated 2014-10-29

No results posted yet for this study

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.

Conditions

Interventions

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.

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.

Sponsors & Collaborators

  • Guangdong Provincial People's Hospital

    lead OTHER

Principal Investigators

  • Xin Du, MD.PhD · Guangdong Provincial People's Hospital

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

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

Timeline & Regulatory

Start
2010-03-31
Primary Completion
2017-06-30
Completion
2017-06-30

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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 NCT02277847 on ClinicalTrials.gov