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

• Status: Unknown status
• Trial end date: 2017-06-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Guangdong General Hospital; Guangdong Provincial People's Hospital
• Treatments: Cytarabine; Idarubicin

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.