Acute myeloid leukaemia (AML) trial 12 (protocol for children)

Completed

• Conditions: eukaemia; Cancer; Leukaemia

• Registration Number: ISRCTN64649191
• Lead Sponsor: Medical Research Council (MRC) (UK)

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2000-10-25
• Last Update Posted: 13 January 2015

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 2000

Inclusion Criteria

1. They have one of the types of acute myeloid leukaemia (de novo or secondary)
2. They have aggressive myelodysplastic syndrome (MDS) (Refractory anemia with excess blasts [RAEB], Refractory anemia with excess blasts in transformation [RAEB-t]) for whom AML-type therapy is considered appropriate
3. They are considered suitable for intensive chemotherapy
4. They are under 16 years and if the patients/parents have given informed consent

Exclusion Criteria

1. Patients who have previously received cytotoxic chemotherapy for leukaemia;
2. They are in blast transformation of chronic myeloid leukaemia;
3. They have a concurrent active malignancy or the physician and patient/parents consider that intensive therapy is not an appropriate option.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Achievement and duration of remission, survival, febrile incidents, toxicity including cardiotoxicity, supportive care requirements and long-term outcome.

Secondary Outcome Measures

Name	Time	Method
ot provided at time of registration