Acute Myeloid Leukaemia - High Risk (AML-HR)

Not Applicable

Completed

• Conditions: Cancer; Leukaemia; eukaemia

• Registration Number: ISRCTN88373119
• Lead Sponsor: Medical Research Council (MRC) (UK)

Brief Summary

Results on http://www.ncbi.nlm.nih.gov/entrez/query.fcgi?db=pubmed&cmd=Retrieve&dopt=Abstract&list_uids=16484584

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2000-10-25
• Study Completion: 2004-12-31
• Last Update Posted: 12 November 2018

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 600

Inclusion Criteria

1. High risk acute myeloid leukaemia (AML) (de novo or secondary, except acute promyelocytic leukemia [APL])
2. Suitable for intensive therapy
3. Informed consent given. High risk AML is defined as:
(a) Resistant disease (greater than 15% blasts in bone marrow) after one induction course
(b) Refractory disease (ie not in complete remission [CR]) after two or more induction courses
(c) Relapse from first CR (with more than 5% blasts in bone marrow)
(d) In complete or partial remission after one induction course but with adverse cytogenic abnormalities at diagnosis

Exclusion Criteria

1. APL
2. Concurrent active malignancy
3. Blast transformation of CML
4. Relapse from second or greater CR
5. Severe renal impairment (creatinine clearance less than 30 millilitres per minute)
6. Pregnant, lactating or potentially fertile and not taking adequate contraceptive precautions

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
1. Survival<br>2. Complete remission (CR) rates and reason for failure<br>3. Duration of remission<br>4. Toxicity<br>5. Quality of life<br>5. Supportive care requirements

Secondary Outcome Measures

Name	Time	Method
ot provided at time of registration