TRIAL Relapsed AML 2001/01: a randomised phase III study on the treatment of children and adolescents with refractory or relapsed acute myeloid leukaemia (AML)

Completed

• Conditions: Acute myeloid leukaemia; Cancer; Myeloid leukaemia

• Registration Number: ISRCTN94206677
• Lead Sponsor: Dutch Childhood Oncology Group (Stichting Kinder Oncologie [SKION]) (The Netherlands)

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2005-12-20
• Last Update Posted: 13 January 2015

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 400

Inclusion Criteria

1. Primary refractory acutye myeloid leukaemia (AML)
2. First relapsed AML
3. Second or subsequent relapsed AML, but not previously treated according to protocol Relapsed AML 2001/01
4. Below 18 years of age at initial diagnosis
5. Signed informed consent

Exclusion Criteria

1. Symptomatic cardiac dysfunction (CTC grade 3 or 4), and/or a fractional shortening at echocardiography below 29%
2. Karnofsky performance status less than 40% (children aged 16 years and older) or Lansky performance status of less than 40% (younger children)
3. Any other organ dysfunction (CTC grade 4) that will interfere with the protocol treatment
4. Inability to apply to the protocol for other reasons
5. AML FAB type M3, acute promyelocytic leukaemia, and/or t(1517) and/or PML-RARalfa fusion gene

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Percentage of BM blasts greater than 20% after course I, determined 4 - 6 weeks after the start.

Secondary Outcome Measures

Name	Time	Method
1. Toxicity, focusing on but not limited to bone marrow aplasia, mucosal toxicity and cardiotoxicity<br>2. Efficacy as determined by day 14 BM blasts, time to PB clearance of blasts, CR rate after two courses of chemotherapy, % of patients that underwent SCT, overall survival, event-free survival and disease-free survival<br>3. Clinical and cell biological features, and overall outcome of the entire cohort of patients with relapsed AML that has been registered in the time period of patient accrual (also including patients that were not treated according to this protocol)