Randomised induction and post-induction therapy in adult patients (less than or equal to 60 years of age) with acute myelocytic leukaemia (AML) or refractory anaemia with excess of blasts (RAEB, RAEB-t) with IPSS score greater than or equal to 1.5

Completed

• Conditions: Acute myeloid leukaemia (AML); Cancer; Myeloid leukaemia

• Registration Number: ISRCTN38648181
• Lead Sponsor: Dutch Haemato-Oncology Association (Stichting Hemato-Oncologie Volwassenen Nederland) (HOVON) (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: 800

Inclusion Criteria

1. Aged 18 - 60 years (inclusive)
2. Subjects with a cytopathologically confirmed diagnosis of:
2.1. AML (M0-M2 and M4-M7, FAB classification), or
2.2. With refractory anaemia with excess of blasts (RAEB) or refractory anaemia with excess of blasts in transformation (RAEB-t) with an IPSS score of greater than or equal to 1.5
3. Patients with therapy-related AML/RAEB/RAEB-t are eligible provided they have not received chemotherapy during the past 6 months. Also patients with biphenotypic leukemia may be included.
4. Subjects with a secondary AML progressing from antecedent myelodysplasia are eligible. Antecedent MDS refers to a condition of at least 4 month duration
5. World Health Organization (WHO) performance status less than or equal to 2
6. Written informed consent

Exclusion Criteria

1. Prior chemotherapy within 6 months of study entry
2. Relapse of AML or MDS after induction chemotherapy
3. Prior stem cell transplant
4. Previous polycythemia rubra vera
5. Primary myelofibrosis
6. Blast crisis of chronic myeloid leukemia
7. AML-FAB type M3 or AML with cytogenetic abnormality t(1517) or AML with a PML/RAR alpha or a variant RAR alpha fusion gene
8. Impaired hepatic or renal function as defined by: alanine aminotransferase (ALT) and/or aspartate aminotransferase (AST) greater than 3 x normal value, bilirubin greater than 3 x normal value, serum creatinine greater than 3 x normal value (after adequate hydration), (unless these are most likely caused by AML organ infiltration)
9. Concurrent severe and/or uncontrolled medical condition (e.g. uncontrolled diabetes, infection, hypertension, etc)
10. Cardiac dysfunction as defined by: myocardial infarction within the last 6 months of study entry, or reduced left ventricular function with an ejection fraction less than or equal to 50% as measured by MUGA scan or echocardiogram (another method for measuring cardiac function is acceptable), unstable angina, unstable cardiac arrhythmias
11. Pregnancy

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
1. Endpoint for the comparison of induction treatment arm B with arm A and for the comparison yes or no G-CSF priming: Event-free survival (i.e., time from registration to induction failure, death or relapse whichever occurs first); the time to failure of patients with induction failure is set at one day.<br>2. Endpoint for the comparison of PBSCT with cycle III: Disease-free survival measured from the date of second randomisation to relapse or death from any cause.<br>3. Endpoint for the evaluation of Allo-SCT: Disease-free survival measured from the date of Allo-SCT to relapse or death from any cause.