Randomised induction and post induction therapy in older patients (>=61 years of age) with acute myeloid leukaemia (AML) and refractory anaemia with excess blasts (RAEB, RAEB-t) - HOVON 43
- Conditions
- Acute Myeloid Leukaemia (AML)Refractory Anaemia with Excesss Blasts (RAEB)
- Registration Number
- EUCTR2004-001918-13-GB
- Lead Sponsor
- niversity of Wales College of Medicine
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Authorised-recruitment may be ongoing or finished
- Sex
- All
- Target Recruitment
- 800
Inclusion Criteria
- age 61 years or over
- WHO performance score < 3
- informed consent
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range
Exclusion Criteria
- impaired renal or hepatic function
-previous chemotherapy
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Secondary Objective: Secondary objectives<br>-effect of daunorubicin dose in induction will be evaluated as regards complete remission rate, overall survival and toxicity.<br>-gemtuzumab ozogamicin therapy post remission will be evaluated with respect to toxicity, probability of relapse and probability of death in first CR and overall survival<br>-evaulate prognostic factors (eg, CD33 positivity, MDR phenotype, cytogenetics) in the context of these induction and post remission therapies as regards complete response probability, overall survival, event free survival, disease free survival ;Main Objective: Main objectives: <br>-Evaluation of the effect of an escalated dose of Daunorubincin in induction treatment<br>-Evaluation of the effect of maintenance treatment with GO for patients in CR;Primary end point(s): - complete remission rate<br>- death
- Secondary Outcome Measures
Name Time Method