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

Status

Not yet recruiting

Phases

Unknown

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2004-001918-13-GB

Enrollment

800

Registered

2005-07-25

Start date

2008-01-17

Completion date

Unknown

Last updated

2012-03-19

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Acute Myeloid Leukaemia (AML) Refractory Anaemia with Excesss Blasts (RAEB)

Interventions

Trade Name: Mylotarg Product Name: Mylotarg Pharmaceutical Form: Powder for solution for injection Trade Name: Daunorubicin Product Name: Daunorubicin Pharmaceutical Form: Intravenous infusion

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: - age 61 years or over - WHO performance score =65 years) yes F.1.3.1 Number of subjects for this age range

Exclusion criteria

Exclusion criteria: - impaired renal or hepatic function -previous chemotherapy

Design outcomes

Primary

Measure	Time frame
Secondary Objective: Secondary objectives -effect of daunorubicin dose in induction will be evaluated as regards complete remission rate, overall survival and toxicity. -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 -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: -Evaluation of the effect of an escalated dose of Daunorubincin in induction treatment -Evaluation of the effect of maintenance treatment with GO for patients in CR;Primary end point(s): - complete remission rate - death	—

Measure

Time frame

Secondary Objective: Secondary objectives -effect of daunorubicin dose in induction will be evaluated as regards complete remission rate, overall survival and toxicity. -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 -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: -Evaluation of the effect of an escalated dose of Daunorubincin in induction treatment -Evaluation of the effect of maintenance treatment with GO for patients in CR;Primary end point(s): - complete remission rate - death

—

Countries

United Kingdom

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026