A randomized phase II multicenter study with a safety run-in to assess the tolerability and efficacy of the addition of oral lenalidomide to standard induction therapy in AML and RAEB ≥ 66 years and very poor risk AML ≥ 18 years.
Recruiting
- Conditions
- Acute Myeloid leukemia (AML), RAEB
- Registration Number
- NL-OMON25046
- Lead Sponsor
- HOVON foundation
- Brief Summary
/A
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- Not specified
- Target Recruitment
- 200
Inclusion Criteria
1. Patients eligible for standard chemotherapy;
2. Patients ≥ 66 years with a cytopathologically confirmed diagnosis according WHO classification of:
Exclusion Criteria
1. Acute promyelocytic leukemia;
2. Patients previously treated for AML (any antileukemic therapy including investigational agents)- a short treatment period (< 2 weeks) with Hydroxyurea is allowed;
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Part A of the study (if applicable):<br /><br>1. To assess the safety and tolerability of lenalidomide added to standard induction chemotherapy for AML (frequency and severity of toxicities and the durations of neutropenia and thrombocytopenia) and select the feasible dose level for part B of the study;<br /><br>2. To assess in a randomized comparison the effect of lenalidomide on the CR rate.<br /><br>Part B of the study:<br /><br>1. To assess the safety and tolerability of lenalidomide added to standard induction chemotherapy for AML (frequency and severity of toxicities and the durations of neutropenia and thrombocytopenia) as regards the selected dose level of lenalidomide;<br /><br>2. To assess in a randomized comparison the effect of the in Part A selected dose of lenalidomide on the CR rate.
- Secondary Outcome Measures
Name Time Method For part B:<br /><br>1. To determine the efficacy profile (event free survival (EFS), disease free survival (DFS) and overall survival (OS)) associated with the two therapy regimens;<br /><br>2. To measure MRD by immunophenotyping in relation to clinical response parameters;<br /><br>3. To identify potential biomarkers predictive of response, EFS, DFS and OS by exploratory genomic analysis (microarray, gene mutations).