A study for the treatment of patients with leukemic cells in their bone marrow.

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. A study in the frame of the masterprotocol of parallel randomized phase II studies in elderly AML - HOVON 103 AML Lenalidomide

Status

Active, not recruiting

Phases

Phase 2

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2009-013094-17-BE

Enrollment

240

Registered

2010-05-27

Start date

2010-12-02

Completion date

Unknown

Last updated

2025-01-27

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

Conditions

patients = 66 years.with a confirmed diagnosis of o AML (not APL) (see appendix A) or o refractory anemia with excess of blasts (RAEB) with an IPSS score = 1.5 OR Patients of any age = 18 years with a confirmed diagnosis of o AML with very poor risk AML MedDRA version: 14.1 Level: LLT Classification code 10000886 Term: Acute myeloid leukemia System Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps) MedDRA version: 14.1 Level: LLT Classifi

Interventions

Trade Name: Revlimid, 5 mg capsule Product Name: Revlimid Pharmaceutical Form: Capsule, hard INN or Proposed INN: LENALIDOMIDE CAS Number: 191732-72-6 Current Sponsor code: RV 0428 Other descriptive n

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: - Patients eligible for standard chemotherapy. - Patients = 66 years.with a cytopathologically confirmed diagnosis according WHO classification of o AML (not APL) (see appendix A) or o refractory anemia with excess of blasts (RAEB) with an IPSS score = 1.5 OR - Patients of any age = 18 years with cytopathologically confirmed diagnosis according WHO classification of o AML with very poor risk AML - Subjects with secondary AML progressing from antecedent (at least 4 months duration) myelodysplasia are also eligible. - SGOT (AST) and SGPT (ALT) =65 years) yes F.1.3.1 Number of subjects for this age range 230

Exclusion criteria

Exclusion criteria: -Acute promyelocytic leukemia - Patients previously treated for AML (any antileukemic therapy including investigational agents), a short treatment period (< 2 weeks) with Hydroxyurea is allowed - Past or current history (within the last 2 years prior to randomization) of malignancies except for the indication under this study and curatively treated: - Basal and squamous cell carcinoma of the skin - in situ carcinoma of the cervix - Blast crisis of chronic myeloid leukemia - Clinically significant (i.e. active) cardiovascular disease, for example cerebrovascular accidents (= 6 months prior to randomization), myocardial infarction (= 6 months prior to randomization), unstable angina, New York Heart Association (NYHA) grade II or greater congestive heart failure, - Patients with a history of non-compliance to medical regimens or who are considered unreliable with respect to compliance - Patients with any serious concomitant medical condition which could, in the opinion of the investigator, compromise participation in the study. - Patients who have senile dementia, mental impairment or any other psychiatric disorder that prohibits the patient from understanding and giving informed consent. - Pregnant or lactating patients. - Current concomitant chemotherapy, radiation therapy, or immunotherapy other than as specified in the protocol.

Design outcomes

Primary

Measure	Time frame
Main Objective: For part A of the study (if applicable): 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 2.To assess in a randomized comparison the effect of lenalidomide on the CR rate. For part B: 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 2.To assess in a randomized comparison the effect of lenalidomide on the CR rate. ;Secondary Objective: For part B: 1.To determine the efficacy profile (event free survival and disease free survival and overall survival) associated with the two therapy regimens. 2.To measure MRD by immunophenotyping in relation to clinical response parameters. 3.To identify potential biomarkers predictive of response, event free survival and disease free survival by exploratory proteomic and genomic analysis (microarray, gene mutations) ;Primary end point(s): - Incidence of DLT (part A) - The effect of lenalidomide on the CR rate (part B of study) ;Timepoint(s) of evaluation of this end point: The final analysis of the primary endpoints will be done one year after last patient is registered in the lenalidomide arm.	—

Measure

Time frame

Main Objective: For part A of the study (if applicable): 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 2.To assess in a randomized comparison the effect of lenalidomide on the CR rate. For part B: 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 2.To assess in a randomized comparison the effect of lenalidomide on the CR rate. ;Secondary Objective: For part B: 1.To determine the efficacy profile (event free survival and disease free survival and overall survival) associated with the two therapy regimens. 2.To measure MRD by immunophenotyping in relation to clinical response parameters. 3.To identify potential biomarkers predictive of response, event free survival and disease free survival by exploratory proteomic and genomic analysis (microarray, gene mutations) ;Primary end point(s): - Incidence of DLT (part A) - The effect of lenalidomide on the CR rate (part B of study) ;Timepoint(s) of evaluation of this end point: The final analysis of the primary endpoints will be done one year after last patient is registered in the lenalidomide arm.

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Secondary

Measure	Time frame
Secondary end point(s): 1. To determine the efficacy profile (event free survival (EFS) disease free survival (DFS) and overall survival (OS)) associated with the two therapy regimens. 2. To measure MRD by immunophenotyping in relation to clinical response parameters. 3. To identify potential biomarkers predictive of response, EFS, DFS and OS by exploratory genomic analysis (microarray, gene mutations);Timepoint(s) of evaluation of this end point: The final analysis of the secondary endpoints will be done one year after last patient is registered in the lenalidomide arm.	—

Measure

Time frame

Secondary end point(s): 1. To determine the efficacy profile (event free survival (EFS) disease free survival (DFS) and overall survival (OS)) associated with the two therapy regimens. 2. To measure MRD by immunophenotyping in relation to clinical response parameters. 3. To identify potential biomarkers predictive of response, EFS, DFS and OS by exploratory genomic analysis (microarray, gene mutations);Timepoint(s) of evaluation of this end point: The final analysis of the secondary endpoints will be done one year after last patient is registered in the lenalidomide arm.

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Countries

Belgium, Netherlands, Norway, Switzerland

Contacts

Public ContactHOVON Data Center

Erasmus MC

hdc@erasmusmc.nl+31(0)107041560

Outcome results

None listed

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