A study of effect of adding lenalidomide to standard chemotherapy and post-remission treatment in patients with newly diagnosed acute myeloid leukemia (AML) or high risk myelodysplasia (MDS)

• Conditions: previously untreated acute myeloid leukemia (AML) or high riskmyelodysplasie (MDS); MedDRA version: 17.1Level: LLTClassification code 10000886Term: Acute myeloid leukemiaSystem Organ Class: 100000004864; Therapeutic area: Diseases [C] - Blood and lymphatic diseases [C15]; MedDRA version: 17.1Level: LLTClassification code 10028532Term: MyelodysplasiaSystem Organ Class: 100000004864

• Registration Number: EUCTR2013-002843-26-FI
• Lead Sponsor: HOVON Foundation

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2015-03-12
• Last Update Posted: 10 July 2015

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: All
• Target Recruitment: 860

Inclusion Criteria

• Age 18-65 years, inclusive
• Patients with
o a diagnosis of AML and related precursor neoplasms according to
WHO 2008 classification (excluding acute promyelocytic leukemia)
including secondary AML (after an antecedent hematological disease
(e.g. MDS) and therapy-related AML), or
o acute leukemia's of ambiguous lineage according to WHO 2008 or
o a diagnosis of refractory anemia with excess of blasts (MDS) and
IPSS-R score > 4.5
• WHO performance status 0, 1 or 2
• Sampled bone marrow and/ blood cells at diagnosis for centralized
molecular analysis, MRD evaluation and biobanking, unless in case of a
dry marrow tap with no possibility to collect marrow cells. In cases of
marrow tap failure only blood cells will be sampled.
• Adequate renal and hepatic functions unless clearly disease related as
indicated by the following laboratory values:
o Serum creatinine =1.0 mg/dL (=88.7 µmol/L); if serum creatinine
>1.0 mg/dL (>88.7 µmol/L), then the estimated glomerular filtration
rate (GFR) must be >60 mL/min/1.73 m2 as calculated by the
Modification of Diet in Renal Disease equation where Predicted GFR
(ml/min/1.73 m2) = 186 x (Serum Creatinine in mg/dL)-1.154 x (age in
years)-0.203 x (0.742 if patient is female) x (1.212 if patient is black)
NOTE: if serum creatinine is measured in umol/L, recalculate it in
mg/dL according to the equation: 1 mg/dL = 88.7 umol/L) and use
above mentioned formula.
o Serum bilirubin =2.5 x upper limit of normal (ULN)
o Aspartate transaminase (AST) = 2.5 x ULN
o Alanine transaminase (ALT) = 2.5 x ULN
o Alkaline phosphatase = 2.5 x ULN
• Written informed consent
• Ability to adhere to the lenalidomide Pregnancy Prevention Program
Part B:
• CR or CRi
• Absolute neutrophil count (ANC) = 1.5 x 109/L
• Platelet count = 75 x 109/L
• Serum creatinine clearance = 30 ml/min
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 573
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 287

Exclusion Criteria

• Previous therapy with lenalidomide
• Acute promyelocytic leukemia
• Myeloproliferative neoplasia
• Previous treatment for AML or high risk MDS (IPSS-R > 4.5), except
hydroxyurea
• Concurrent history of active malignancy in two past years prior to
diagnosis except for:
o basal and squamous cell carcinoma of the skin
o in situ carcinoma of the cervix
• Concurrent severe and/or uncontrolled medical condition (e.g.
uncontrolled diabetes, infection, hypertension, pulmonary disease
etcetera)
• Cardiac dysfunction as defined by:
o Myocardial infarction within the last 6 months of study entry, or
o Reduced left ventricular function with an ejection fraction < 50% as
measured by MUG scan or echocardiogram or
o Unstable angina, or
o Unstable cardiac arrhythmias
• Pregnant or lactating females
• Unwilling or not capable to use effective means of birth control
• Any psychological, familial, sociological and geographical condition
potentially hampering compliance with the study protocol and follow-up
schedule
Part B:
• Severe cardiac dysfunction (NYHA classification II-IV, see appendix
G)
• Severe pulmonary dysfunction (CTCAE grade III-IV, see appendix F)
• Severe neurological or psychiatric disease
• Serious active infections
• Previous serious toxicities related to the use of lenalidomide
• CMV reactivation, which is not responsive to first line valganciclovir

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified