Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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TERMINATED
PHASE1
14 participants
INTERVENTIONAL
2009-01-31
2011-05-31
Brief Summary
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Detailed Description
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Conditions
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Keywords
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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Lenalidomide
lenalidomide
Dose escalation:
Level 0 to level 5, starting with level 1 = 25mg lenalidomide per os daily, Cohorts of 3 patients (to be expanded up to 6 if 1 DLT is observed among the first 3 patients) will be sequentially allotted to progressively higher dose levels of lenalidomide on the basis of the presence and severity of lenalidomide related toxicity encountered in the first cycle or lenalidomide related serious adverse reactions.
Duration of the first cycle: 56days, each following cycle will last 28 days
Interventions
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lenalidomide
Dose escalation:
Level 0 to level 5, starting with level 1 = 25mg lenalidomide per os daily, Cohorts of 3 patients (to be expanded up to 6 if 1 DLT is observed among the first 3 patients) will be sequentially allotted to progressively higher dose levels of lenalidomide on the basis of the presence and severity of lenalidomide related toxicity encountered in the first cycle or lenalidomide related serious adverse reactions.
Duration of the first cycle: 56days, each following cycle will last 28 days
Eligibility Criteria
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Inclusion Criteria
* Age \> 70 years newly diagnosed AML (including de novo, s-AML, t-AML)considered ineligible for intensive treatment. Ineligibility for intensive treatment has to be documented within the case report forms (Medical/Oncologic History).
* Age \> 60 years relapsed/refractory AML in medically fit patients and newly diagnosed AML (including de novo, s- AML,t-AML) in medically unfit patients
* Age 18-60 years: second or higher relapse of AML, not eligible for intensive therapy
* WBC \<20x109/l, pretreatment with hydroxyurea is allowed to lower WBC
* Prior chemo-immunotherapy and other study-medications must have been completed 2 weeks before study treatment start. Treatment with hydroxyureas should be discontinued 1 day before initiating dosing with lenalidomide
* Willingness and ability to comply with scheduled visits,treatment plan, laboratory tests and other study procedures
* Females of childbearing potential (FCBP)† must agree to use two reliable forms of contraception simultaneously or to practice complete abstinence from - FCBP must have two negative pregnancy tests (sensitivity of at least 50 mIU/mL) prior to starting study drug.
* Male subjects must agree to use a latex condom during sexual contact with females of childbearing potential while participating in the study and for at least 28 days following discontinuation from the study even if he has undergone a successful vasectomy.
Exclusion Criteria
* bleeding disorder independent of the AML
* uncontrolled infection
* insufficiency of the kidneys (creatinin \>1.5x upper normal serum level), of the liver (bilirubin, AST or AP \> 2x upper normal serum level)
* severe obstructive or restrictive ventilation disorder
* heart failure NYHA III/IV
* severe neurological or psychiatric disorder interfering with ability of giving an informed consent
* no consent for registration, storage and processing of the individual disease-characteristics and course
* peripheral neuropathy
* Performance status WHO \> 2
* Presence of any medical/psychiatric condition or laboratory abnormalities which may limit full compliance with the study, increase the risk associated with study participation or study drug administration, or may interfere with the interpretation of study results and, in the judgment of the Investigator, would make the patient inappropriate for entry into this study
* Pregnancy or breast-feeding
* Known positive for HIV or infectious hepatitis, type A, B or C
* Known hypersensitivity to thalidomide
* Any prior use of lenalidomide
* Drug or alcohol abuse within the last 6 months
* Participating in other studies within the last 2 weeks
18 Years
ALL
No
Sponsors
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University of Ulm
OTHER
Responsible Party
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University of Ulm
Principal Investigators
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Richard Schlenk, MD
Role: PRINCIPAL_INVESTIGATOR
University Hospital of Ulm
Locations
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University Hospital of Bonn
Bonn, , Germany
University Hospital of Düsseldorf
Düsseldorf, , Germany
Hospital of the Johann Wolfgang Goethe University
Frankfurt, , Germany
University Hospital of Hamburg Eppendorf
Hamburg, , Germany
Medizinische Hochschule Hannover
Hanover, , Germany
University Hospital of Ulm
Ulm, , Germany
Countries
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Related Links
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Related Info
Other Identifiers
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AMLSG08-07
Identifier Type: -
Identifier Source: org_study_id