Lenalidomide In Patients With Acute Myeloid Leukemia
Primary Purpose
Acute Myeloid Leukemia
Status
Terminated
Phase
Phase 1
Locations
Germany
Study Type
Interventional
Intervention
lenalidomide
Sponsored by
About this trial
This is an interventional treatment trial for Acute Myeloid Leukemia focused on measuring AML, lenalidomide
Eligibility Criteria
Inclusion Criteria:
Disease state:
- 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:
- Acute promyelocytic leukemia [t(15;17)]
- 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
Sites / Locations
- University Hospital of Bonn
- University Hospital of Düsseldorf
- Hospital of the Johann Wolfgang Goethe University
- University Hospital of Hamburg Eppendorf
- Medizinische Hochschule Hannover
- University Hospital of Ulm
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Lenalidomide
Arm Description
Outcomes
Primary Outcome Measures
Dose-Limiting Toxicities (DLTs), Maximum tolerated dose (MTD)
Secondary Outcome Measures
Measurement of the pharmacokinetic profile of lenalidomide
Objective tumor response, as defined using the revised recommendations of the International Working Group for diagnosis, standardization of response criteria in Acute Myeloid Leukemia for AML
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT00839059
Brief Title
Lenalidomide In Patients With Acute Myeloid Leukemia
Official Title
Open-Label, Multi-Center Phase I Dose-Escalation Study With Lenalidomide In Patients With Acute Myeloid Leukemia
Study Type
Interventional
2. Study Status
Record Verification Date
July 2011
Overall Recruitment Status
Terminated
Why Stopped
Results of an interim analysis and a hardly ongoing enrolment in the last 10 months in all six participating centres
Study Start Date
January 2009 (undefined)
Primary Completion Date
May 2011 (Actual)
Study Completion Date
May 2011 (Actual)
3. Sponsor/Collaborators
Name of the Sponsor
University of Ulm
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
This is a Phase I, open-label, multi-center, dose-escalation study of lenalidomide in adult patients with newly diagnosed, relapsed or refractory acute myeloid leukemia. All patients will receive lenalidomide per oral daily (starting dose is 25 mg/d). Cohorts of 3 patients (to be expanded up to 6 if 1 dose-limiting toxicity (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 or lenalidomide related serious adverse reactions encountered in the first cycle. For the purpose of this study, patients' enrollment will continue until the maximum tolerated dose (MTD) will be determined and characterized.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Acute Myeloid Leukemia
Keywords
AML, lenalidomide
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
14 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Lenalidomide
Arm Type
Experimental
Intervention Type
Drug
Intervention Name(s)
lenalidomide
Intervention Description
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
Primary Outcome Measure Information:
Title
Dose-Limiting Toxicities (DLTs), Maximum tolerated dose (MTD)
Time Frame
1-56 days
Secondary Outcome Measure Information:
Title
Measurement of the pharmacokinetic profile of lenalidomide
Time Frame
1st and 8th day
Title
Objective tumor response, as defined using the revised recommendations of the International Working Group for diagnosis, standardization of response criteria in Acute Myeloid Leukemia for AML
Time Frame
1 year
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Disease state:
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:
Acute promyelocytic leukemia [t(15;17)]
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Richard Schlenk, MD
Organizational Affiliation
University Hospital of Ulm
Official's Role
Principal Investigator
Facility Information:
Facility Name
University Hospital of Bonn
City
Bonn
ZIP/Postal Code
53111
Country
Germany
Facility Name
University Hospital of Düsseldorf
City
Düsseldorf
ZIP/Postal Code
40225
Country
Germany
Facility Name
Hospital of the Johann Wolfgang Goethe University
City
Frankfurt
ZIP/Postal Code
60596
Country
Germany
Facility Name
University Hospital of Hamburg Eppendorf
City
Hamburg
ZIP/Postal Code
20246
Country
Germany
Facility Name
Medizinische Hochschule Hannover
City
Hannover
ZIP/Postal Code
30625
Country
Germany
Facility Name
University Hospital of Ulm
City
Ulm
ZIP/Postal Code
89081
Country
Germany
12. IPD Sharing Statement
Links:
URL
http://www.kompetenznetz-leukaemie.de
Description
Related Info
Learn more about this trial
Lenalidomide In Patients With Acute Myeloid Leukemia
We'll reach out to this number within 24 hrs