Clinical trial NCT00839059: 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
Overall status: TERMINATED
Phase: PHASE1
Conditions: Acute Myeloid Leukemia
Keywords: AML
lenalidomide
Lead sponsor: University of Ulm
Sponsor class: OTHER
First posted: 2009-02-09
Enrollment: 14
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.


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

Primary outcomes:
measure: Dose-Limiting Toxicities (DLTs), Maximum tolerated dose (MTD)
timeFrame: 1-56 days
Secondary outcomes:
measure: Measurement of the pharmacokinetic profile of lenalidomide
timeFrame: 1st and 8th day
measure: 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
timeFrame: 1 year
Other outcomes:
Locations:
city: Bonn
country: Germany
facility: University Hospital of Bonn
city: Düsseldorf
country: Germany
facility: University Hospital of Düsseldorf
city: Frankfurt
country: Germany
facility: Hospital of the Johann Wolfgang Goethe University
city: Hamburg
country: Germany
facility: University Hospital of Hamburg Eppendorf
city: Hannover
country: Germany
facility: Medizinische Hochschule Hannover
city: Ulm
country: Germany
facility: University Hospital of Ulm
Study officials:
affiliation: University Hospital of Ulm
name: Richard Schlenk, MD
role: PRINCIPAL_INVESTIGATOR
References: