Lenalidomide In Patients With Acute Myeloid Leukemia

This study has been terminated.
(Results of an interim analysis and a hardly ongoing enrolment in the last 10 months in all six participating centres)
Sponsor:
Information provided by:
University of Ulm
ClinicalTrials.gov Identifier:
NCT00839059
First received: January 20, 2009
Last updated: July 28, 2011
Last verified: July 2011
  Purpose

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.


Condition Intervention Phase
Acute Myeloid Leukemia
Drug: lenalidomide
Phase 1

Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Open-Label, Multi-Center Phase I Dose-Escalation Study With Lenalidomide In Patients With Acute Myeloid Leukemia

Resource links provided by NLM:


Further study details as provided by University of Ulm:

Primary Outcome Measures:
  • Dose-Limiting Toxicities (DLTs), Maximum tolerated dose (MTD) [ Time Frame: 1-56 days ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Measurement of the pharmacokinetic profile of lenalidomide [ Time Frame: 1st and 8th day ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]

Enrollment: 14
Study Start Date: January 2009
Study Completion Date: May 2011
Primary Completion Date: May 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Lenalidomide Drug: 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

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00839059

Locations
Germany
University Hospital of Bonn
Bonn, Germany, 53111
University Hospital of Düsseldorf
Düsseldorf, Germany, 40225
Hospital of the Johann Wolfgang Goethe University
Frankfurt, Germany, 60596
University Hospital of Hamburg Eppendorf
Hamburg, Germany, 20246
Medizinische Hochschule Hannover
Hannover, Germany, 30625
University Hospital of Ulm
Ulm, Germany, 89081
Sponsors and Collaborators
University of Ulm
Investigators
Principal Investigator: Richard Schlenk, MD University Hospital of Ulm
  More Information

Additional Information:
No publications provided

Responsible Party: Prof. Dr. Reinhard Marre, University of Ulm
ClinicalTrials.gov Identifier: NCT00839059     History of Changes
Other Study ID Numbers: AMLSG08-07
Study First Received: January 20, 2009
Last Updated: July 28, 2011
Health Authority: Germany: Federal Institute for Drugs and Medical Devices

Keywords provided by University of Ulm:
AML
lenalidomide

Additional relevant MeSH terms:
Leukemia, Myeloid
Leukemia, Myeloid, Acute
Leukemia
Neoplasms by Histologic Type
Neoplasms
Lenalidomide
Thalidomide
Immunologic Factors
Physiological Effects of Drugs
Pharmacologic Actions
Angiogenesis Inhibitors
Angiogenesis Modulating Agents
Growth Substances
Growth Inhibitors
Antineoplastic Agents
Therapeutic Uses
Immunosuppressive Agents
Leprostatic Agents
Anti-Bacterial Agents
Anti-Infective Agents

ClinicalTrials.gov processed this record on September 18, 2014