Lenalidomide In Patients With Acute Myeloid Leukemia

July 28, 2011 updated by: University of Ulm

Open-Label, Multi-Center Phase I Dose-Escalation Study With Lenalidomide In Patients With Acute Myeloid Leukemia

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.

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

14

Phase

  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Germany
      • Bonn, Germany, 53111
        • University Hospital of Bonn
      • Düsseldorf, Germany, 40225
        • University Hospital of Düsseldorf
      • Frankfurt, Germany, 60596
        • Hospital of the Johann Wolfgang Goethe University
      • Hamburg, Germany, 20246
        • University Hospital of Hamburg Eppendorf
      • Hannover, Germany, 30625
        • Medizinische Hochschule Hannover
      • Ulm, Germany, 89081
        • University Hospital of Ulm

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Dose-Limiting Toxicities (DLTs), Maximum tolerated dose (MTD)
Time Frame: 1-56 days
1-56 days

Secondary Outcome Measures

Outcome Measure
Time Frame
Measurement of the pharmacokinetic profile of lenalidomide
Time Frame: 1st and 8th day
1st and 8th day
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
1 year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Ulm

Investigators

  • Principal Investigator: Richard Schlenk, MD, University Hospital of Ulm

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2009

Primary Completion (Actual)

May 1, 2011

Study Completion (Actual)

May 1, 2011

Study Registration Dates

First Submitted

January 20, 2009

First Submitted That Met QC Criteria

February 6, 2009

First Posted (Estimate)

February 9, 2009

Study Record Updates

Last Update Posted (Estimate)

July 29, 2011

Last Update Submitted That Met QC Criteria

July 28, 2011

Last Verified

July 1, 2011

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • AMLSG08-07

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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