Lenalidomide in Patients With Chronic Myelomonocytic Leukemia

March 6, 2015 updated by: Arbeitsgemeinschaft medikamentoese Tumortherapie

A Phase I/II Study of Lenalidomide in Patients With Chronic Myelomonocytic Leukemia

In a phase I study the investigators plan to investigate safety and toxicity of lenalidomide in patients with Chronic Myelomonocytic Leukemia (CMML). A phase II study will be started once an optimal dose has been found. The primary endpoint will concern the efficacy of lenalidomide in patients with CMML according to the WHO diagnostic criteria.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

30

Phase

  • Phase 2
  • 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

  • Austria
      • Salzburg, Austria, 5020
        • Universitaetsklinik der PMU Salzburg, UK f. Innere Medizin III
      • Wien, Austria, 1090
        • MUW/ AKH Wien Univ. Klinik für Innere Medizin I, Abteilung für Hämatologie und Hämostaseologie
      • Wien, Austria, 1140
        • Hanusch Krankenhaus, 3. Med. Abtlg. Für Hämatologie und Onkologie
    • Oberösterreich
      • Linz, Oberösterreich, Austria, 4010
        • Krankenhaus d. Barmherzigen Schwestern Linz, Interne I
      • Linz, Oberösterreich, Austria, 4010
        • Krankenhaus der Elisabethinen Linz GmbH, 1. Interne
      • Linz, Oberösterreich, Austria, 4021
        • AKH Linz, Innere Medizin 3, Zentrum für Hämatologie und medizinische Onkologie
      • Wels, Oberösterreich, Austria, 4600
        • Klinikum Wels-Grieskirchen GmbH, IV. Interne Abteilung
    • Steiermark
      • Graz, Steiermark, Austria, 8036
        • Universitätsklinik f. Innere Medizin Graz, Klinische Abteilung f. Hämatologie
    • Tirol
      • Innsbruck, Tirol, Austria, 6020
        • Universitätsklinik für Innere Medizin Innsbruck, Klinische Abteilung für Hämatologie und Onkologie
    • Vorarlberg
      • Feldkirch, Vorarlberg, Austria, 6807
        • LKH Feldkirch, Interne E

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:

  1. CMML according to the WHO diagnostic criteria.
  2. Understand and voluntarily sign an informed consent form.
  3. Age >=18 years at the time of signing the informed consent form.
  4. Able to adhere to the study visit schedule and other protocol requirements.
  5. All previous cancer therapy must have been discontinued at least 4 weeks prior to treatment in this study. Patients carrying a somatic mutation involving the platelet derived growth factor receptor beta (PDGFRB) can be included if standard treatment with imatinib failed.
  6. ECOG performance status of <= 2 at study entry.

  7. Laboratory test results within these ranges:

    • Creatinine clearance > 30ml/min
    • AST (SGOT) and ALT (SGPT) <= 2.5 x ULN
  8. Disease free of prior malignancies for >= 5 years with exception of currently treated basal cell, squamous cell carcinoma of the skin, or carcinoma "in situ" of the cervix or breast.

  9. Female subjects of childbearing potential must:

    • Understand the study drug is expected to have a teratogenic risk
    • Agree to use two effective contraception

  10. Male subjects must

    • Agree to use condoms
    • Agree not to donate semen

  11. All subjects must

    • Agree to abstain from donating blood
    • Agree not to share study drug with another person

Exclusion Criteria:

  1. Any serious medical condition, laboratory abnormality, or psychiatric illness that would prevent the subject from signing the informed consent form.
  2. Pregnant or breast feeding females. (Lactating females must agree not to breast feed while taking lenalidomide).
  3. Any condition, including the presence of laboratory abnormalities, which places the subject at unacceptable risk if he/she were to participate in the study or confounds the ability to interpret data from the study.
  4. Use of any other experimental drug or therapy within 28 days of baseline.
  5. Known hypersensitivity to thalidomide.
  6. The development of erythema nodosum if characterized by a desquamating rash while taking thalidomide or similar drugs.
  7. Any prior use of lenalidomide.
  8. Concurrent use of other anti-cancer agents or treatments.
  9. Known positive for HIV or infectious hepatitis, type A, B or C.

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: NA
  • Interventional Model: SINGLE_GROUP
  • Masking: NONE

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Maximum tolerated dose (MTD)
Time Frame: 2 years
This is a phase I/II, open-label, dose-escalation study of lenalidomide in patients with CMML. In phase I of the study the primary purpose is to determine the MTD. The purpose of phase II is to determine the response rate.
2 years

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Number and seriousness of adverse events to evaluate safety and tolerability
Time Frame: 4 years
For both phases (phase I and II), secondary objectives are to evaluate safety, tolerability, efficacy and analysis of molecular markers.
4 years
Number of patients achieving transfusion independence
Time Frame: 4 years
Phase II
4 years
Progression free survival, Overall survival
Time Frame: 4 years
Phase II
4 years
Patients achieving cytogenetic response
Time Frame: 4 years
Phase II; Cytogenetic response assessment requires 20 analyzable metaphases using conventional cytogenetic techniques, FISH may be used an a supplement to follow a specifically defined cytogenetic abnormality
4 years

Collaborators and Investigators

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

Sponsor

Arbeitsgemeinschaft medikamentoese Tumortherapie

Collaborators

Celgene Corporation

Investigators

  • Study Director: Sonja Burgstaller, MD, Klinikum Wels-Grieskirchen GmbH

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

June 1, 2010

Primary Completion (ANTICIPATED)

May 1, 2015

Study Completion (ANTICIPATED)

May 1, 2015

Study Registration Dates

First Submitted

May 9, 2011

First Submitted That Met QC Criteria

June 7, 2011

First Posted (ESTIMATE)

June 8, 2011

Study Record Updates

Last Update Posted (ESTIMATE)

March 9, 2015

Last Update Submitted That Met QC Criteria

March 6, 2015

Last Verified

March 1, 2015

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • AGMT_CMML 1
  • 2009-017147-33 (EUDRACT_NUMBER)

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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