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Lenalidomide in Patients With Chronic Myelomonocytic Leukemia

This study is currently recruiting participants.
Verified June 2011 by Arbeitsgemeinschaft medikamentoese Tumortherapie
Sponsor:
Collaborator:
Celgene Corporation
Information provided by:
Arbeitsgemeinschaft medikamentoese Tumortherapie
ClinicalTrials.gov Identifier:
NCT01368757
First received: May 9, 2011
Last updated: June 7, 2011
Last verified: June 2011
History of Changes
  Purpose

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.


Condition Intervention Phase
Chronic Myelomonocytic Leukemia
 Drug: Revlimid
 Phase 1
Phase 2

Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: A Phase I/II Study of Lenalidomide in Patients With Chronic Myelomonocytic Leukemia

Resource links provided by NLM:

MedlinePlus related topics: Leukemia
U.S. FDA Resources

Further study details as provided by Arbeitsgemeinschaft medikamentoese Tumortherapie:

Primary Outcome Measures:
  • Maximum tolerated dose (MTD) [ Time Frame: 2 years ] [ Designated as safety issue: Yes ]
    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.


Secondary Outcome Measures:
  • Number and seriousness of adverse events to evaluate safety and tolerability [ Time Frame: 4 years ] [ Designated as safety issue: Yes ]
    For both phases (phase I and II), secondary objectives are to evaluate safety, tolerability, efficacy and analysis of molecular markers.

  • Number of patients achieving transfusion independence [ Time Frame: 4 years ] [ Designated as safety issue: No ]
    Phase II

  • Progression free survival, Overall survival [ Time Frame: 4 years ] [ Designated as safety issue: No ]
    Phase II

  • Patients achieving cytogenetic response [ Time Frame: 4 years ] [ Designated as safety issue: No ]
    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


Estimated Enrollment: 30
Study Start Date: June 2010
Estimated Primary Completion Date: December 2011 (Final data collection date for primary outcome measure)
Intervention Details:
    Drug: Revlimid

    Dose escalation 5mg - 10mg - 15mg - 20mg in cohorts of three patients

    The first step of phase I will be 5 mg lenalidomide in a daily regimen, the next step will be 10 mg in a daily regimen, the dosis of the following steps will be increased by 5 mg each until dose limiting toxicity (DLT) is reached.

    Phase II will be started at the MTD (1 dose step below DLT) and will be administered in a daily regimen.

    Other Names:
    • lenalidomide
    • lenalidomid
  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01368757

Contacts
Contact: Daniela Wolkersdorfer, PhD +43 662 8842 ext 4109 d.wolkersdorfer@agmt.at

Locations
Austria
Krankenhaus d. Barmherzigen Schwestern Linz, Interne I Recruiting
Linz, Oberösterreich, Austria, 4010
Principal Investigator: Andreas Petzer, MD            
Krankenhaus der Elisabethinen Linz GmbH, 1. Interne Recruiting
Linz, Oberösterreich, Austria, 4010
Principal Investigator: Otto Krieger, MD            
AKH Linz, Innere Medizin 3, Zentrum für Hämatologie und medizinische Onkologie Recruiting
Linz, Oberösterreich, Austria, 4021
Principal Investigator: Michael Fridrik, MD            
Klinikum Wels-Grieskirchen GmbH, IV. Interne Abteilung Recruiting
Wels, Oberösterreich, Austria, 4600
Principal Investigator: Josef Thaler, MD            
Principal Investigator: Sonja Burgstaller, MD            
Universitätsklinik f. Innere Medizin Graz, Klinische Abteilung f. Hämatologie Not yet recruiting
Graz, Steiermark, Austria, 8036
Principal Investigator: Werner Linkesch, MD            
Universitätsklinik für Innere Medizin Innsbruck, Klinische Abteilung für Hämatologie und Onkologie Recruiting
Innsbruck, Tirol, Austria, 6020
Principal Investigator: Dominik Wolf, MD            
LKH Feldkirch, Interne E Recruiting
Feldkirch, Vorarlberg, Austria, 6807
Principal Investigator: Alois Lang, OA Dr.            
Universitaetsklinik der PMU Salzburg, UK f. Innere Medizin III Recruiting
Salzburg, Austria, 5020
Principal Investigator: Richard Greil, MD            
MUW/ AKH Wien Univ. Klinik für Innere Medizin I, Abteilung für Hämatologie und Hämostaseologie Not yet recruiting
Wien, Austria, 1090
Principal Investigator: Peter Valent, MD            
Hanusch Krankenhaus, 3. Med. Abtlg. Für Hämatologie und Onkologie Recruiting
Wien, Austria, 1140
Principal Investigator: Thomas Nösslinger, MD            
Sponsors and Collaborators
Arbeitsgemeinschaft medikamentoese Tumortherapie
Celgene Corporation
Investigators
Study Director: Josef Thaler, MD Klinikum Wels-Grieskirchen GmbH
Study Director: Sonja Burgstaller, MD Klinikum Wels-Grieskirchen GmbH
  More Information

No publications provided

Responsible Party: Prof. Dr. Richard Greil, Arbeitsgemeinschaft medikamentoese Tumortherapie
ClinicalTrials.gov Identifier: NCT01368757     History of Changes
Other Study ID Numbers: AGMT_CMML 1, 2009-017147-33
Study First Received: May 9, 2011
Last Updated: June 7, 2011
Health Authority: Austria: Agency for Health and Food Safety

Keywords provided by Arbeitsgemeinschaft medikamentoese Tumortherapie:
Chronic myelomonocytic leukemia
CMML
Lenalidomide
Revlimid

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

ClinicalTrials.gov processed this record on May 22, 2013