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Lenalidomide in Patients With Chronic Myelomonocytic Leukemia

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01368757
Recruitment Status : Unknown
Verified March 2015 by Arbeitsgemeinschaft medikamentoese Tumortherapie.
Recruitment status was:  Active, not recruiting
First Posted : June 8, 2011
Last Update Posted : March 9, 2015
Celgene Corporation
Information provided by:
Arbeitsgemeinschaft medikamentoese Tumortherapie

Brief Summary:
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 or disease Intervention/treatment Phase
Chronic Myelomonocytic Leukemia Drug: Revlimid Phase 1 Phase 2

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 30 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Phase I/II Study of Lenalidomide in Patients With Chronic Myelomonocytic Leukemia
Study Start Date : June 2010
Estimated Primary Completion Date : May 2015
Estimated Study Completion Date : May 2015

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

Primary Outcome Measures :
  1. 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.

Secondary Outcome Measures :
  1. 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.

  2. Number of patients achieving transfusion independence [ Time Frame: 4 years ]
    Phase II

  3. Progression free survival, Overall survival [ Time Frame: 4 years ]
    Phase II

  4. 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

Information from the National Library of Medicine

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, Learn About Clinical Studies.

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01368757

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Krankenhaus d. Barmherzigen Schwestern Linz, Interne I
Linz, Oberösterreich, Austria, 4010
Krankenhaus der Elisabethinen Linz GmbH, 1. Interne
Linz, Oberösterreich, Austria, 4010
AKH Linz, Innere Medizin 3, Zentrum für Hämatologie und medizinische Onkologie
Linz, Oberösterreich, Austria, 4021
Klinikum Wels-Grieskirchen GmbH, IV. Interne Abteilung
Wels, Oberösterreich, Austria, 4600
Universitätsklinik f. Innere Medizin Graz, Klinische Abteilung f. Hämatologie
Graz, Steiermark, Austria, 8036
Universitätsklinik für Innere Medizin Innsbruck, Klinische Abteilung für Hämatologie und Onkologie
Innsbruck, Tirol, Austria, 6020
LKH Feldkirch, Interne E
Feldkirch, Vorarlberg, Austria, 6807
Universitaetsklinik der PMU Salzburg, UK f. Innere Medizin III
Salzburg, Austria, 5020
MUW/ AKH Wien Univ. Klinik für Innere Medizin I, Abteilung für Hämatologie und Hämostaseologie
Wien, Austria, 1090
Hanusch Krankenhaus, 3. Med. Abtlg. Für Hämatologie und Onkologie
Wien, Austria, 1140
Sponsors and Collaborators
Arbeitsgemeinschaft medikamentoese Tumortherapie
Celgene Corporation
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Study Director: Josef Thaler, MD Klinikum Wels-Grieskirchen GmbH
Study Director: Sonja Burgstaller, MD Klinikum Wels-Grieskirchen GmbH
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Responsible Party: Prof. Dr. Richard Greil, Arbeitsgemeinschaft medikamentoese Tumortherapie Identifier: NCT01368757    
Other Study ID Numbers: AGMT_CMML 1
2009-017147-33 ( EudraCT Number )
First Posted: June 8, 2011    Key Record Dates
Last Update Posted: March 9, 2015
Last Verified: March 2015
Keywords provided by Arbeitsgemeinschaft medikamentoese Tumortherapie:
Chronic myelomonocytic leukemia
Additional relevant MeSH terms:
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Leukemia, Myelomonocytic, Acute
Leukemia, Myelomonocytic, Chronic
Leukemia, Myelomonocytic, Juvenile
Neoplasms by Histologic Type
Leukemia, Myeloid
Myelodysplastic-Myeloproliferative Diseases
Bone Marrow Diseases
Hematologic Diseases
Immunologic Factors
Physiological Effects of Drugs
Angiogenesis Inhibitors
Angiogenesis Modulating Agents
Growth Substances
Growth Inhibitors
Antineoplastic Agents