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

May 9, 2011
June 8, 2011
March 9, 2015
June 2010
May 2015   (Final data collection date for primary outcome measure)
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.
Same as current
Complete list of historical versions of study NCT01368757 on Archive Site
  • 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.
  • Number of patients achieving transfusion independence [ Time Frame: 4 years ]
    Phase II
  • Progression free survival, Overall survival [ Time Frame: 4 years ]
    Phase II
  • 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
Same as current
Not Provided
Not Provided
Lenalidomide in Patients With Chronic Myelomonocytic Leukemia
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.
Not Provided
Phase 1
Phase 2
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Chronic Myelomonocytic Leukemia
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
Not Provided
Not Provided

*   Includes publications given by the data provider as well as publications identified by Identifier (NCT Number) in Medline.
Unknown status
Same as current
May 2015
May 2015   (Final data collection date for primary outcome measure)

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.
Sexes Eligible for Study: All
18 Years and older   (Adult, Senior)
Contact information is only displayed when the study is recruiting subjects
2009-017147-33 ( EudraCT Number )
Not Provided
Not Provided
Prof. Dr. Richard Greil, Arbeitsgemeinschaft medikamentoese Tumortherapie
Arbeitsgemeinschaft medikamentoese Tumortherapie
Celgene Corporation
Study Director: Josef Thaler, MD Klinikum Wels-Grieskirchen GmbH
Study Director: Sonja Burgstaller, MD Klinikum Wels-Grieskirchen GmbH
Arbeitsgemeinschaft medikamentoese Tumortherapie
March 2015

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP