Lenalidomide in Patients With Chronic Myelomonocytic Leukemia

The recruitment status of this study is unknown because the information has not been verified recently.
Verified June 2011 by Arbeitsgemeinschaft medikamentoese Tumortherapie.
Recruitment status was  Recruiting
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

May 9, 2011
June 7, 2011
June 2010
December 2011   (final data collection date for primary outcome measure)
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.
Same as current
Complete list of historical versions of study NCT01368757 on ClinicalTrials.gov Archive Site
  • 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
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
Interventional
Phase 1
Phase 2
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: 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 ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
30
Not Provided
December 2011   (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.
Both
18 Years and older
No
Contact: Daniela Wolkersdorfer, PhD +43 662 8842 ext 4109 d.wolkersdorfer@agmt.at
Austria
 
NCT01368757
AGMT_CMML 1, 2009-017147-33
No
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
June 2011

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