Lenalidomide in Patients With Chronic Myelomonocytic Leukemia

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborator:
Celgene Corporation
Information provided by:
Arbeitsgemeinschaft medikamentoese Tumortherapie
ClinicalTrials.gov Identifier:
NCT01368757
First received: May 9, 2011
Last updated: September 9, 2014
Last verified: September 2014
  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:


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 Study Completion Date: December 2014
Estimated Primary Completion Date: December 2014 (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
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, see Learn About Clinical Studies.

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

Locations
Austria
Krankenhaus d. Barmherzigen Schwestern Linz, Interne I
Linz, Oberösterreich, Austria, 4010
AKH Linz, Innere Medizin 3, Zentrum für Hämatologie und medizinische Onkologie
Linz, Oberösterreich, Austria, 4021
Krankenhaus der Elisabethinen Linz GmbH, 1. Interne
Linz, Oberösterreich, Austria, 4010
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
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: September 9, 2014
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, Acute
Leukemia, Myelomonocytic, Chronic
Bone Marrow Diseases
Hematologic Diseases
Leukemia, Myeloid
Myelodysplastic-Myeloproliferative Diseases
Neoplasms
Neoplasms by Histologic Type
Lenalidomide
Thalidomide
Angiogenesis Inhibitors
Angiogenesis Modulating Agents
Anti-Bacterial Agents
Anti-Infective Agents
Antineoplastic Agents
Growth Inhibitors
Growth Substances
Immunologic Factors
Immunosuppressive Agents
Leprostatic Agents
Pharmacologic Actions
Physiological Effects of Drugs
Therapeutic Uses

ClinicalTrials.gov processed this record on October 21, 2014