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Lenalidomide in Patients With Chronic Myelomonocytic Leukemia

Primary Purpose

Chronic Myelomonocytic Leukemia

Status
Unknown status
Phase
Phase 1
Locations
Austria
Study Type
Interventional
Intervention
Revlimid
Sponsored by
Arbeitsgemeinschaft medikamentoese Tumortherapie
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Chronic Myelomonocytic Leukemia focused on measuring Chronic myelomonocytic leukemia, CMML, Lenalidomide, Revlimid

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Krankenhaus d. Barmherzigen Schwestern Linz, Interne I
  • Krankenhaus der Elisabethinen Linz GmbH, 1. Interne
  • AKH Linz, Innere Medizin 3, Zentrum für Hämatologie und medizinische Onkologie
  • Klinikum Wels-Grieskirchen GmbH, IV. Interne Abteilung
  • Universitätsklinik f. Innere Medizin Graz, Klinische Abteilung f. Hämatologie
  • Universitätsklinik für Innere Medizin Innsbruck, Klinische Abteilung für Hämatologie und Onkologie
  • LKH Feldkirch, Interne E
  • Universitaetsklinik der PMU Salzburg, UK f. Innere Medizin III
  • MUW/ AKH Wien Univ. Klinik für Innere Medizin I, Abteilung für Hämatologie und Hämostaseologie
  • Hanusch Krankenhaus, 3. Med. Abtlg. Für Hämatologie und Onkologie

Outcomes

Primary Outcome Measures

Maximum tolerated dose (MTD)
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
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
Phase II
Progression free survival, Overall survival
Phase II
Patients achieving cytogenetic response
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

Full Information

First Posted
May 9, 2011
Last Updated
March 6, 2015
Sponsor
Arbeitsgemeinschaft medikamentoese Tumortherapie
Collaborators
Celgene Corporation
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1. Study Identification

Unique Protocol Identification Number
NCT01368757
Brief Title
Lenalidomide in Patients With Chronic Myelomonocytic Leukemia
Official Title
A Phase I/II Study of Lenalidomide in Patients With Chronic Myelomonocytic Leukemia
Study Type
Interventional

2. Study Status

Record Verification Date
March 2015
Overall Recruitment Status
Unknown status
Study Start Date
June 2010 (undefined)
Primary Completion Date
May 2015 (Anticipated)
Study Completion Date
May 2015 (Anticipated)

3. Sponsor/Collaborators

Name of the Sponsor
Arbeitsgemeinschaft medikamentoese Tumortherapie
Collaborators
Celgene Corporation

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Chronic Myelomonocytic Leukemia
Keywords
Chronic myelomonocytic leukemia, CMML, Lenalidomide, Revlimid

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1, Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
30 (Anticipated)

8. Arms, Groups, and Interventions

Intervention Type
Drug
Intervention Name(s)
Revlimid
Other Intervention Name(s)
lenalidomide, lenalidomid
Intervention Description
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.
Primary Outcome Measure Information:
Title
Maximum tolerated dose (MTD)
Description
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.
Time Frame
2 years
Secondary Outcome Measure Information:
Title
Number and seriousness of adverse events to evaluate safety and tolerability
Description
For both phases (phase I and II), secondary objectives are to evaluate safety, tolerability, efficacy and analysis of molecular markers.
Time Frame
4 years
Title
Number of patients achieving transfusion independence
Description
Phase II
Time Frame
4 years
Title
Progression free survival, Overall survival
Description
Phase II
Time Frame
4 years
Title
Patients achieving cytogenetic response
Description
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
Time Frame
4 years

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: CMML according to the WHO diagnostic criteria. Understand and voluntarily sign an informed consent form. Age >=18 years at the time of signing the informed consent form. Able to adhere to the study visit schedule and other protocol requirements. 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. ECOG performance status of <= 2 at study entry. Laboratory test results within these ranges: Creatinine clearance > 30ml/min AST (SGOT) and ALT (SGPT) <= 2.5 x ULN 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. Female subjects of childbearing potential must: Understand the study drug is expected to have a teratogenic risk Agree to use two effective contraception Male subjects must Agree to use condoms Agree not to donate semen All subjects must Agree to abstain from donating blood Agree not to share study drug with another person Exclusion Criteria: Any serious medical condition, laboratory abnormality, or psychiatric illness that would prevent the subject from signing the informed consent form. Pregnant or breast feeding females. (Lactating females must agree not to breast feed while taking lenalidomide). 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. Use of any other experimental drug or therapy within 28 days of baseline. Known hypersensitivity to thalidomide. The development of erythema nodosum if characterized by a desquamating rash while taking thalidomide or similar drugs. Any prior use of lenalidomide. Concurrent use of other anti-cancer agents or treatments. Known positive for HIV or infectious hepatitis, type A, B or C.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Josef Thaler, MD
Organizational Affiliation
Klinikum Wels-Grieskirchen GmbH
Official's Role
Study Director
First Name & Middle Initial & Last Name & Degree
Sonja Burgstaller, MD
Organizational Affiliation
Klinikum Wels-Grieskirchen GmbH
Official's Role
Study Director
Facility Information:
Facility Name
Krankenhaus d. Barmherzigen Schwestern Linz, Interne I
City
Linz
State/Province
Oberösterreich
ZIP/Postal Code
4010
Country
Austria
Facility Name
Krankenhaus der Elisabethinen Linz GmbH, 1. Interne
City
Linz
State/Province
Oberösterreich
ZIP/Postal Code
4010
Country
Austria
Facility Name
AKH Linz, Innere Medizin 3, Zentrum für Hämatologie und medizinische Onkologie
City
Linz
State/Province
Oberösterreich
ZIP/Postal Code
4021
Country
Austria
Facility Name
Klinikum Wels-Grieskirchen GmbH, IV. Interne Abteilung
City
Wels
State/Province
Oberösterreich
ZIP/Postal Code
4600
Country
Austria
Facility Name
Universitätsklinik f. Innere Medizin Graz, Klinische Abteilung f. Hämatologie
City
Graz
State/Province
Steiermark
ZIP/Postal Code
8036
Country
Austria
Facility Name
Universitätsklinik für Innere Medizin Innsbruck, Klinische Abteilung für Hämatologie und Onkologie
City
Innsbruck
State/Province
Tirol
ZIP/Postal Code
6020
Country
Austria
Facility Name
LKH Feldkirch, Interne E
City
Feldkirch
State/Province
Vorarlberg
ZIP/Postal Code
6807
Country
Austria
Facility Name
Universitaetsklinik der PMU Salzburg, UK f. Innere Medizin III
City
Salzburg
ZIP/Postal Code
5020
Country
Austria
Facility Name
MUW/ AKH Wien Univ. Klinik für Innere Medizin I, Abteilung für Hämatologie und Hämostaseologie
City
Wien
ZIP/Postal Code
1090
Country
Austria
Facility Name
Hanusch Krankenhaus, 3. Med. Abtlg. Für Hämatologie und Onkologie
City
Wien
ZIP/Postal Code
1140
Country
Austria

12. IPD Sharing Statement

Learn more about this trial

Lenalidomide in Patients With Chronic Myelomonocytic Leukemia

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