Clinical trial NCT01368757: 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
Overall status: UNKNOWN
Phase: PHASE1
PHASE2
Conditions: Chronic Myelomonocytic Leukemia
Keywords: Chronic myelomonocytic leukemia
CMML
Lenalidomide
Revlimid
Lead sponsor: Arbeitsgemeinschaft medikamentoese Tumortherapie
Sponsor class: OTHER
Collaborators: name: Celgene Corporation
First posted: 2011-06-08
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.


Eligibility 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.

Primary outcomes:
measure: Maximum tolerated dose (MTD)
timeFrame: 2 years
Secondary outcomes:
measure: Number and seriousness of adverse events to evaluate safety and tolerability
timeFrame: 4 years
measure: Number of patients achieving transfusion independence
timeFrame: 4 years
measure: Progression free survival, Overall survival
timeFrame: 4 years
measure: Patients achieving cytogenetic response
timeFrame: 4 years
Other outcomes:
Locations:
city: Linz
country: Austria
facility: Krankenhaus d. Barmherzigen Schwestern Linz, Interne I
state: Oberösterreich
city: Linz
country: Austria
facility: Krankenhaus der Elisabethinen Linz GmbH, 1. Interne
state: Oberösterreich
city: Linz
country: Austria
facility: AKH Linz, Innere Medizin 3, Zentrum für Hämatologie und medizinische Onkologie
state: Oberösterreich
city: Wels
country: Austria
facility: Klinikum Wels-Grieskirchen GmbH, IV. Interne Abteilung
state: Oberösterreich
city: Graz
country: Austria
facility: Universitätsklinik f. Innere Medizin Graz, Klinische Abteilung f. Hämatologie
state: Steiermark
city: Innsbruck
country: Austria
facility: Universitätsklinik für Innere Medizin Innsbruck, Klinische Abteilung für Hämatologie und Onkologie
state: Tirol
city: Feldkirch
country: Austria
facility: LKH Feldkirch, Interne E
state: Vorarlberg
city: Salzburg
country: Austria
facility: Universitaetsklinik der PMU Salzburg, UK f. Innere Medizin III
city: Wien
country: Austria
facility: MUW/ AKH Wien Univ. Klinik für Innere Medizin I, Abteilung für Hämatologie und Hämostaseologie
city: Wien
country: Austria
facility: Hanusch Krankenhaus, 3. Med. Abtlg. Für Hämatologie und Onkologie
Study officials:
affiliation: Klinikum Wels-Grieskirchen GmbH
name: Josef Thaler, MD
role: STUDY_DIRECTOR
affiliation: Klinikum Wels-Grieskirchen GmbH
name: Sonja Burgstaller, MD
role: STUDY_DIRECTOR
References: