Chronic Myelomonocytic Leukemia (CMML) MedDRA version: 17.1 Level: LLT Classification code 10054350 Term: Chronic myelomonocytic leukemia System Organ Class: 100000004864
Conditions
Sponsors
AGMT gemeinnützige GmbH
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: selected 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. Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 20 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 20
Exclusion criteria
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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Secondary Objective: Phase I: Secondary objectives include the evaluation of safety and tolerability. Phase II: The secondary objectives focus on achieving transfusion independence and cytogenetic response. In addition, progression free survival and overall survival will be determined.;Primary end point(s): Phase I: The primary objective of the phase I trial is to determine the MTD (maximum tolerated dose) of lenalidomide. Phase II: The primary objective of the phase II trial is to determine the hematologic response achieved with lenalidomide administered in subjects at the MTD determined in phase I. ;Main Objective: Phase I: The primary objective of the phase I trial is to determine the MTD (maximum tolerated dose) of lenalidomide. Phase II: The primary objective of the phase II trial is to determine the hematologic response achieved with lenalidomide administered in subjects at the MTD determined in phase I. ;Timepoint(s) of evaluation of this end point: Enrollment: 36 months Active treatment: until progression Follow up: 12 months | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): Phase I: Secondary objectives include the evaluation of safety and tolerability. Phase II: The secondary objectives focus on achieving transfusion independence and cytogenetic response. In addition, progression free survival and overall survival will be determined.;Timepoint(s) of evaluation of this end point: Enrollment: 36 months Active treatment: until progression Follow up: 12 months | — |
Countries
Austria
Contacts
Public ContactDr. Daniela Wolkersdorfer
AGMT gemeinnützige GmbH
Outcome results
None listed