A Phase I/II Study of Lenalidomide in Patients with Chronic Myelomonocytic Leukemia

Conditions: Chronic Myelomonocytic Leukemia (CMML)
MedDRA version: 17.1Level: LLTClassification code 10054350Term: Chronic myelomonocytic leukemiaSystem Organ Class: 100000004864
Therapeutic area: Diseases [C] - Cancer [C04]

Registration Number: EUCTR2009-017147-33-AT

Lead Sponsor: AGMT gemeinnützige GmbH

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: ot Recruiting

Sex: All

Target Recruitment: Not specified

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

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.