NL-OMON36713
Completed
Phase 2
Efficacy and safety of first-line therapy with chlorambucil, rituximab and lenalidomide (Revlimid®) (CR2) in elderly patients and young frail patients with advanced Chronic Lymphocytic Leukemia (CLL): a phase II trial - HOVON 109 C
HOVO0 sites62 target enrollmentTBD
Overview
- Phase
- Phase 2
- Intervention
- Not specified
- Conditions
- Chronic Lymphatic Leukemia
- Sponsor
- HOVO
- Enrollment
- 62
- Status
- Completed
- Last Updated
- 2 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
Inclusion Criteria
- •\* Diagnosis of CLL without prior treatment;
- •\* Patients with symptomatic stage A , according to IWCLL guidelines or stage B or stage C
- •\* Age \* 65 years at the time of signing the informed consent form, or age \<65 years and CIRS \* 7
- •\* Able to adhere to the study visit schedule and other protocol requirements.
- •\* WHO performance status of \* 2;
- •\* Laboratory test results within these ranges: ANC \* 1\.0 x 10^9/l, Platelet count \* 30 x 10^9/l, creatinine clearance \* 60 ml/min, total bilirubin \* 25 µmol/L, AST \& ALT \* 2 x ULN;
- •\* Females of childbearing potential must have a negative serum or urine pregnancy test within 10 \- 14 days prior to and again within 24 hours of starting lenalidomide
- •\* Patients who are willing and capable to use adequate contraception during the therapy (all men, all pre\-menopausal women). Patients must be able to adhere to the requirements of the Lenalidomide Pregnancy Prevention Risk Management Plan;
- •\* Written informed consent
Exclusion Criteria
- •\* Patients that are unable or unwilling to adhere to the requirements of the Lenalidomide Pregnancy Prevention Risk Management Plan;
- •\* Intolerance of exogenous protein administration;
- •\* Hepatitis B Ag positive, Hepatitis C positive and/or HIV positive patients;
- •\* Patients with uncontrolled Autoimmune Hemolytic Anemia (AIHA) or autoimmune thrombocytopenia (ITP);
- •\* Active fungal, bacterial, and/or viral infection;
- •\* Pregnant or breast\-feeding females (lactating females must agree not to breast feed while taking lenalidomide);
- •\* Use of any other experimental drug or therapy within 28 days of baseline;
- •\* Known hypersensitivity and/or serious adverse reactions to lenalidomide or similar drugs;
- •\* Any prior use of lenalidomide;
- •\* Concurrent use of other anti\-cancer agents or treatments;
Outcomes
Primary Outcomes
Not specified
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