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 个研究点目标入组 62 人开始时间: 待定最近更新: 2024年4月29日

适应症

试验速览

暂无简介。

•* 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

•* 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;
•* Uncontrolled hyperthyroidism or hypothyroidism;
•* Patients with history of idiopathic deep venous thrombus and/or pulmonary embolism within last three years;
•* Neuropathy * Grade 2;
•* History of active malignancy during the past 5 years with the exception of basal carcinoma of the skin; squamous cell carcinoma of the skin, carcinoma in situ of the cervix, carcinoma in situ of the breast, prostate cancer (TNM stage of T1a or T1b)
•* Current inclusion in other clinical trials.;
•* Any psychological, familial, sociological and geographical condition potentially hampering compliance with the study protocol and follow-up schedule.

发起方

HOVO