Fludarabine/Rituximab combined with escalating doses of Lenalidomide in untreated chronic lymphocytic leukemia (CLL) – a dose-finding study with escalating starting dose of Lenalidomide and concomitant evaluation of safety and efficacy

Overview

No summary available.

Registry

who.int

Start Date

May 22, 2012

End Date

TBD

Last Updated

11 years ago

Study Type

Interventional clinical trial of medicinal product

Sex

All

Sponsor

•Signed written informed consent
•Male or female \= 18 years of age
•CLL (as determined by CD23\+, CD5\+, CD19\+)
•Treatment indication as defined by the NCI Workshop criteria (see appendix 5 and reference 10\)
•No previous treatment of the CLL by chemotherapy, radiotherapy (except localized radiotherapy of 1 lymphatic area) or immunotherapy
•Life expectancy \> 6 months (except prognosis due to high risk CLL)
•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 10

•Active bacterial, viral or fungal infection
•Positivity for HIV, Hepatitis B or C
•Reduced organ functions and bone marrow dysfunction not due to CLL
•Creatinine clearance of below 30 ml/min
•Patients with a history of other malignancies within 2 years prior to study entry (except for adequately treated carcinoma in situ of the cervix; basal or squamous cell skin cancer; low grade, early stage localized prostate cancer treated surgically with curative intent; good prognosis DCIS of the breast treated with lumpectomy alone with curative intent)
•Patients with medical co\-morbid conditions that would require long term use (\> 1 month) of systemic corticosteroids during study treatment
•Patients with a history of severe cardiac disease; e.g. NYHA Functional Class III or IV heart failure, myocardial infarction within 6 months, ventricular tachyarrhythmias requiring ongoing treatment, or unstable angina
•Other known co\-morbidity with the potential to dominate survival
•Transformation to aggressive B\-cell malignancy (e.g., large B\-cell lymphoma, Richter'ssyndrome, or prolymphocytic leukemia (PLL))
•Hypersensitivity with anaphylactic reaction to humanised monoclonal antibodies or any of the applied drugs