Study to assess the safety and efficacy of Lenalidomide and Ofatumumab combination (Lenofa) in chronic lymphocytic leukenia (CLL) patients relapsed or refractory after fludarabine containing regimens

• Conditions: Chronic Lymphocytic Leukemia patients relapsed or refractory after fludarabine containing regimens; MedDRA version: 14.1Level: LLTClassification code 10008956Term: Chronic lymphatic leukaemiaSystem Organ Class: 100000004864; Therapeutic area: Diseases [C] - Cancer [C04]

• Registration Number: EUCTR2012-000634-20-IT
• Lead Sponsor: A.O. UNIVERSITARIA INTEGRATA DI VERONA

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2012-10-31
• Last Update Posted: 11 April 2016

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: Not specified

Inclusion Criteria

· B-cell CLL diagnosis by 2008 revised NCI criteria · Advanced stage or progressive CLL according to the 2008 revised NCI. criteria · Age > or = 18 years or 75 years · Patients relapsed or refractory after at least one Fludarabine containing regimen. · ECOG performance status of o = 1.000/µL, not disease related · Platelet count > 50000/µL, not disease related · Calculated creatinine clearance > 60 mL/min and creatinine < 1.5 mg/dL · Total bilirubin 2 mg/dl if Gilbert’s Sindrome). · ALT and AST < 3x upper normal limit. · Female patients of Child-Bearing Potential (FCBP) must have 2 negative medically supervised pregnancy tests prior to starting the drug. They must agree to ongoing pregnancy testing during the course of the study (see appendix I), and after the end of the study therapy. They must adopt two reliable methods of contraception and avoid becoming pregnant for at least 28 days after the discontinuation of the study drug. · Male patients must agree to use latex condoms during sexual contacts with female of child-bearing potential even if they have had a vasectomy, throughout study drug therapy, during any drug interruption and after cessation of study therapy. They must agree not to donate blood or semen for up to 28 days after study drug discontinuation.
Are the trial subjects under 18? no
Number of subjects for this age range: 0
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 13
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 9

Exclusion Criteria

· Any serious medical condition, laboratory abnormality, or psychiatric illness that would prevent the subject from signing the informed consent form · History of tuberculosis within the last five years or recent exposure to tuberculosis equal to or less than 6 months · History of renal failure requiring dialysis · Bulky CLL · Known presence of alcohol and/or drug abuse · History of thrombosis, thromboembolism within one year · Heart failure, arrhythmia · grade 2 neuropathy · Uncontrolled hyperthyroidism or hypothyroidism · Uncontrolled autoimmune hemolytic anemia or thrombocytemia · Calculated creatinine clearance (Cockroft-Gault) <60mL/min · Electrolyte abnormalities according to the Cairo Bishop definition of laboratory TLS. Subjects meeting any of the following criteria must not be enrolled in an Ofatumumab study: · Subjects who have current active hepatic or biliary disease (with exception of patients with Gilbert's syndrome, asymptomatic gallstones, liver metastases or stable chronic liver disease per investigator assessment) · Treatment with any known non-marketed drug substance or experimental therapy within 5 terminal half lives or 4 weeks prior to enrollment, whichever is longer, or currently participating in any other interventional clinical study · Prior treatment with anti-CD20 monoclonal antibody or alemtuzumab within 3 months prior to start of therapy. · Chronic or current infectious disease requiring systemic antibiotics, antifungal, or antiviral treatment such as, but not limited to, chronic renal infection, chronic chest infection with bronchiectasis, tuberculosis and active Hepatitis C. · History of significant cerebrovascular disease in the past 6 months or ongoing event with active symptoms or sequelae · Known HIV positive · Clinically significant cardiac disease including unstable angina, acute myocardial infarction within six months prior to start of treatment, congestive heart failure (NYHA III-IV), and arrhythmia unless controlled by therapy, with the exception of extra systoles or minor conduction abnormalities. · Significant concurrent, uncontrolled medical condition including, but not limited to, renal, hepatic, gastrointestinal, endocrine, pulmonary, neurological, cerebral or psychiatric disease which in the opinion of the investigator may represent a risk for the patient. · Positive serology for Hepatitis B (HB) defined as a positive test for HBsAg. In addition, if negative for HBsAg but HBcAb positive (regardless of HBsAb status), a HBV DNA test will be performed and if positive the subject will be excluded. · Positive serology for hepatitis C (HCV) defined as a positive test for HCAb, in which case reflexively perform a HC RIBA immunoblot assay on the same sample to confirm the result · CLL patients affected by Richter’s Syndrome.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified