Chronic Lymphocytic Leukemia patients relapsed or refractory after fludarabine containing regimens MedDRA version: 14.1 Level: LLT Classification code 10008956 Term: Chronic lymphatic leukaemia System Organ Class: 100000004864
Conditions
Interventions
Trade Name: REVLIMID*21CPS 5MG
Pharmaceutical Form: Capsule, hard
INN or Proposed INN: LENALIDOMIDE
CAS Number: 191732-72-6
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration
Sponsors
A.O. UNIVERSITARIA INTEGRATA DI VERONA
Eligibility
Sex/Gender
All
Inclusion criteria
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 2 mg/dl if Gilbert’s Sindrome). · ALT and AST =65 years) yes F.1.3.1 Number of subjects for this age range 9
Exclusion criteria
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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To evaluate the safety and the efficacy of Ofatumumab and Lenalidomide combination in patients with relapsed/refractory CLL;Secondary Objective: To evaluate quality of responses and biological assessments, Adverse Events;Primary end point(s): ORR, AE and SAE in terms of frequency and severity;Timepoint(s) of evaluation of this end point: at six months | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): · CRR according to NCI guidelines · PFS ·Time to a next CLL treatment (TTNT) ·Effect of LENOFA on biological features of CLL-cells from treated patients;Timepoint(s) of evaluation of this end point: · CRR according at six months · PFS max at 24 months ·Time to a next CLL treatment (TTNT) ·Effect of LENOFA on biological features of CLL-cells from treated patients, max at six months | — |
Countries
Italy
Contacts
Public ContactContact point
Centro Ricerche Cliniche di Verona
Outcome results
None listed