Phase 2 multicenter study to assess the efficacy and the safetyof front-line Fludarabine, Cyclophosphamide and Ofatumumab(FCO2) chemoimmunotherapy in young (=65 yrs) patientswith Chronic Lymphocytic Leukemia (CLL)

G.I.M.EM.A.Gruppo Italiano Malattie Ematologiche dell'Adulto0 sitesMay 29, 2013

Overview

No summary available.

Registry

who.int

Start Date

May 29, 2013

End Date

TBD

Last Updated

12 years ago

Study Type

Interventional clinical trial of medicinal product

Sex

All

Sponsor

G.I.M.EM.A.Gruppo Italiano Malattie Ematologiche dell'Adulto

•\-B\-cell CLL diagnosis by 2008 revised IWCLL criteria.
•\-Treatment requirement according to the 2008 revised IWCLL criteria.
•\-No previous treatment.
•\-Age \> 18 year and \= 65 years.
•\-ECOG performance status of 0\-1 at study entry and CIRS score \=6\.
•\-Adequate renal function (creatinine clearance\=60 ml/min estimated using the Cockcroft\-Gault equation) .
•\-For male and female subjects of childbearing potential, agreement to use effective contraception.
•\-Signed written informed consent according to ICH/EU/GCP and national local laws.
•Are the trial subjects under 18? no
•Number of subjects for this age range:

•\-Significant concurrent, uncontrolled medical condition including, but not limited to, renal, hepatic, gastrointestinal, endocrine, pulmonary, neurological, cerebral or psychiatric disease and/or laboratory abnormality which in the opinion of the investigator may represent a risk for the patient and/or that would prevent the subject from signing the informed consent form.
•\-Pregnant or lactating females.
•\-Known positive serology for HIV.
•\-Positive serology for Hepatitis B (HBV) defined as a positive test for HBsAg and HBV\-DNA.
•\-HCV\-RNA positive.
•\-Chronic or current infectious disease requiring systemic antibiotics, antifungal, or antiviral treatment such as, but not limited to, chronic renal infection, chronic chest infection, tuberculosis and active hepatitis.
•\-History of tuberculosis within the last five years or recent exposure to tuberculosis equal to or less than 6 months.
•\-Known presence of alcohol and/or drug abuse.
•\-Clinically significant cardiac disease including unstable angina, acute myocardial infarction within six months prior to the inclusion in the study, congestive heart failure (NYHA III\-IV), arrhythmia unless controlled by therapy.\= grade 2 neuropathy; history of significant cerebrovascular disease in the past 6 months or ongoing event with active symptoms or sequelae.
•\-Uncontrolled autoimmune hemolytic anemia or thrombocytopenia.