Study to assess the efficacy and the safetyof front-line therapy (Fludarabine, Cyclophosphamide and Ofatumumab) in young (=65 yrs) patientswith Chronic Lymphocytic Leukemia (CLL)

• Conditions: Chronic Lymphocytic Leukemia; MedDRA version: 14.1Level: LLTClassification code 10008976Term: Chronic lymphocytic leukemiaSystem Organ Class: 100000004864; Therapeutic area: Diseases [C] - Blood and lymphatic diseases [C15]

• Registration Number: EUCTR2011-005329-27-IT
• Lead Sponsor: G.I.M.EM.A.Gruppo Italiano Malattie Ematologiche dell'Adulto

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2013-05-29
• Last Update Posted: 10 February 2014

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: All
• Target Recruitment: Not specified

Inclusion Criteria

-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:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 80
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

-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.
-One or more laboratory abnormalities:
1.Calculated creatinine clearance (Cockroft-Gault)<60mL/min.
2.Absolute granulocyte count <1500/µL not disease related.
3.Platelet count < 75000/µL not disease related.
4.GOT, GPT, ?GT, alkaline phosphatase > 1,5 x upper limit of normal value unless due to disease involvement); serum bilirubin >1.5mg/dL, subjects who have current active hepatic or biliary disease (with exception of patients with Gilbert's syndrome, asymptomatic gallstones)
-Treatment with any known non-marketed drug substance or experimental therapy within 5 terminal half lives or 4 weeks prior to enrolment, whichever is longer, or currently participating in any other interventional clinical study
-Other past or current malignancy. Subjects who have been free of malignancy for at least 5 years, or have a history of completely resected non-melanoma skin cancer, or successfully treated in situ carcinoma are eligible.

Study & Design

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