Overview
Assessment of Efficacy and Safety of Front-line Fludarabine, Cyclophoshamide and Ofatumumab Chemoimmunotherapy in Young Patients With Chronic Lymphocytic Leukemia.
Status:
Completed
Completed
Trial end date:
2018-10-01
2018-10-01
Target enrollment:
0
0
Participant gender:
All
All
Summary
Assessment of safety and efficacy of with fludarabine and cyclophosphamide (FC) combined with ofatumumab (FCO2) in previously untreated "young" patients with Chronic Lymphocytic Leukemia (CLL).Phase:
Phase 2Accepts Healthy Volunteers?
NoDetails
Lead Sponsor:
Gruppo Italiano Malattie EMatologiche dell'AdultoTreatments:
Antibodies, Monoclonal
Cyclophosphamide
Fludarabine
Fludarabine phosphate
Ofatumumab
Vidarabine
Criteria
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-Gaultequation) .
- For male and female subjects of childbearing potential, agreement to use effective
contraception.
- Signed written informed const according to ICH/EU/GCP and national local laws.
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/ƒÊL not disease related.
3. Platelet count < 75000/ƒÊL 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 enrollment, 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.