Phase 2 Multicenter, Study to Assess the Efficacy and the Safety of Front-line Fludarabine, Cyclophoshamide and Ofatumumab (FCO2) Chemoimmunotherapy in Young (≤65 Yrs) Patients With Chronic Lymphocytic Leukemia (CLL).
- rituximab, fludarabine and cyclophosphamide (FCR) front-line treatment was associated
with a high OR rate, superior PFS and OS as compared to fludarabine and
- a direct relationship between the dose of rituximab and the response rate has been
- ofatumumab, as single agent, proved activity in CLL patients with refractory disease;
- ofatumumab, fludarabine and cylophosphamide (O-FC) front-line treatment has been
associated with a high complete response (CR) rate;
- the expected grade 3-4 granulocytopenia could led to reduce the dose intensity of study
drugs (FC) and increase the infection rate; a schedule combining FC with an increased
dose of ofatumumab associated to primary phrophylaxis of granulocytopenia could be
associated with an improvement in the CR rate. The purpose of this study is to
determine whether we could improve the CR rate of the golden standard treatment for fit
patients with CLL , the FCR regimen, with a chemoimmunotherapy including FC combined
with an increased dose of the monoclonal antibody ofatumumab, given every other week
(FCO2) associated with a primary prophylaxis of granulocytopenia.
Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Number of complete responses.
The complete response (CR) rate after FCO2 front-line treatment.
After 8 months from study entry.
Roberto Foà, Pr.
Policlinico Umberto I, Hematology Department.
Italy: Ethics Committee