Trial Information

Phase II Study of Tolerance and Efficacy of Subcutanous Low Doses Rituximab Given as Consolidation Treatment to Chronic Lymphocytic Leukaemia (CLL) Patients Responding to Induction Therapy

Objective(s) of the clinical study

Main objective:

- To improve the minimal residual disease (MRD) negative complete response (CR) rate after
consolidation using subcutaneous low dose of rituximab

Secondary objectives:

- Progression free survival, treatment free survival, overall survival,

- MRD follow-up,

- Safety

- Medico-economic study

- Quality of life study

- Immune functions study (ancillary study)

Main assessment criteria:

MRD negative CR rate, established by peripheral blood 4colour flow cytometry according to
international consensus on CLL MRD study, at the end of the consolidation treatment.

Experimental plan:

Inclusion of patients after the evaluation of response to induction treatment according to
NCI-ICLLWG criteria and MRD analysis (2 to 3 months after induction completion): patients
having not achieved MRD negative CR.

Consolidation treatment by subcutaneous rituximab given at 20 mg/m²/d thrice weekly during
12 weeks.

Evaluation of the response 3 months after completion of the consolidation treatment.

Subjects number: 35 patients will be needed to accept the hypothesis of an augmentation of
CR with negative MRD >=40%, excluding the hypothesis that this rate is < 20%. This ensure us
an alpha risk at 5% with a 80% power, taking into account that non evaluable patients will
be < 5%.

Brief description of the ancillary study:

Immune functions study before and after consolidation treatment by rituximab