A Phase II Study of Mabthera (Rituximab) in Children and Adolescents With Relapsed and Refractory B-Cell NHL/L3ALL
This is a multicentric phase II study of Mabthera (rituximab) in children and adolescents
with relapsed and refractory B-cell NHL/L3ALL. The primary objective is to determine the
response rate of Rituximab as single agent in relapsed or refractory Burkitt lymphoma, L3
acute leukemia, diffuse large B-cell lymphoma and non subclassified aggressive B-cell NHL.
The secondary objectives are to assess the toxicity profile of Rituximab in children and
adolescents as single agent, and when followed by chemotherapy, to study pharmacokinetics of
Rituximab in serum and in CSF and to determine the overall duration of response, time to
progression and survival in patients responders to antiCD20 initially alone and followed by
chemotherapy.
Patients will receive Rituximab (Mabthera) at 375 mg/m2, once a week during 4 weeks,
administered in IV infusion starting at 50mg/h and increasing by steps of 50 mg/h every 30mn
until the speed of 400 mg/h. Patients with combined CNS relapse will receive an intrathecal
injection of MTX+HC+Ara-C 48 h after each injection of rituximab First assessment will be
done prior to receiving the 3rd course of rituximab. Responding patients (CR, PR) and
patients with objective effect (OE) will receive the 3rd and 4th injections of rituximab
before starting the salvage chemotherapy (COPADM, CYVE/CC course or ICE, depending on
previous chemotherapy regimen received by the patient, followed by HDCT+ hematopoietic stem
cell rescue). A second evaluation will be done after the 4th course if performed.
Interventional
Allocation: Non-Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Rate of patients achieving at least objective response after 2 courses of rituximab
Catherine Patte, MD
Principal Investigator
Gustave Roussy, Cancer Campus, Grand Paris
France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)
Rituximab childhood
NCT00180895
June 2004
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