Clinical Trial: Rituximab in Children and Adolescents With Relapsed and Refractory B-Cell NHL/L3ALL

Study Status: Terminated
Recruit Status: Terminated
Study Type: Interventional

Official Title: A Phase II Study of Mabthera (Rituximab) in Children and Adolescents With Relapsed and Refractory B-Cell NHL/L3ALL

Brief Summary: 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, large B-cell lymphoma and non subclassified aggressive B-cell NHL

Detailed Summary:

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.


Sponsor: Gustave Roussy, Cancer Campus, Grand Paris

Current Primary Outcome: Rate of patients achieving at least objective response after 2 courses of rituximab

Original Primary Outcome: Same as current

Current Secondary Outcome:

  • Rate of objective response after 4 courses of rituximab
  • Rate of initially responding patients who progressed during the second phase of treatment
  • Toxicity
  • Pharmacokinetic evaluation in serum and CSF


Original Secondary Outcome: Same as current

Information By: Gustave Roussy, Cancer Campus, Grand Paris

Dates:
Date Received: September 12, 2005
Date Started: June 2004
Date Completion:
Last Updated: September 7, 2006
Last Verified: September 2006