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

This study has been terminated.
Sponsor:
Collaborator:
Hoffmann-La Roche
Information provided by:
Gustave Roussy, Cancer Campus, Grand Paris
ClinicalTrials.gov Identifier:
NCT00180895
First received: September 12, 2005
Last updated: September 7, 2006
Last verified: September 2006
  Purpose

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


Condition Intervention Phase
Burkitt Lymphoma
Drug: Rituximab
Phase 2

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: A Phase II Study of Mabthera (Rituximab) in Children and Adolescents With Relapsed and Refractory B-Cell NHL/L3ALL

Resource links provided by NLM:


Further study details as provided by Gustave Roussy, Cancer Campus, Grand Paris:

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

Secondary Outcome Measures:
  • 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

Estimated Enrollment: 40
Study Start Date: June 2004
Detailed Description:

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.

  Eligibility

Ages Eligible for Study:   6 Months to 20 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Histologically or cytologically proven B-cell malignancies, either Burkitt NHL or L3 ALL or large B-cell lymphoma or aggressive B-cell NHL, with the exception of diffuse large B-cell lymphoma arising in the mediastinum.
  • Immunohistochemistry showing CD20 positivity
  • Measurable (at least one bi-dimensionally measurable lesion) or evaluable (bone marrow, bone involvement) disease in progression since the last evaluation
  • First relapsed or refractory disease after LMB or BFM protocol, except the isolated CNS relapses
  • Life expectancy > 4 weeks
  • Performance status (Karnofsky) > 30
  • Adequate hepatic, renal and cardiac functions
  • Wash out of 3 weeks in case of recent chemotherapy
  • Complete initial work-up within 8 days prior to treatment
  • Able to comply with scheduled follow-up and with management of toxicity
  • Written inform consent form from adult patients and from parents and legal guardians for minor children

Exclusion Criteria:

  • Active viral infection, especially chronic hepatitis B
  • previous salvage therapy for relapse
  • Prior or current history of severe allergy
  • Primary large B-cell lymphoma of the mediastinum
  • Isolated CNS relapse
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00180895

Locations
France
Institut Gustave Roussy
Villejuif, France, 94800
Sponsors and Collaborators
Gustave Roussy, Cancer Campus, Grand Paris
Hoffmann-La Roche
Investigators
Principal Investigator: Catherine Patte, MD Gustave Roussy, Cancer Campus, Grand Paris
  More Information

No publications provided

ClinicalTrials.gov Identifier: NCT00180895     History of Changes
Other Study ID Numbers: Rituximab childhood
Study First Received: September 12, 2005
Last Updated: September 7, 2006
Health Authority: France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)

Keywords provided by Gustave Roussy, Cancer Campus, Grand Paris:
Burkitt lymphoma
B-cell non Hodgkin lymphoma
B-cell ALL
Refractory
Relapse
Rituximab
Children

Additional relevant MeSH terms:
Burkitt Lymphoma
Lymphoma
Epstein-Barr Virus Infections
Herpesviridae Infections
DNA Virus Infections
Virus Diseases
Tumor Virus Infections
Lymphoma, Non-Hodgkin
Neoplasms by Histologic Type
Neoplasms
Lymphoma, B-Cell
Neoplasms, Experimental
Lymphoproliferative Disorders
Lymphatic Diseases
Immunoproliferative Disorders
Immune System Diseases
Rituximab
Immunologic Factors
Physiological Effects of Drugs
Pharmacologic Actions
Antirheumatic Agents
Therapeutic Uses
Antineoplastic Agents

ClinicalTrials.gov processed this record on April 16, 2014