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

NCT00180895 | Terminated Phase 2

• 1 other identifier: Rituximab childhood
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

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

Conditions

Burkitt Lymphoma

Keywords

Burkitt lymphoma; B-cell non Hodgkin lymphoma; B-cell ALL; Refractory; Relapse; Rituximab; Children

Outcome Measures

Primary Outcomes (1)

• Rate of patients achieving at least objective response after 2 courses of rituximab

Secondary Outcomes (4)

• 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

Interventions

Rituximab DRUG

Eligibility Criteria

• Age: 6 Months - 20 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Gustave Roussy, Cancer Campus, Grand Paris: lead
• Hoffmann-La Roche: collaborator

Study Sites (1)

Institut Gustave Roussy

Villejuif, 94800, France

Location

MeSH Terms

Conditions

Burkitt Lymphoma; Lymphoma, B-Cell; Recurrence

Interventions

Rituximab

Condition Hierarchy (Ancestors)

Epstein-Barr Virus Infections; Herpesviridae Infections; DNA Virus Infections; Virus Diseases; Infections; Tumor Virus Infections; Lymphoma, Non-Hodgkin; Lymphoma; Neoplasms by Histologic Type; Neoplasms; Lymphoproliferative Disorders; Lymphatic Diseases; Hemic and Lymphatic Diseases; Immunoproliferative Disorders; Immune System Diseases; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Antibodies, Monoclonal, Murine-Derived; Antibodies, Monoclonal; Antibodies; Immunoglobulins; Immunoproteins; Blood Proteins; Proteins; Amino Acids, Peptides, and Proteins; Serum Globulins; Globulins

Study Officials

• Catherine Patte, MD

  Gustave Roussy, Cancer Campus, Grand Paris

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: September 12, 2005
• First Posted: September 16, 2005
• Study Start: June 1, 2004
• Last Updated: September 11, 2006

Record last verified: 2006-09

Locations

FR (1)