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Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ClinicalTrials.gov |
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Last refreshed on:
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19 February 2015 |
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Main ID: |
NCT00180895 |
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Date of registration:
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12/09/2005 |
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Prospective Registration:
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No |
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Primary sponsor: |
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Public title:
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Rituximab in Children and Adolescents With Relapsed and Refractory B-Cell NHL/L3ALL
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Scientific title:
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A Phase II Study of Mabthera (Rituximab) in Children and Adolescents With Relapsed and Refractory B-Cell NHL/L3ALL |
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Date of first enrolment:
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June 2004 |
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Target sample size:
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40 |
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Recruitment status: |
Terminated |
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URL:
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http://clinicaltrials.gov/show/NCT00180895 |
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Study type:
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Interventional |
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Study design:
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Allocation: Non-Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
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Phase:
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Phase 2
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Countries of recruitment
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France
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Contacts
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Name:
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Catherine Patte, MD |
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Address:
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Telephone:
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Email:
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Affiliation:
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Gustave Roussy, Cancer Campus, Grand Paris |
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Key inclusion & exclusion criteria
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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
Age minimum:
6 Months
Age maximum:
20 Years
Gender:
Both
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Health Condition(s) or Problem(s) studied
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Burkitt Lymphoma
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Intervention(s)
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Drug: Rituximab
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Primary Outcome(s)
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Rate of patients achieving at least objective response after 2 courses of rituximab
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Secondary Outcome(s)
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Rate of objective response after 4 courses of rituximab
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Rate of initially responding patients who progressed during the second phase of treatment
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Pharmacokinetic evaluation in serum and CSF
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Toxicity
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Secondary ID(s)
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Rituximab childhood
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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Results
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Results available:
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Date Posted:
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Date Completed:
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URL:
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