Inter-groep studie voor de behandeling van kinderen en adolescenten met een B-cel non-Hodgkin lymfoom of B-ALL: Beoordeling van de werkzaamheid en veiligheid van rituximab bij patiënten met een hoog risico.
- Conditions
- childhood B-cell lymphoma childhood PMLBLB-cel non-Hodgkin lymfoom (B-NHL) bij kinderenB-cel acute lymfatische leukemie (B-ALL) bij kinderen
- Registration Number
- NL-OMON21840
- Lead Sponsor
- Institut Gustave Roussy114, rue Edouard Vaillant94 805 - Villejuif France
- Brief Summary
/A
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Pending
- Sex
- Not specified
- Target Recruitment
- 640
Inclusion Criteria
Children and adolescents aged until 18 years with untreated advanced stage B-cell NHL or B-AL.
Exclusion Criteria
HISTOLOGY AND STAGING DISEASE:
1. Follicular lymphoma, MALT and nodular marginal zone are not included into this therapeutic study;
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Event Free Survival.
- Secondary Outcome Measures
Name Time Method 1. Overall Survival;<br /><br>2. Complete Remission Rate at the assessment time;<br /><br>3. For group B patients: Response in 3 categories:<br /><br>A. CR at assessment time (after CYM1);<br /><br>B. Slow responder = CR at CYVE2 but not after CYM1;<br /><br>C. No CR.<br /><br>4. Acute (at each course) and long term toxicity;<br /><br>5. Immune reconstitution.