childhood B-cell lymphoma childhood PMLBL B-cel non-Hodgkin lymfoom (B-NHL) bij kinderen B-cel acute lymfatische leukemie (B-ALL) bij kinderen
Conditions
Interventions
Patients will be randomized to standard treatment or standard treatment with Rituximab. Patients in the intervention group will receive 6 injections of rituximab to a standard LMB chemotherapy regimen
Sponsors
Institut Gustave Roussy
114, rue Edouard Vaillant
94 805 - Villejuif
France
Eligibility
Inclusion criteria
Inclusion criteria: Children and adolescents aged until 18 years with untreated advanced stage B-cell NHL or B-AL. HISTOLOGY AND STAGING DISEASE: Phase III study: 1. Histologically or cytologically proven B-cell malignancies, either Burkitt lymphoma or B-AL (=Burkitt leukaemia = L3-AL) or diffuse large B-cell NHL or aggressive mature B-cell NHL non other specified or specifiable; 2. Stage III with elevated LDH level (“B-high”), [LDH > twice the institutional upper limit of the adult normal values (> Nx2)] or any stage IV or B-AL. Phase II study: 1. Histolo-cytologically proven PMLBL; 2. PMLBL without CNS involvement. GENERAL CONDITIONS: 1. 6 months to less than 18 years of age at the time of consent; 2. Males and females of reproductive potential must agree to use an effective contraceptive method during the treatment, and after the end of treatment: during twelve months for women, taking into account the characteristics of rituximab and during five months for men, taking into account the characteristics of methotrexate. INITIAL WORK-UP: Complete initial work-up within 8 days prior to treatment. OTHERS: 1. Able to comply with scheduled follow-up and with management of toxicity; 2. Signed informed consent from patients and/or their parents or legal guardians.
Exclusion criteria
Exclusion criteria: HISTOLOGY AND STAGING DISEASE: 1. Follicular lymphoma, MALT and nodular marginal zone are not included into this therapeutic study; 2. In phase II study (PMLBL) patients with CNS involvement are not eligible. GENERAL CONDITIONS: 1. Patients with congenital immunodeficiency, chromosomal breakage syndrome, prior organ transplantation, previous malignancy of any type, or known positive HIV serology; 2. Evidence of pregnancy or lactation period; 3. There will be no exclusion criteria based on organ function. PRIOR THERAPY: Past or current anti-cancer treatment except corticosteroids during less than one week. EXCLUSION CRITERIA RELATED TO RITUXIMAB: 1. Tumor cell negative for CD20 (absence of result due to technical problems in the presence of other characteristics suggestive of BL/DLBCL, including genetic and phenotypic features, is not an exclusion criteria); 2. Prior exposure to rituximab; 3. Severe active viral infection, especially hepatitis B. Severe infection (such as sepsis, pneumonia, etc..) should be clinically controlled at the time of randomisation. Contact the national co-investigator for further advice if necessary; 4. Hepatitis B carrier status history of HBV or positive serology.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Event Free Survival. | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Overall Survival; 2. Complete Remission Rate at the assessment time; 3. For group B patients: Response in 3 categories: A. CR at assessment time (after CYM1); B. Slow responder = CR at CYVE2 but not after CYM1; C. No CR. 4. Acute (at each course) and long term toxicity; 5. Immune reconstitution. | — |
Contacts
Public ContactM. Mierlo, van
SKION Leyweg 299
Outcome results
None listed