B-cell NHL or Mature B-cell Acute Leukemia
Conditions
Interventions
The patients will receive a total of 6 injections of the antibody: 2 at 48h interval at D-2 and D1 of the 2 COPADM courses and one injection at D1 of the 2 consolidation courses either CYM (B) or CYVE
Sponsors
Japanese Pediatric Leukemia/Lymphoma Study Group (JPLSG)
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Histology and staging disease - 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. - Stage III with elevated LDH level, (LDH > twice the institutional upper limit of the adult normal values) or any stage IV or B-AL.
Exclusion criteria
Exclusion criteria: Histology and staging disease - Follicular lymphoma, MALT and nodular marginal zone are not included into this therapeutic study - In phase II study (PMLBL) patients with CNS involvement are not eligible. General conditions - Patients with congenital immunodeficiency, chromosomal breakage syndrome, prior organ transplantation, previous malignancy of any type, or known positive HIV serology. - Evidence of pregnancy or lactation period. - There will be no exclusion criteria based on organ function. Dosing guidelines for organ dysfunction are provided in annexe D1. Prior therapy Past or current anti-cancer treatment except corticosteroids of less than 7 days duration in total. Exclusion criteria related to rituximab - 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). - Prior exposure to rituximab. - Severe active viral infection, especially hepatitis B. - Severe infection (such as sepsis, pneumonia, etc.) should be clinically controlled at the time of registration. Contact the national co- investigator for further advice if necessary. - Hepatitis B carrier status history of HBV or positive serology. A patient is considered as HBV carrier or to have (had) HBV infection in case of: - Unimmunized and HBsAg and/or anti-HBs antibody and/or anti- HBc antibody positive, - Immunized and HBsAG and/or anti-HBc antibody positive. Others - Participation in another investigational drug clinical trial. - Patients who, for any reason, are not able to comply with the national legislation.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Event free survival | — |
Secondary
| Measure | Time frame |
|---|---|
| - Survival - Complete remission rate - Acute and long term toxicity - Immune reconstitution assessed by immunogloburin level and lymphocyte counts | — |
Countries
Japan
Contacts
Public ContactTomoo Osumi
National Center for Child Health and Development Division of Leukemia and Lymphoma, Children's Cancer Center
Outcome results
None listed