Non-Hodgkin Lymphoma
Conditions
Interventions
Rituximab
Sponsors
Institut Gustave Roussy
Eligibility
Age
No minimum to 17 Years
Inclusion criteria
Inclusion criteria: HISTOLOGY AND STAGING DISEASE, Phase III study: , -Histologically or cytologically proven B-cell malignancies, either Burkitt lymphoma or B-AL (
Exclusion criteria
Exclusion criteria: -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., -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., -Past or current anti-cancer treatment except corticosteroids of less than, 7 days duration in total., -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 randomisation. Contact the national co-investigator for further advice if necessary., - Hepatitis B carrier status history of HBV or positive serology
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Primary endpoint: Event Free Survival (EFS): Minimum time to death from any cause, presence of viable cells in residue after 6th DA-EPOCH course, relapse, progressive disease, or second malignancy measured from registration. | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary endpoints: - Survival (S): Time to death from any cause, measured from the time of registration - Complete Remission Rate at the assessment time - Acute (at each course) and long term toxicity: toxic deaths, adverse events of NCI-CTC V4 (non haematological toxicity grade*3, infections grade 3 to 5), cardiac toxicity (CTC grade 2-5 and abnormal left ventricular ejection fraction (LV-EF) or abnormal left ventricular shortening fraction (LV-SF)), number of platelets transfusion and of red cells transfusion, intensive care unit admission, rituximab infusion reactions. According to the recommendations of several authors (Steinherz 1992, Kremer-Van Dalen 2006) the cardiotoxicity is defined as following: LV-EF 20 % of baseline for one of these two criteria. - Immune reconstitution assessed by Ig (G, A and M) level and lymphocyte counts at 1 year and every year during follow-up until normal level, post vaccination antibody levels (tetanus, polio, diphtheria, haemophilus influenza and pneumococcus) and need for immunoglobulin infusion. | — |
Countries
Netherlands
Outcome results
None listed