Clareo Health | Intergroup Randomized Trial for Children or Adolescents With B-Cell Non Hodgkin Lymphoma or B-Acute Leukemia: Rituximab Evaluation in High Risk Patients
Intergroup Randomized Trial for Children or Adolescents With B-Cell Non Hodgkin Lymphoma or B-Acute Leukemia: Rituximab Evaluation in High Risk Patients
Saves the questions and what to expect into your notes, next to the visit they belong to.
Keep this study
Lead
Gustave Roussy, Cancer Campus, Grand Paris
With
Children's Oncology Group
Age
0–17
Sex
ALL
Healthy volunteers
Not accepted
You may be eligible if
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 ("B-high"), \[LDH \> twice the institutional upper limit of the adult normal values (\> Nx2)\] or any stage IV or B-AL.
6 months to less than 18 years of age at the time of consent.
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.
Complete initial work-up within 8 days prior to treatment that allows definite staging.
Able to comply with scheduled follow-up and with management of toxicity.
Signed informed consent from patients and/or their parents or legal guardians
You may not be if
Follicular lymphoma, MALT and nodular marginal zone are not included into this therapeutic study
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.
Past or current anti-cancer treatment except corticosteroids during less than one week.
Tumor cell negative for CD20
Prior exposure to rituximab.
Severe active viral infection, especially hepatitis B.
Hepatitis B carrier status history of HBV or positive serology.
Participation in another investigational drug clinical trial.
Patients who, for any reason, are not able to comply with the national legislation.
