INTERGROUP TRIAL FOR CHILDREN OR ADOLESCENTS WITH B-CELL NHL OR B-AL: EVALUATION OF RITUXIMAB EFFICACY AND SAFETY IN HIGH RISK PATIENTS

Active, not recruiting

Conditions: ntreated children or adolescents with PMLBL
MedDRA version: 14.1Level: PTClassification code 10036710Term: Primary mediastinal large B-cell lymphomaSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Therapeutic area: Diseases [C] - Cancer [C04]

Registration Number: EUCTR2010-019224-31-IT

Lead Sponsor: A.I.E.O.P. - ASSOCIAZIONE ITALIANA EMATOLOGIA ONCOLOGIA PEDIATRICA

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Not Recruiting

Sex: All

Target Recruitment: 40

Inclusion Criteria

- Histolo-cytologically proven PMLBL. - PMLBL without CNS involvement. GENERAL CONDITIONS - 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. INITIAL WORK-UP - Complete initial work-up within 8 days prior to treatment. OTHERS - Able to comply with scheduled follow-up and with management of toxicity. - Signed informed consent from patients and/or their parents or legal guardians.
Are the trial subjects under 18? yes
Number of subjects for this age range: 5
F.1.2 Adults (18-64 years) no
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range

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. PRIOR THERAPY - Past or current anti-cancer treatment except corticosteroids during less than one week. 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 randomisation. Contact the national co-investigator for further advice if necessary. - Hepatitis B carrier status history of HBV or positive serology.