INTERGROUP TRIAL FOR CHILDREN OR ADOLESCENTSWITH B-CELL NHL OR B-AL: EVALUATIONOF RITUXIMAB EFFICACY AND SAFETY IN HIGH RISK PATIENTS

• Conditions: untreated advanced stage B-cell NHL or B-AL.; MedDRA version: 14.0Level: PTClassification code 10006595Term: Burkitt's lymphomaSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps); MedDRA version: 14.0Level: LLTClassification code 10067070Term: Follicular B-cell non-Hodgkin's lymphomaSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps); MedDRA version: 14.0Level: LLTClassification code 10067194Term: Burkitt's leukemiaSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps); Therapeutic area: Diseases [C] - Cancer [C04]

• Registration Number: EUCTR2010-019224-31-ES
• Lead Sponsor: Institut Gustave Roussy

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2011-10-13
• Last Update Posted: 22 December 2015

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 640

Inclusion Criteria

HISTOLOGY AND STAGING DISEASE
Phase III study:
-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.
Phase II study:
-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: 640
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

-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 during less than one week.
-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

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified