Multi-center Trial for Children with B-cell NHL or B-AL: Evaluation of Rituximab Efficacy and Safety in High Risk Patients (JPLSG B-NHL-14)

Not Applicable

• Conditions: B-cell NHL or Mature B-cell Acute Leukemia

• Registration Number: JPRN-UMIN000021286
• Lead Sponsor: Japanese Pediatric Leukemia/Lymphoma Study Group (JPLSG)

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2016-04-01
• Study Completion: 2023-09-30
• Last Update Posted: 17 October 2023

Recruitment & Eligibility

• Status: Complete: follow-up continuing
• Sex: All
• Target Recruitment: 46

Inclusion Criteria

Not provided

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.

Study & Design

• Study Type: Interventional
• Study Design: Not specified