BNHL-2015 for Children or Adolescents in China

• Status: Active, not recruiting
• Trial end date: 2024-12-01
• Target enrollment: 0
• Participant gender: All

Summary

The purpose of this study is to test whether adding 4 injections of rituximab and increasing the intensity of chemotherapy regimens in advanced patients can improve the EFS compared with the historical study CCCG-NHL-2010.

• Phase: Phase 2/Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Children's Cancer Group, China
• Collaborators: Children's Hospital Of Soochow University; Children’s Hospital of Sochow University, China; Nanjing Children's Hospital; Qilu Hospital; Qilu Hospital of Shandong University; Tianjin Medical University Cancer Institute and Hospital; Tongji Hospital; Tongji Hospital affiliated to Tongji Medical College of Huazhong University of Science & Technology, China; West China Second University Hospital; Xiangya Hospital of Central South University
• Treatments: Cyclophosphamide; Cytarabine; Etoposide; Etoposide phosphate; Ifosfamide; Isophosphamide mustard; Methotrexate; Prednisone; Rituximab; Vincristine

Criteria

Inclusion Criteria:

• Histology or cytologically confirmed matureB-cell NHL/AL(Burkitt, DLBCL, PMLBL,or aggressive mature B-cell NHL non other specified or specifiable)

• Able to comply with scheduled follow-up and with management of toxicity

• Signed informed consent

Exclusion Criteria:

• 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.

Exclusion criteria related to rituximab:

• Tumor cell negative for CD20.

• Prior exposure to rituximab.

• Hepatitis B carrier status history of HBV or positive serology.