Chemotherapy With Rituximab for Aggressive B-NHL in Children and Adolescents

Trial statusRecruiting
Trial phasePhase 2, Phase 3
Trial typeInterventional
Biological sexAll
AgeUp to 18
SponsorChildren's Cancer Group, China

About this trial

The purpose of this study is to test whether intensive chemotherapy combined with early, adequate, and intensive use of Rituximab for aggressive B-NHL in children and adolescents can improve the EFS and OS compared with the historical study CCCG-BNHL-2015.

Eligibility criteria

Qualifiers

Histology or cytologically confirmed mature B-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

Disqualifiers

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

Trial design

Treatments tested in this trial

  • Cyclophosphamide, Vincristine, Cytarabine, Doxorubincin, Prednisone
  • Drug: Ifosphamide, Etoposide, Methotrexate, Vincristine, Prednisone
  • Cyclophosphamide, Vincristine, Cytarabine, Doxorubincin, Prednisone
  • Ifosphamide, Etoposide, Methotrexate, Vincristine, Prednisone
  • Cyclophosphamide, Vindelsine, Cytarabine, Doxorubincin, Prednisone
  • Ifosphamide, Etoposide, Methotrexate, Vindelsine, Prednisone
  • Prednisone,Vincristine, Cyclophosphamide

Treatment groups

87 Participants
are divided into 4 treatment groups

Sponsors and collaborators

Children's Cancer Group, China

Lead sponsor

Shanghai Children's Medical Center

Collaborator

Nanjing Children's Hospital

Collaborator

Children's Hospital of Soochow University

Collaborator

West China Second University Hospital

Collaborator

Qilu Hospital of Shandong University

Collaborator

Tianjin Medical University Cancer Institute and Hospital

Collaborator

Xiangya Hospital of Central South University

Collaborator

Wuhan TongJi Hospital

Collaborator