Health TrialsbyHealthPanel

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

ConditionMature B-cell Non-Hodgkin Lymphoma
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

This trial does not accept healthy volunteers

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

Design model

Sequential

Treatments tested in this trial

  • Cyclophosphamide, Vincristine, Cytarabine, Doxorubincin, Prednisone

    Drug

    Cyclophosphamide 800mg/m2, D1, then 200mg/m2, D2\~4;Vincristine 1.5mg/m2 (MAX 2mg), D1; Cytarabine 1g/m2/dose, (2 doses, 12-hour interval), D4; Doxorubincin 20mg/m2, D2,3; Prednisone 60mg/m2, D1\~7;Intrathecal injection, D1;

  • Drug: Ifosphamide, Etoposide, Methotrexate, Vincristine, Prednisone

    Drug

    Ifosphamide 1.2g/m2, D1\~5; Etoposide, 60mg/m2, D3\~5; Methotrexate, 0.5g/m2, D1;Vincristine 1.5mg/m2 (MAX 2mg), D1; Prednisone 60mg/m2, D1\~7;Intrathecal injection, D1;

  • Cyclophosphamide, Vincristine, Cytarabine, Doxorubincin, Prednisone

    Drug

    Cyclophosphamide 800mg/m2, D1, then 200mg/m2, D2\~4;Vincristine 1.5mg/m2 (MAX 2mg), D1; Cytarabine 1g/m2/dose, (2 doses, 12-hour interval), D4;Doxorubincin 20mg/m2, D2,3; Prednisone 60mg/m2, D1\~7;Intrathecal injection, D1,8;

  • Ifosphamide, Etoposide, Methotrexate, Vincristine, Prednisone

    Drug

    Ifosphamide 1.2g/m2, D1\~5; Etoposide, 60mg/m2, D3\~5; Methotrexate, 0.5g/m2, D1;Vincristine 1.5mg/m2 (MAX 2mg), D1; Prednisone 60mg/m2, D1\~7;Intrathecal injection, D1

  • Cyclophosphamide, Vindelsine, Cytarabine, Doxorubincin, Prednisone

    Drug

    Cyclophosphamide 800mg/m2, D1, then 200mg/m2, D2\~4; Vindelsine 3mg/m2 (MAX 5mg), D1; Cytarabine 2g/m2/dose, (2 doses, 12-hour interval), D4; Doxorubincin 20mg/m2, D2,3; Prednisone 60mg/m2, D1\~7;Intrathecal injection, D1,4(CNS2-3),8

  • Ifosphamide, Etoposide, Methotrexate, Vindelsine, Prednisone

    Drug

    Ifosphamide 1.2g/m2, D1\~5; Etoposide, 100mg/m2, D3\~5; Methotrexate, 5g/m2, D1;Vindelsine 3mg/m2 (MAX 5mg), D1; Prednisone 60mg/m2, D1\~7;Intrathecal injection, D1,8

  • Prednisone,Vincristine, Cyclophosphamide

    Drug

    Prednisone 45mg/m2, D1\~7; Vincristine 1.5mg/m2(MAX 2mg), D1; Cyclophosphamide 300mg/m2, D1; Intrathecal injection, D1

Treatment groups

87 Participants
are divided into 4 treatment groups
Group A: Risk group 1Other 2 interventions
Group B: Risk group 2Other 2 interventions
Group C: Risk group 3Other 3 interventions
Group D: Risk group 4Other 3 interventions

Trial outcomes

Primary outcomes

1

Event free survival

Time frame
3 years

Secondary outcomes

1

Overall survival

Time frame
3 years

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

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

Source ClinicalTrials.gov
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