At a glance
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Intensive Chemotherapy Combined With Early, Adequate, and Intensive Use of Rituximab for Aggressive B-NHL in Children and Adolescents
In Brief
A Phase 2 clinical trial evaluating Cyclophosphamide, Vincristine, Cytarabine, Doxorubincin, Prednisone, Drug: Ifosphamide, Etoposide, Methotrexate, Vincristine, Prednisone, and 4 other interventions for Mature B-cell Non-Hodgkin Lymphoma. Currently recruiting, targeting 87 participants across 1 site.
Detailed Summary
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.
Study Details
Timeline
Arms & Interventions
Complete resection of stage I or II disease: 3 courses (A-B-A) and 3 intrathecal injections(Cytarabine/Methotrexate/Dexamethasone, age adjusted);
Not or incompletely resected stage I/II disease and LDH \<2ULN: 5 courses (A--B--A--B--A) and 8 intrathecal injections;
Stage III with LDH \< 2 ULN, or Stage I,II with LDH in 2 to 4 ULN : Preface followed by 6 courses (P(Cyclophosphamide/Vincristine/Prednisone)-AA-BB-AA-BB-AA-BB) and 13 intrathecal injections(16 intrathecal injections with CNS2-3)
Stage III with LDH≥2ULN, or Stage IV, or B-AL: Preface followed by 6 dose of rituximab (375mg/m2) combined 6 courses of chemotherapy, together with 13 intrathecal injections((16 intrathecal injections with CNS2-3): P-(Rituximab-Rituximab)AA-(Rituximab-Rituximab)BB-(Rituximab)AA-(Rituximab)BB-AA-BB; stage IV or B-AL with LDH≥5ULN:P-(Rituximab-Rituximab)AA-(Rituximab-Rituximab)BB-(Rituximab)AA-(Rituximab)BB-AA-BB-AA-BB, together with 17 intrathecal injections((21 intrathecal injections with CNS2-3)
Interventions
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;
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 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 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 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 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 45mg/m2, D1\~7; Vincristine 1.5mg/m2(MAX 2mg), D1; Cyclophosphamide 300mg/m2, D1; Intrathecal injection, D1