BNHL-2015 for Children or Adolescents in China

Sponsor
Children's Cancer Group, China
Study ID
NCT02405676
Phase
PHASE2/PHASE3
Status
Active Not Recruiting

Conditions

  • Mature B-cell Non-Hodgkin Lymphoma

Eligibility Criteria

Sex
ALL
Age
N/A - 16 Years
Healthy Volunteers
Not accepted

Interventions

  • Prednisone,Vincristine, Cyclophosphamide — DRUG
    Prednisone 45mg/m2, D1\~7; Vincristine 1.5mg/m2(MAX 2mg), D1; Cyclophosphamide 300mg/m2, D1; 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, D1,8;
  • 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;
  • Rituximab — DRUG
    375mg/m2, 4 injections for patients in Risk group4; D0 of Protocol AA or BB;

Study Details

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.

Key Dates

Start date
Jan 1, 2015
Status verified
Mar 2026
Primary completion
Dec 31, 2023
Completion
Dec 31, 2029

Study Design

Enrollment
200 participants (estimated)
Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Other: Risk group 1
    Complete resection of stage I or II disease: 3 courses (A-B-A) and 3 intrathecal injections(Cytarabine/Methotrexate/Dexamethasone, age adjusted);
  • Other: Risk group2
    Not or incompletely resected stage I/II disease and LDH \<2 times NL: 5 courses (A--B--A--B--A) and 8 intrathecal injections;
  • Other: Risk group3
    Stage III with high LDH \< 4 times NL, or Stage I,II with LDH \>=2 times NL: Preface followed by 6 courses (P(Cyclophosphamide/Vincristine/Prednisone)-A-BB-AA-BB-AA-BB) and 13 intrathecal injections; Dosage of Cytarabine, Methotrexate and Etoposide was increased in AA or BB compared with A or B. Vindelsine was used in AA/BB instead of Vincristine in A/B.
  • Other: Risk group4
    Stage III with LDH≥4N, or Stage IV, or B-AL: Preface followed by 4 dose of rituximab (375mg/m2) combined 6 courses of chemotherapy, together with 13 intrathecal injections: P-A-(Rituximab)BB-(Rituximab)AA-(Rituximab)BB-(Rituximab)AA-BB; rituximab is at D0 of each course.

Primary Outcome Measure

Event free survival [ Time Frame: 2 year ]

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