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

First listed
Apr 1, 2015
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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