BNHL-2015 for Children or Adolescents in China

Phase 2

Active, not recruiting

• Conditions: Mature B-cell Non-Hodgkin Lymphoma
• Interventions: Drug: Prednisone,Vincristine, Cyclophosphamide; Drug: Cyclophosphamide, Vincristine, Cytarabine, Doxorubincin, Prednisone; Drug: Ifosphamide, Etoposide, Methotrexate, Vincristine, Prednisone; Drug: Cyclophosphamide, Vindelsine, Cytarabine, Doxorubincin, Prednisone; Drug: Ifosphamide, Etoposide, Methotrexate, Vindelsine, Prednisone; Drug: Rituximab

• Registration Number: NCT02405676
• Lead Sponsor: Children's Cancer Group, China

Brief Summary

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.

Detailed Description

In our previous study (CCCG-NHL-2010), two-year EFS was 100% for Stage I, 91.3% ± 6.1% for Stage II, 75.8% ± 4.4% for Stage III, 56.3% ± 13.5% for Stage IV, and 36.4% ± 14.5% for B-AL, respectively. To improve survival for pediatric patients with B-NHL/B-AL, the investigators launched a new study in China. Compared with our previous treatment regimens (CCCG-2010), patients with stage III and LDH\>4 times NL, any stage IV or B-AL were stratified into R4. The dose of methotrexate was increased to 5000mg/m2 for patients in R3 or R4 (previously 3000mg/m2). Four injections of rituximab was added to the chemotherapy for patients in R4. Our aim is to test whether adding rituximab or high dose of methotrexate (5000mg/m2) would improving 2-year EFS for patients in advanced groups.

Study Timeline

• Study Start: 2015-01
• Study First Submitted: 2015-02-26
• Study First Submitted QC: 2015-03-28
• Study First Posted: 2015-04-01
• Primary Completion: 2023-12-31
• Status Verified: 2024-02
• Last Update Submitted: 2024-02-09
• Last Update Posted: 2024-02-12
• Study Completion: 2024-12

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: All
• Target Recruitment: 200

Inclusion Criteria

• Histology or cytologically confirmed matureB-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

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Exclusion Criteria

• 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.

Exclusion criteria related to rituximab:

• Tumor cell negative for CD20.
• Prior exposure to rituximab.
• Hepatitis B carrier status history of HBV or positive serology.

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Risk group4	Prednisone,Vincristine, Cyclophosphamide	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.
Risk group 1	Cyclophosphamide, Vincristine, Cytarabine, Doxorubincin, Prednisone	Complete resection of stage I or II disease: 3 courses (A-B-A) and 3 intrathecal injections(Cytarabine/Methotrexate/Dexamethasone, age adjusted);
Risk group3	Ifosphamide, Etoposide, Methotrexate, Vindelsine, Prednisone	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.
Risk group4	Cyclophosphamide, Vincristine, Cytarabine, Doxorubincin, Prednisone	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.
Risk group 1	Ifosphamide, Etoposide, Methotrexate, Vincristine, Prednisone	Complete resection of stage I or II disease: 3 courses (A-B-A) and 3 intrathecal injections(Cytarabine/Methotrexate/Dexamethasone, age adjusted);
Risk group2	Cyclophosphamide, Vincristine, Cytarabine, Doxorubincin, Prednisone	Not or incompletely resected stage I/II disease and LDH \<2 times NL: 5 courses (A--B--A--B--A) and 8 intrathecal injections;
Risk group3	Cyclophosphamide, Vincristine, Cytarabine, Doxorubincin, Prednisone	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.
Risk group3	Cyclophosphamide, Vindelsine, Cytarabine, Doxorubincin, Prednisone	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.
Risk group2	Ifosphamide, Etoposide, Methotrexate, Vincristine, Prednisone	Not or incompletely resected stage I/II disease and LDH \<2 times NL: 5 courses (A--B--A--B--A) and 8 intrathecal injections;
Risk group3	Prednisone,Vincristine, Cyclophosphamide	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.
Risk group4	Ifosphamide, Etoposide, Methotrexate, Vindelsine, Prednisone	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.
Risk group4	Cyclophosphamide, Vindelsine, Cytarabine, Doxorubincin, Prednisone	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.
Risk group4	Rituximab	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 Measures

Name	Time	Method
Event free survival	2 year

Secondary Outcome Measures

Name	Time	Method
Overall survival	5 year

Trial Locations

Locations (1)

West China Second University Hospital of Sichuan University; 🇨🇳 Chengdu, Sichuan, China