BNHL-2015 for Children or Adolescents in China

Children's Cancer Group, China

Status and phase: Active, not recruiting; Phase 3; Phase 2

Conditions: Mature B-cell Non-Hodgkin Lymphoma

Treatments: Drug: Ifosphamide, Etoposide, Methotrexate, Vincristine, Prednisone; Drug: Cyclophosphamide, Vindelsine, Cytarabine, Doxorubincin, Prednisone; Drug: Rituximab; Drug: Ifosphamide, Etoposide, Methotrexate, Vindelsine, Prednisone; Drug: Cyclophosphamide, Vincristine, Cytarabine, Doxorubincin, Prednisone; Drug: Prednisone,Vincristine, Cyclophosphamide

Study type: Interventional

Funder types: Other; NETWORK

Identifiers

NCT02405676

CCCG-BNHL-2015

Details and patient eligibility

About

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.

Full 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.

Enrollment: 200 estimated patients

Sex: All

Ages: Under 16 years old

Volunteers: No Healthy Volunteers

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

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.

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Single Group Assignment

Masking: None (Open label)

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200 participants in 4 patient groups

Risk group 1

Other group

Description:

Complete resection of stage I or II disease: 3 courses (A-B-A) and 3 intrathecal injections(Cytarabine/Methotrexate/Dexamethasone, age adjusted);

Treatment:

Drug: Cyclophosphamide, Vincristine, Cytarabine, Doxorubincin, Prednisone

Drug: Ifosphamide, Etoposide, Methotrexate, Vincristine, Prednisone

Risk group2

Other group

Description:

Not or incompletely resected stage I/II disease and LDH \<2 times NL: 5 courses (A--B--A--B--A) and 8 intrathecal injections;

Treatment:

Drug: Cyclophosphamide, Vincristine, Cytarabine, Doxorubincin, Prednisone

Drug: Ifosphamide, Etoposide, Methotrexate, Vincristine, Prednisone

Risk group3

Other group

Description:

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.

Treatment:

Drug: Prednisone,Vincristine, Cyclophosphamide

Drug: Cyclophosphamide, Vincristine, Cytarabine, Doxorubincin, Prednisone

Drug: Ifosphamide, Etoposide, Methotrexate, Vindelsine, Prednisone

Drug: Cyclophosphamide, Vindelsine, Cytarabine, Doxorubincin, Prednisone

Risk group4

Other group

Description:

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.

Treatment:

Drug: Prednisone,Vincristine, Cyclophosphamide

Drug: Cyclophosphamide, Vincristine, Cytarabine, Doxorubincin, Prednisone

Drug: Ifosphamide, Etoposide, Methotrexate, Vindelsine, Prednisone

Drug: Rituximab

Drug: Cyclophosphamide, Vindelsine, Cytarabine, Doxorubincin, Prednisone