BNHL-2015 for Children or Adolescents in China
Study Details
Study Description
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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
Phase 2/Phase 3 |
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 Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| 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); |
Drug: Cyclophosphamide, Vincristine, Cytarabine, Doxorubincin, Prednisone
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;
Other Names:
Drug: Ifosphamide, Etoposide, Methotrexate, Vincristine, Prednisone
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;
Other Names:
|
| 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; |
Drug: Cyclophosphamide, Vincristine, Cytarabine, Doxorubincin, Prednisone
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;
Other Names:
Drug: Ifosphamide, Etoposide, Methotrexate, Vincristine, Prednisone
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;
Other Names:
|
| 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. |
Drug: Prednisone,Vincristine, Cyclophosphamide
Prednisone 45mg/m2, D1~7; Vincristine 1.5mg/m2(MAX 2mg), D1; Cyclophosphamide 300mg/m2, D1; Intrathecal injection, D1;
Other Names:
Drug: Cyclophosphamide, Vincristine, Cytarabine, Doxorubincin, Prednisone
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;
Other Names:
Drug: Cyclophosphamide, Vindelsine, Cytarabine, Doxorubincin, Prednisone
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;
Other Names:
Drug: Ifosphamide, Etoposide, Methotrexate, Vindelsine, Prednisone
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;
Other Names:
|
| 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. |
Drug: Prednisone,Vincristine, Cyclophosphamide
Prednisone 45mg/m2, D1~7; Vincristine 1.5mg/m2(MAX 2mg), D1; Cyclophosphamide 300mg/m2, D1; Intrathecal injection, D1;
Other Names:
Drug: Cyclophosphamide, Vincristine, Cytarabine, Doxorubincin, Prednisone
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;
Other Names:
Drug: Cyclophosphamide, Vindelsine, Cytarabine, Doxorubincin, Prednisone
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;
Other Names:
Drug: Ifosphamide, Etoposide, Methotrexate, Vindelsine, Prednisone
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;
Other Names:
Drug: Rituximab
375mg/m2, 4 injections for patients in Risk group4; D0 of Protocol AA or BB;
|
Outcome Measures
Primary Outcome Measures
- Event free survival [2 year]
Secondary Outcome Measures
- Overall survival [5 year]
Eligibility Criteria
Criteria
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
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Patients with congenital immunodeficiency, chromosomal breakage syndrome, prior organ transplantation, previous malignancy of any type, or known positive HIV serology.
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-Evidence of pregnancy or lactation period.
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Past or current anti-cancer treatment except corticosteroids during less than one week.
Exclusion criteria related to rituximab:
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Tumor cell negative for CD20.
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Prior exposure to rituximab.
-
Hepatitis B carrier status history of HBV or positive serology.
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | West China Second University Hospital of Sichuan University | Chengdu | Sichuan | China |
Sponsors and Collaborators
- Children's Cancer Group, China
- Tongji Hospital affiliated to Tongji Medical College of Huazhong University of Science & Technology, China
- Nanjing Children's Hospital
- West China Second University Hospital
- Xiangya Hospital of Central South University
- Qilu Hospital of Shandong University
- Children's Hospital Of Soochow University
- Tianjin Medical University Cancer Institute and Hospital
Investigators
- Principal Investigator: Yi-Jin Gao, MD, Shanghai Children's Medical Center
Study Documents (Full-Text)
None provided.More Information
Publications
- CCCG-BNHL-2015