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A phase 2 trial of Doxorubicin, Cyclophosphamide, Methotrexate, Rasburicase, Leucovorin, Prednisone, Filgrastim, Rituximab, Cytarabine, Etoposide and Vincristine in Burkitt lymphoma and Acute lymphoblastic leukaemia, run by Children's Oncology Group, completed.
Rituximab, Rasburicase, and Combination Chemotherapy in Treating Young Patients With Newly Diagnosed Advanced B-Cell Leukemia or Lymphoma is a phase 2 interventional study registered as NCT00057811 by Children's Oncology Group, with 97 participants recorded, started 2004-06 and reaching its primary completion in 2009-10. Interventions recorded: doxorubicin hydrochloride, cyclophosphamide, methotrexate, rasburicase, leucovorin calcium, prednisone, methylprednisolone, filgrastim, rituximab, cytarabine, etoposide, vincristine sulfate, hydrocortisone sodium succinate, laboratory biomarker analysis. Conditions recorded: Childhood Burkitt Lymphoma, Childhood Diffuse Large Cell Lymphoma, Childhood Immunoblastic Large Cell Lymphoma, Stage I Childhood Large Cell Lymphoma, Stage I Childhood Small Noncleaved Cell Lymphoma, Stage II Childhood Large Cell Lymphoma, Stage II Childhood Small Noncleaved Cell Lymphoma, Stage III Childhood Large Cell Lymphoma, Stage III Childhood Small Noncleaved Cell Lymphoma, Stage IV Childhood Large Cell Lymphoma, Stage IV Childhood Small Noncleaved Cell Lymphoma, Untreated Childhood Acute Lymphoblastic Leukemia.
Linked to the drug Rasburicase because the registry names it among its interventions and Burkitt lymphoma and Acute lymphoblastic leukaemia among its conditions. Registry record only: no result has been read by an editor.
Numbers are from the trial as recorded here; see the source links in the table below. This is orientation, not medical advice: ask your team how closely the trial population matches you.
97 enrolled.
95% CI 11 to 40; Figures from the ClinicalTrials.gov results section (first posted 2014-08-22), not from a publication · 95% CI 35 to 93
Source| Endpoint | Arm | n | Value | HR (95% CI) | p | Source |
|---|---|---|---|---|---|---|
| Minimal Residual Diseaseprimary | Group B (Chemotherapy, Protective Therapy, Monoclonal Antib.) | 32 | 22% | - | - | link |
| Group C (Chemotherapy, Monoclonal Antibody Therapy) | 10 | 70% |
Shares Filgrastim (G-CSF), Cytarabine, Leucovorin (folinic acid), Methotrexate and the tag pipeline.
Shares Cytarabine, Methotrexate, Prednisone, Vincristine and the tag pipeline.
Shares Cytarabine, Leucovorin (folinic acid), Methotrexate, Prednisone and the tag pipeline.
Shares Cytarabine, Methotrexate, Vincristine, Rituximab and the tag pipeline.
Shares Cytarabine, Methotrexate, Prednisone, Vincristine and the tag pipeline.
Shares Prednisone, Vincristine, Rituximab, Doxorubicin and the tag pipeline.
Shares Cytarabine, Methotrexate, Vincristine, Etoposide and the tag pipeline.
Shares Cytarabine, Prednisone, Vincristine, Etoposide and the tag pipeline.