Clinical trial · Interventional
Rituximab, Rasburicase, and Combination Chemotherapy in Treating Young Patients With Newly Diagnosed Advanced B-Cell Leukemia or Lymphoma
A Pilot Study To Determine The Toxicity Of The Addition Of Rituximab To The Induction And Consolidation Phases And The Addition Of Rasburicase To The Reduction Phase In Children With Newly Diagnosed Advanced B-Cell Leukemia/Lymphoma Treated With LMB/FAB Therapy
NCT00057811CI-TRIAL-00015655completedPhase 2Results postedClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
Phase II trial to study the effectiveness of combining rituximab and rasburicase with combination chemotherapy in treating young patients who have newly diagnosed advanced B-cell leukemia or lymphoma. Monoclonal antibodies such as rituximab can locate cancer cells and either kill them or deliver cancer-killing substances to them without harming normal cells. Drugs used in chemotherapy work in different ways to stop cancer cells from dividing so they stop growing or die. Combining more than one drug with rituximab may kill more cancer cells. Chemoprotective drugs such as rasburicase may protect kidney cells from the side effects of chemotherapy.
Conditions
Conditions (12)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Childhood Burkitt Lymphoma | Childhood Burkitt Lymphoma | ONTOLOGY_EXACT | 0.98 |
| Childhood Diffuse Large Cell Lymphoma | — | UNRESOLVED | — |
| Childhood Immunoblastic Large Cell Lymphoma | Childhood Immunoblastic Lymphoma | ALIAS | 0.90 |
| Stage I Childhood Large Cell Lymphoma | — | UNRESOLVED | — |
| Stage I Childhood Small Noncleaved Cell Lymphoma | — | UNRESOLVED | — |
| Stage II Childhood Large Cell Lymphoma | — | UNRESOLVED | — |
| Stage II Childhood Small Noncleaved Cell Lymphoma | — | UNRESOLVED | — |
| Stage III Childhood Large Cell Lymphoma |
Interventions
Interventions (14)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| cyclophosphamide | Drug | Cyclophosphamide | ALIAS |
| cytarabine | Drug | Cytarabine | ALIAS |
| doxorubicin hydrochloride | Drug | Doxorubicin | ALIAS |
| etoposide | Drug | Etoposide | ALIAS |
| filgrastim | Biological | Filgrastim | ALIAS |
| hydrocortisone sodium succinate | Drug | — | UNRESOLVED |
| laboratory biomarker analysis | Other | — | UNRESOLVED |
| leucovorin calcium | Drug | Leucovorin | ALIAS |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Group B (chemotherapy, protective therapy, monoclonal antib.)
- description
- Therapies given IV, IT, orally, or SC. Please see treatment outline. See Detailed Description.
- interventionNames
- Drug: doxorubicin hydrochloride
- Drug: cyclophosphamide
- Drug: methotrexate
- Drug: rasburicase
- Drug: leucovorin calcium
- Drug: prednisone
- Drug: methylprednisolone
- Biological: filgrastim
- Biological: rituximab
- Drug: cytarabine
- Drug: vincristine sulfate
- Drug: hydrocortisone sodium succinate
- Other: laboratory biomarker analysis
- type
- EXPERIMENTAL
- label
- Group C (Chemotherapy, monoclonal antibody therapy)
- description
- Therapies given IV, IT, orally, or subcutaneously (same as FAB B with the addition of etoposide and high-dose methotrexate). See Detailed Description.
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 1 Year
- Maximum age
- 29 Years
Show eligibility criteria text
Inclusion Criteria:
* Newly diagnosed mature B-lineage (CD20-positive) leukemia or lymphoma by the REAL classification of 1 of the following subtypes:
* Diffuse large cell lymphoma
* Burkitt's lymphoma
* High-grade B-cell lymphoma (Burkitt-like)
* No B-cell anaplastic large cell Ki-1 positive lymphomas and B-lymphoblastic lymphomas
* One of the following FAB prognostic groups:
* Group B (intermediate risk)
* Group C (high risk)
* Bone marrow involvement with at least 25% blasts and/or CNS involvement meeting 1 or more of the following criteria:
* Any L3 blasts in cerebrospinal fluid
* Cranial nerve palsy (if not explained by extracranial tumor)
* Clinical spinal cord compression
* Isolated intracerebral mass
* Parameningeal extension (cranial and/or spinal)
* Hepatitis B status known
* Not pregnant or nursing
* Negative pregnancy test
* Fertile patients must use effective contraception during and for 6 months after study participation
* No known history of congenital immune deficiency and/or laboratory evidence of acquired immune deficiency
* No known G6PD deficiency (if receiving rasburicase)
* No prior malignancies treated with systemic chemotherapy with alkylator or anthracycline therapy
* No prior chemotherapy
* At least 1 week since prior steroids except emergency steroids initiated within 72 hours of study entry
* No prior radiotherapy except emergency radiotherapy initiated within 72 hours of study entry
* No concurrent radiotherapy
* No prior solid organ transplantationReferences
Publications (2)
- BACKGROUNDShiramizu B, Goldman S, Kusao I, Agsalda M, Lynch J, Smith L, Harrison L, Morris E, Gross TG, Sanger W, Perkins S, Cairo MS. Minimal disease assessment in the treatment of children and adolescents with intermediate-risk (Stage III/IV) B-cell non-Hodgkin lymphoma: a children's oncology group report. Br J Haematol. 2011 Jun;153(6):758-63. doi: 10.1111/j.1365-2141.2011.08681.x. Epub 2011 Apr 18. PMID 21496005
- DERIVEDFrazer JK, Li KJ, Galardy PJ, Perkins SL, Auperin A, Anderson JR, Pinkerton R, Buxton A, Gross TG, Michon J, Leverger G, Weinstein HJ, Harrison L, Shiramizu B, Barth MJ, Goldman SC, Patte C, Cairo MS. Excellent outcomes in children and adolescents with CNS+ Burkitt lymphoma or other mature B-NHL using only intrathecal and systemic chemoimmunotherapy: results from FAB/LMB96 and COG ANHL01P1. Br J Haematol. 2019 Apr;185(2):374-377. doi: 10.1111/bjh.15520. Epub 2018 Aug 16. No abstract available. PMID 30117142