Rituximab, Rasburicase, and Combination Chemotherapy in Treating Young Patients With Newly Diagnosed Advanced B-Cell Leukemia or Lymphoma
This study has been completed.
Sponsor:
Children's Oncology Group
Collaborator:
Information provided by (Responsible Party):
Children's Oncology Group
ClinicalTrials.gov Identifier:
NCT00057811
First received: April 7, 2003
Last updated: June 11, 2013
Last verified: June 2013
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Purpose
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.
| Condition | Intervention | Phase |
|---|---|---|
|
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 |
Drug: doxorubicin hydrochloride Drug: cyclophosphamide Drug: methotrexate Drug: rasburicase Drug: leucovorin calcium Drug: prednisone Drug: methylprednisolone Biological: filgrastim Biological: rituximab Drug: cytarabine Drug: etoposide Drug: vincristine sulfate Drug: hydrocortisone sodium succinate Other: laboratory biomarker analysis |
Phase 2 |
| Study Type: | Interventional |
| Study Design: | Allocation: Non-Randomized Endpoint Classification: Safety Study Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Treatment |
| Official Title: | 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 |
Resource links provided by NLM:
Drug Information available for:
Hydrocortisone acetate
Cyclophosphamide
Hydrocortisone
Prednisolone
Prednisolone acetate
Prednisone
Methylprednisolone acetate
Methotrexate
Methylprednisolone
Succinic acid
Prednisolone sodium phosphate
Hydrocortisone sodium succinate
Cytarabine
Prednisolone phosphate
Hydrocortisone cypionate
Leucovorin calcium
Prednisolone sodium succinate
Vincristine sulfate
Methylprednisolone sodium succinate
Hydrocortisone butyrate
Sodium succinate
Sulfate ion
Methotrexate sodium
Doxorubicin
Doxorubicin hydrochloride
Etoposide
Hydrocortisone valerate
Levoleucovorin
Hydrocortisone probutate
Etoposide phosphate
Filgrastim
Rasburicase
Lenograstim
Granulocyte colony-stimulating factor
Rituximab
U.S. FDA Resources
Further study details as provided by Children's Oncology Group:
Primary Outcome Measures:
- Toxicity rate of rituximab using the National Cancer Institute Common Terminology Criteria for Adverse Events (CTCAE) v. 3.0 [ Time Frame: Up to 1 year ] [ Designated as safety issue: Yes ]Two events are of particular interest, the incidence of grade ≥ 3 stomatitis and any occurrence of a toxic death. For the implementation of the toxic death rate stopping rule, a death must be possibly, probably or definitely attributable to rituximab and/or chemotherapy to be considered a toxic death.
- Response rate [ Time Frame: Up to 5 years ] [ Designated as safety issue: No ]Confidence intervals will be constructed for the proportion of patients who achieve at least a partial response prior to beginning consolidation. No correction for multiple comparisons will be made in these computations.
- Minimal residual disease [ Time Frame: Not Provided ] [ Designated as safety issue: No ]
| Enrollment: | 97 |
| Study Start Date: | June 2004 |
| Primary Completion Date: | October 2009 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Experimental: Group B (chemotherapy, protective therapy, monoclonal antib.)
Therapies given IV, IT, orally, or SC. Please see treatment outline. See Detailed Description.
|
Drug: doxorubicin hydrochloride
Given IV, IT, or orally
Other Names:
Drug: cyclophosphamide
Given IV
Other Names:
Drug: methotrexate
Given IV or IT
Other Names:
Drug: rasburicase
Given IV
Other Names:
Drug: leucovorin calcium
Given IV or orally
Other Names:
Drug: prednisone
Given IV or orally
Other Names:
Drug: methylprednisolone
Given IV or orally
Other Names:
Biological: filgrastim
Given subcutaneously
Other Names:
Biological: rituximab
Given IV
Other Names:
Drug: cytarabine
Given IT
Other Names:
Drug: vincristine sulfate
Given IV
Other Names:
Drug: hydrocortisone sodium succinate
Given IT
Other Names:
Other: laboratory biomarker analysis
Correlative studies
|
|
Experimental: Group C (Chemotherapy, monoclonal antibody therapy))
Therapies given IV, IT, orally, or subcutaneously (same as FAB B with the addition of etoposide and high-dose methotrexate). See Detailed Description.
|
Drug: doxorubicin hydrochloride
Given IV, IT, or orally
Other Names:
Drug: cyclophosphamide
Given IV
Other Names:
Drug: methotrexate
Given IV or IT
Other Names:
Drug: leucovorin calcium
Given IV or orally
Other Names:
Drug: prednisone
Given IV or orally
Other Names:
Drug: methylprednisolone
Given IV or orally
Other Names:
Biological: filgrastim
Given subcutaneously
Other Names:
Biological: rituximab
Given IV
Other Names:
Drug: cytarabine
Given IT
Other Names:
Drug: etoposide
Given IV
Other Names:
Drug: vincristine sulfate
Given IV
Other Names:
Drug: hydrocortisone sodium succinate
Given IT
Other Names:
Other: laboratory biomarker analysis
Correlative studies
|
Show Detailed Description Eligibility| Ages Eligible for Study: | 1 Year to 29 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Criteria
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 transplantation
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00057811
Locations
| United States, California | |
| Children's Oncology Group | |
| Arcadia, California, United States, 91006-3776 | |
Sponsors and Collaborators
Children's Oncology Group
Investigators
| Principal Investigator: | Mitchell Cairo | Children's Oncology Group |
More Information
No publications provided
| Responsible Party: | Children's Oncology Group |
| ClinicalTrials.gov Identifier: | NCT00057811 History of Changes |
| Other Study ID Numbers: | ANHL01P1, NCI-2009-00405, COG-ANHL01P1, CDR0000271941, U10CA098543 |
| Study First Received: | April 7, 2003 |
| Last Updated: | June 11, 2013 |
| Health Authority: | United States: Food and Drug Administration |
Additional relevant MeSH terms:
|
Burkitt Lymphoma Leukemia Leukemia, Lymphocytic, Chronic, B-Cell Leukemia, B-Cell Leukemia, Lymphoid Precursor Cell Lymphoblastic Leukemia-Lymphoma Lymphoma Lymphoma, Large B-Cell, Diffuse Lymphoma, Non-Hodgkin Lymphoma, Large-Cell, Immunoblastic Epstein-Barr Virus Infections Herpesviridae Infections DNA Virus Infections Virus Diseases Tumor Virus Infections |
Neoplasms by Histologic Type Neoplasms Lymphoma, B-Cell Neoplasms, Experimental Lymphoproliferative Disorders Lymphatic Diseases Immunoproliferative Disorders Immune System Diseases Antibodies Antibodies, Monoclonal Cyclophosphamide Cytarabine Methotrexate Lenograstim Rituximab |
ClinicalTrials.gov processed this record on June 13, 2013