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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:
National Cancer Institute (NCI)
Information provided by (Responsible Party):
Children's Oncology Group
ClinicalTrials.gov Identifier:
NCT00057811
First received: April 7, 2003
Last updated: September 10, 2014
Last verified: September 2014
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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 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:
Rasburicase
Genetic and Rare Diseases Information Center resources:
Lymphosarcoma
Acute Lymphoblastic Leukemia
Chronic Lymphocytic Leukemia
Leukemia, B-cell, Chronic
Childhood Acute Lymphoblastic Leukemia
Diffuse Large B-Cell Lymphoma
Lymphoma, Large-cell
Burkitt Lymphoma
Plasmablastic Lymphoma
Lymphoma, Large-cell, Immunoblastic
B-cell Lymphoma
U.S. FDA Resources
Further study details as provided by Children's Oncology Group:
Primary Outcome Measures:
- Grade ≥ 3 Stomatitis [ Time Frame: Up to 1 year ]The incidence of grade ≥ 3 stomatitis. Grade 3 stomatitis: Confluent ulcerations or pseudomembranes; bleeding with minor trauma. Grade 4 stomatitis: Tissue necrosis; Significant spontaneous bleeding; life-threatening consequences
- Response Rate [ Time Frame: Up to 5 years ]Response includes both complete and partial responses. Per protocol, complete Response is defined as the complete disappearance of all clinical evidence of disease by physical examination, by imaging studies, by bone marrow biopsy (where indicated), by CNS evaluation (where indicated) and by biopsy where there is a residual abnormality on an imaging study. Bone marrow must contain <5% blasts. CSF WBC must be <5/μL with no blasts or lymphomatous cells present. Partial response is defined as: at least a 50% reduction in the size of all measurable tumor areas. Each site is to be defined by the product of the maximum length, width and depth (3 dimensions). No lesion may progress. No new lesion may appear. Bone marrow must contain <5% blasts. CSF WBC must be <5/μL with no blasts or lymphomatous cells present..
- Minimal Residual Disease [ Time Frame: Not Provided ]The presence or absence of tumor cells at the end of induction assessed by studying tissue and/or blood/marrow. Details of methods and criteria used can be found in Shiramizu at al. BJH 153:758-763, 2011 (full citation in the citation section).
- Toxic Death [ Time Frame: Up to 1 year ]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.
| Enrollment: | 97 |
| Study Start Date: | June 2004 |
| Study Completion Date: | July 2014 |
| 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 (Child, Adult) |
| Sexes Eligible for Study: | All |
| 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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study.
To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below.
For general information, see Learn About Clinical Studies.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00057811
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
National Cancer Institute (NCI)
Investigators
| Principal Investigator: | Mitchell Cairo, MD CCRP | Children's Oncology Group |
More Information
Publications:
| Responsible Party: | Children's Oncology Group |
| ClinicalTrials.gov Identifier: | NCT00057811 History of Changes |
| Other Study ID Numbers: |
ANHL01P1 NCI-2009-00405 ( Registry Identifier: CTRP (Clinical Trial Reporting Program) ) COG-ANHL01P1 ( Other Identifier: Children's Oncology Group ) CDR0000271941 ( Other Identifier: Clinical Trials.gov ) U10CA098543 ( US NIH Grant/Contract Award Number ) |
| Study First Received: | April 7, 2003 |
| Results First Received: | January 21, 2014 |
| Last Updated: | September 10, 2014 |
Additional relevant MeSH terms:
|
Lymphoma Leukemia Lymphoma, Non-Hodgkin Precursor Cell Lymphoblastic Leukemia-Lymphoma Leukemia, Lymphoid Lymphoma, Large B-Cell, Diffuse Burkitt Lymphoma Lymphoma, Large-Cell, Immunoblastic Plasmablastic Lymphoma Leukemia, B-Cell Leukemia, Lymphocytic, Chronic, B-Cell Neoplasms by Histologic Type Neoplasms Lymphoproliferative Disorders Lymphatic Diseases |
Immunoproliferative Disorders Immune System Diseases Lymphoma, B-Cell Epstein-Barr Virus Infections Herpesviridae Infections DNA Virus Infections Virus Diseases Tumor Virus Infections Cyclophosphamide Methotrexate Cytarabine Rasburicase Rituximab Etoposide phosphate Liposomal doxorubicin |
ClinicalTrials.gov processed this record on June 22, 2017