S0213 Chemotherapy Plus Rituximab in Treating Patients With Mantle Cell Lymphoma
NCT ID: NCT00041132
Last Updated: 2012-11-01
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE2
56 participants
INTERVENTIONAL
2002-09-30
2011-06-30
Brief Summary
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PURPOSE: Phase II pilot study to study the effectiveness of combining chemotherapy with rituximab in treating patients who have newly diagnosed mantle cell lymphoma.
Detailed Description
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* Determine the 1-year progression-free survival probability in patients with previously untreated mantle cell lymphoma treated with courses of rituximab and cyclophosphamide, doxorubicin, vincristine, and dexamethasone alternating with courses of rituximab and high-dose cytarabine and methotrexate with leucovorin calcium.
* Determine the response rate (complete unconfirmed and complete and partial responses) and survival of patients treated with this regimen.
* Determine the toxicity of this regimen in these patients.
* Correlate chromosomal breakpoints, translocated immunoglobulin regulatory sequences, and cyclins D1, D2, and D3 with response and progression-free survival in patients treated with this regimen.
* Correlate gene expression (measured by DNA microarray analysis) with response and progression-free survival in patients treated with this regimen.
OUTLINE: This is a pilot, multicenter study.
* Courses 1, 3, 5, and 7: Patients receive rituximab IV on day 1 (courses 1, 3, and 5 only); cyclophosphamide IV over 3 hours twice a day on days 2-4; doxorubicin IV over 24 hours on days 5-7; vincristine IV on days 5 and 12; dexamethasone orally or IV four times a day on days 2-5 and 12-15; and filgrastim (G-CSF) subcutaneously (SC) daily beginning on day 8 and continuing until blood counts recover.
* Courses 2, 4, 6, and 8: Patients receive rituximab IV on day 1 (courses 2, 4, and 6 only); high-dose methotrexate IV over 24 hours on day 2; high-dose cytarabine IV over 2 hours twice a day on days 3-4; oral leucovorin calcium 4 times a day on days 3-10; and G-CSF SC daily beginning on day 5 and continuing until blood counts recover.
Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.
Patients are followed within 30 days, every 3 months for 2 years, and then every 6 months for 3 years. Patients with disease progression are followed annually for up to 5 years from study entry.
PROJECTED ACCRUAL: Approximately 50 patients will be accrued for this study within 25 months.
Conditions
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Keywords
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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Hyper-CVAD + MTX/Ara-C + Rituximab
21-day cycles of Hyper-CVAD and high-dose methotrexate/cytarabine are alternated beginning with Hyper-CVAD for a maximum of 8 cycles. Rituximab is given for cycles 1-6.
Hyper-CVAD (cycles 1,3,5,7): rituximab 375 mg/m\^2 on day 1, mesna 600 mg/m\^2 on days 2-4, cyclophosphamide 300 mg/m\^2 on days 2-4, doxorubicin 16.6 mg/m\^2/day on days 5-7, vincristine 1.4 mg/m\^2 on days 5 and 12, dexamethasone 40 mg on days 2-5 and 12-15, and filgrastim 5 ug/kg on days 8-21.
Methotrexate/Ara-C (cycles 2,4,6,8): rituximab 375 mg/m\^2 on day 1, methotrexate 1000 mg/m\^2 over days 2-3, Ara-C 12 g/m\^2 over days 3-4, leucovorin 170 mg over days 3-5, and G-CSF 5 ug/kg on days 5-21.
filgrastim
5 ug/kg
rituximab
375 mg/m\^2 on day 1 of cycles 1-6
cyclophosphamide
300 mg/m\^2 on days 2-4 of cycles 1,3,5,7
cytarabine
12 g/m\^2 over days 3-4 of cycles 2,4,6,8
dexamethasone
40 mg on days 2-5 and 12-15 of cycles 1,3,5,7
doxorubicin
16.6 mg/m\^2/day for days 5-7 of cycles 1,3,5,7
leucovorin
170 mg over days 3-5 of cycles 2,4,6,8
methotrexate
1000 mg/m\^2 over days 2-3 of cycles 2,4,6,8
vincristine
1.4 mg/m\^2 on days 5 and 12 of cycles 1,3,5,7
Interventions
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filgrastim
5 ug/kg
rituximab
375 mg/m\^2 on day 1 of cycles 1-6
cyclophosphamide
300 mg/m\^2 on days 2-4 of cycles 1,3,5,7
cytarabine
12 g/m\^2 over days 3-4 of cycles 2,4,6,8
dexamethasone
40 mg on days 2-5 and 12-15 of cycles 1,3,5,7
doxorubicin
16.6 mg/m\^2/day for days 5-7 of cycles 1,3,5,7
leucovorin
170 mg over days 3-5 of cycles 2,4,6,8
methotrexate
1000 mg/m\^2 over days 2-3 of cycles 2,4,6,8
vincristine
1.4 mg/m\^2 on days 5 and 12 of cycles 1,3,5,7
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Histologically proven stage III/IV or bulky stage II mantle cell lymphoma of one of the following histologic subtypes:
* Nodular
* Diffuse
* Mantle zone
* Blastic
* Newly diagnosed and previously untreated disease
* Bidimensionally measurable disease
PATIENT CHARACTERISTICS:
Age:
* 18 to 69
Performance status:
* Zubrod 0-2
Life expectancy:
* Not specified
Hematopoietic:
* Absolute neutrophil count at least 1,000/mm\^3
* Platelet count at least 100,000/mm\^3 (50,000/mm\^3 if marrow involvement present)
Hepatic:
* Bilirubin no greater than 1.5 mg/dL (5.0 mg/dL if hepatic involvement present)
Renal:
* Creatinine no greater than 2.0 mg/dL
* Creatinine clearance greater than 50 mL/min
Cardiovascular:
* Ejection fraction at least 50% by MUGA or 2-D echocardiogram
* No significant abnormalities by EKG
Other:
* Not pregnant or nursing
* Fertile patients must use effective contraception
* Willing to receive blood product transfusions
* No known sensitivity to E. coli-derived proteins
* No known AIDS syndrome or HIV-associated complex
* No other malignancy within the past 5 years except adequately treated basal cell or squamous cell skin cancer or carcinoma in situ of the cervix
PRIOR CONCURRENT THERAPY:
Biologic therapy:
* No prior monoclonal antibody therapy
Chemotherapy:
* No prior chemotherapy for lymphoma
Endocrine therapy:
* Not specified
Radiotherapy:
* No prior radiotherapy for lymphoma
Surgery:
* Not specified
18 Years
69 Years
ALL
No
Sponsors
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National Cancer Institute (NCI)
NIH
SWOG Cancer Research Network
NETWORK
Responsible Party
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Principal Investigators
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Elliot M. Epner, MD, PhD
Role: STUDY_CHAIR
OHSU Knight Cancer Institute
Countries
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References
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A multi center trial of hyperCVAD+rituxan in patients with newly diagnosed mantle cell lymphoma EM Epner; J Unger; T Miller; L Rimsza; C Spier; M LeBlanc; R Fisher. Blood 110(11):#387. (2007).
Other Identifiers
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S0213
Identifier Type: OTHER
Identifier Source: secondary_id
CDR0000069445
Identifier Type: -
Identifier Source: org_study_id