Pilot Trial of Hyper-CVAD and Methotrexate/ARA C Plus Rituximab in Patients With Previously Untreated Mantle Cell Lymphoma
OBJECTIVES:
- 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.
Interventional
Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Progression-free Survival
Progression-Free Survival (PFS) rate at 1 year. PFS measured from date of registration to date of first observation of progressive disease or death due to any cause. Progressive disease is a 50% increase in the sum of products of greatest diameters (SPD) of target measurable lesions over the smallest sum observed if a complete response (confirmed, or unconfirmed) was not previously achieved; appearance of a new lesion/site; unequivocal progression of non-measurable disease; or death due to disease without prior documentation of progression.
assessed after cycle 4, after completion of treatment, then every 3 months until 1 year after registration
No
Elliot M. Epner, MD, PhD
Study Chair
OHSU Knight Cancer Institute
United States: Federal Government
CDR0000069445
NCT00041132
September 2002
June 2011
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