Phase II Trial of Rituximab and 2-Chlorodeoxyadenosine (2-CDA) in Newly Diagnosed Mantle Cell Lymphoma (MCL)
OBJECTIVES:
- Determine whether rituximab and cladribine will increase the complete remission rate
and the unconfirmed complete remission rate in patients with mantle cell lymphoma.
- Determine the time to progression in patients treated with this regimen.
- Determine the toxic effects of this regimen in these patients.
OUTLINE: This is a multicenter study.
An initial cohort of 6 patients at Mayo Clinic receives rituximab IV over 4-8 hours on day 1
and cladribine IV over 2 hours on days 4-8. If 2 or more patients experience unacceptable
toxicity during the first course, the study is discontinued; otherwise, the study is opened
for enrollment at all NCCTG sites. (The phase II study is open for enrollment as of
5/14/04.)
Treatment repeats every 28 days for a total of 2-6 courses in the absence of disease
progression or unacceptable toxicity.
Patients are followed every 2 months for 1 year, every 4 months for 1 year, every 6 months
for 1 year, and then annually for 2 years.
PROJECTED ACCRUAL: A total of 31 patients will be accrued for this study within 21 months.
Interventional
Masking: Open Label, Primary Purpose: Treatment
Complete remission (CR) and complete remission unconfirmed (CRu) rate at the close of study therapy assessment (after 2, 4, or 6 courses)
No
David J. Inwards, MD
Study Chair
Mayo Clinic
United States: Federal Government
CDR0000269055
NCT00053027
February 2003
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