Phase II Trial of Low-Dose Methotrexate and Iodine I 131 Tositumomab for Previously Untreated, Advanced-Stage, Follicular Lymphoma
This is a single-arm, single institution, Phase II study to test the use of low-dose
methotrexate in combination with I-131 tositumomab for its ability to lower the rate of
(human anti-mouse antibody) HAMA formation in patients with previously untreated low-grade
follicular lymphoma. Low-dose methotrexate will be given beginning 3 weeks prior to the
first infusion of I-131 tositumomab (4 weekly doses) and continued for 6 weeks (10 total
doses), the period of time during which the development of HAMA is most detrimental. A total
of 61 patients will be enrolled. The primary endpoint of the study is the determination of
the rate of HAMA conversion within the first seven weeks following treatment. The secondary
endpoints include response rates, progression-free and overall survival, safety, and
evaluation of the effect of methotrexate on blood lymphocyte subsets.
Interventional
Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
determination of the rate of HAMA (human anti-mouse antibody) conversion following treatment
2 years
No
Daniel Lebovic, M.D.
Principal Investigator
University of Michigan
United States: Institutional Review Board
UMCC 2010.098
NCT01389076
July 2011
July 2017
Name | Location |
---|---|
University of Michigan | Ann Arbor, Michigan 48109-0624 |