Trial of Low-Dose Methotrexate and I 131 Tositumomab for Previously Untreated, Advanced-Stage, Follicular Lymphoma
Status:
Terminated
Trial end date:
2016-06-01
Target enrollment:
Participant gender:
Summary
Patients with a type of non-Hodgkin lymphoma, called follicular lymphoma and have not yet had
previous systemic treatment, such as chemotherapy or immunotherapy will be invited to
participate. This research study is being conducted in order to evaluate the combination of
lowdose methotrexate and Iodine I 131 tositumomab (Bexxar) with regards to whether the
combination will reduce the occurrence of the HAMA (Human Anti-Mouse Antibody) response. HAMA
is an immune reaction against the tositumomab protein. Symptoms arising from HAMA can range
from a mild form, like a rash, to a more extreme and possibly life-threatening level. HAMA
can also decrease the effectiveness of the treatment, or create a future reaction if a
patient is given another treatment containing mouse antibodies. In addition to evaluating the
occurrence of HAMA, this research study will also look at the short and long-term
effectiveness of this combination in the treatment of lymphoma, as well as its safety.
Phase:
Phase 2
Details
Lead Sponsor:
University of Michigan Cancer Center University of Michigan Rogel Cancer Center