Phase II Study Of Iodine-131 Anti-B1 Antibody Plus CHOP For Patients With Previously Untreated Mantle Cell Lymphoma
The primary efficacy endpoint of this study is to determine the duration of response of the
sequential administration of Iodine-131 Anti-B1 Antibody followed by six cycles of CHOP for
patients with previously untreated MCL. The secondary efficacy endpoints for this study are
to determine the response rate, confirmed response rate, complete response rate, confirmed
complete response rate, duration of response for confirmed responders, duration of response
for complete responders, duration of response for confirmed complete responders,
progression-free survival, time to treatment failure, and the predictive value of detection
of minimal residual disease by molecular techniques on response duration. The
pharmacokinetic endpoint is to determine the total body residence time of Iodine-131 Anti-B1
Antibody following the dosimetric dose. The safety endpoints are to determine the incidence
of adverse experiences, hematologic toxicity, (e.g., nadir, time to nadir, and time to
recovery), use of supportive care, percent of patients converting to human anti-murine
antibody (HAMA) positivity, the effects of Iodine-131 Anti-B1 Antibody on the growth and
function of hematopoietic progenitor cells, and survival of patients with previously
untreated MCL treated with Iodine-131 Anti-B1 Antibody followed by six cycles of CHOP.
Interventional
Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
United States: Food and Drug Administration
CP-99-037
NCT00022945
Name | Location |
---|---|
Memorial Sloan-Kettering Cancer Center | New York, New York 10021 |
Rush-Presbyterian-St. Lukes Medical Center | Chicago, Illinois 60612 |
Hospital of the University of Pennsylvania | Philadelphia, Pennsylvania 19104 |