Lymphoma Clinical Trial
Official title:
A Phase II, Open-Label, Randomized, Multicenter Trial To Evaluate The Preliminary Safety And Efficacy of Hu1D10 In Patients With Relapsed Or Refractory Grades I, II, or III B-Cell Non-Hodgkin's Lymphoma (Including Follicular, Small Lymphocytic And Marginal Zone/MALT)
RATIONALE: Monoclonal antibodies can locate cancer cells and either kill them or deliver
cancer-killing substances to them without harming normal cells.
PURPOSE: Randomized phase II trial to compare the effectiveness of two different monoclonal
antibody regimens in treating patients who have relapsed or refractory non-Hodgkin's
lymphoma.
OBJECTIVES:
- Compare the relative safety of 3 different regimens of monoclonal antibody Hu1D10 in
patients with relapsed or refractory grade I, II, or III B-cell non-Hodgkin's lymphoma.
- Compare the preliminary tumor response and progression-free survival of patients
treated with these regimens.
OUTLINE: This is a randomized, multicenter study. Patients are randomized to 1 of 3
treatment arms.
- Arm I: Patients receive monoclonal antibody (MOAB) Hu1D10 IV over approximately 2 hours
on days 1, 8, 15, and 22.
- Arm II: Patients receive MOAB Hu1D10 as in arm I at a higher dose.
- Arm III:Patients receive MOAB Hu1D10 IV on days 1, 3, 5, 8, 10, 12, 15, 17, 19, 22, 24,
and 26.
Treatment in all arms continues in the absence of disease progression or unacceptable
toxicity.
Patients are followed at weeks 1, 4, and 12 and then at months 6, 9, 12, 18, and 24.
PROJECTED ACCRUAL: A total of 60 patients will be accrued for this study.
;
Allocation: Randomized, Primary Purpose: Treatment
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