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)
- 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
- 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,
Treatment in all arms continues in the absence of disease progression or unacceptable
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
Tillman Pearce, MD
United States: Federal Government
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