A Phase II, Single-Arm Trial of Epratuzumab, an Anti-CD22 Humanized Antibody, in Patients With Waldenstrom's Macroglobulinemia
This multi-center, single-arm study of epratuzumab is in patients with Waldenström's
Macroglobulinemia (WM) who failed chemotherapy. After baseline evaluations, patients receive
epratuzumab infused over approximately 30-60 minutes at 360 mg/m2, administered once weekly
for 4 consecutive weeks (days 1, 8, 15, 22). Post-treatment evaluations occur on the day of
the last infusion, then at 6 and 12 weeks. Patients without progression of disease continue
long-term follow up until disease progression or for at least 5 years, with evaluations
every 3 months for 2 years, then semi-annually. Otherwise, follow-up is only required until
resolution of any treatment related abnormalities.
Allocation: Non-Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Serum measurements of IgM will be the primary determination of efficacy.
United States: Food and Drug Administration
|Weill Medical College of Cornell/ New York Presbyterian Hospital||New York, New York 10021|
|Columbia University College of Physicans & Surgeons||New York, New York 10032|