A Phase II, Single-Arm Trial of Epratuzumab, an Anti-CD22 Humanized Antibody, in Patients With Waldenstrom's Macroglobulinemia
18 Years
N/A
Both
Waldenstrom Macroglobulinemia
Trial Information
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.
Inclusion Criteria:
- Documented diagnosis of Waldenström's Macroglobulinemia using criteria proposed at
2nd International Workshop on WM, Athens, Greece, 2002.
- Measurable disease, defined as serum monoclonal IgM protein ≥1000 mg/dL by
electrophoresis.
- Lymphoplasmacytic infiltration of the bone marrow >10% involvement.
- Failed at least one, but no more than 3, regimen(s) of prior therapy.
(Please consult with study site for full eligibility criteria)
Type of Study:
Interventional
Study Design:
Allocation: Non-Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Outcome Measure:
Serum measurements of IgM will be the primary determination of efficacy.
Authority:
United States: Food and Drug Administration
Study ID:
IM-T-hLL2-18-US
NCT ID:
NCT00113802
Start Date:
August 2004
Completion Date:
December 2006
Related Keywords:
- Waldenström Macroglobulinemia
- Epratuzumab (hLL2- anti-CD22 humanized antibody)
- Waldenstrom's Macroglobulinemia
- Waldenstrom Macroglobulinemia
- Hematologic Disease
- Hematologic Diseases
- Paraproteinemias
- Vascular Hemostatic Disorders
- Lymphoproliferative Disorders
- Waldenstrom Macroglobulinemia
Name | Location |
|---|---|
| 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 |
