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A Phase II, Single-Arm Trial of Epratuzumab, an Anti-CD22 Humanized Antibody, in Patients With Waldenstrom's Macroglobulinemia


Phase 2
18 Years
N/A
Not Enrolling
Both
Waldenstrom Macroglobulinemia

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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