Study of Epratuzumab (hLL2) in Patients With Waldenstrom's Macroglobulinemia

Waldenstrom Macroglobulinemia Clinical Trial

Official title:

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT00113802
• Other study ID #: IM-T-hLL2-18-US
• Status: Terminated
• Phase: Phase 2
• Start date: August 2004
• Est. completion date: December 2006

Study information

• Verified date: February 2008
• Source: Gilead Sciences
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The purpose of this study is to determine whether epratuzumab provides effective therapy in Waldenström's Macroglobulinemia (WM).

Description:

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 31
• Est. completion date: December 2006
• Est. primary completion date: December 2006
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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)

Related Conditions & MeSH terms

• Waldenstrom Macroglobulinemia

Intervention

Drug:
• Epratuzumab (hLL2- anti-CD22 humanized antibody)

Locations

Country	Name	City	State
United States	Columbia University College of Physicans & Surgeons	New York	New York
United States	Weill Medical College of Cornell/ New York Presbyterian Hospital	New York	New York

Sponsors (1)

Lead Sponsor	Collaborator
Gilead Sciences

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Serum measurements of IgM will be the primary determination of efficacy.