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

Sponsor
Gilead Sciences (Industry)
Overall Status
Terminated
CT.gov ID
NCT00113802
Collaborator
(none)
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Study Details

Study Description

Brief Summary

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

Condition or Disease Intervention/Treatment Phase
  • Drug: Epratuzumab (hLL2- anti-CD22 humanized antibody)
Phase 2

Detailed 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.

Study Design

Study Type:
Interventional
Allocation:
Non-Randomized
Intervention Model:
Single Group Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
A Phase II, Single-Arm Trial of Epratuzumab, an Anti-CD22 Humanized Antibody, in Patients With Waldenstrom's Macroglobulinemia
Study Start Date :
Aug 1, 2004
Actual Primary Completion Date :
Dec 1, 2006
Actual Study Completion Date :
Dec 1, 2006

Outcome Measures

Primary Outcome Measures

  1. Serum measurements of IgM will be the primary determination of efficacy. []

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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)

Contacts and Locations

Locations

Site City State Country Postal Code
1 Weill Medical College of Cornell/ New York Presbyterian Hospital New York New York United States 10021
2 Columbia University College of Physicans & Surgeons New York New York United States 10032

Sponsors and Collaborators

  • Gilead Sciences

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
, ,
ClinicalTrials.gov Identifier:
NCT00113802
Other Study ID Numbers:
  • IM-T-hLL2-18-US
First Posted:
Jun 13, 2005
Last Update Posted:
Aug 19, 2021
Last Verified:
Feb 1, 2008

Study Results

No Results Posted as of Aug 19, 2021