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

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

Status

Terminated

Phases

Phase 2

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00113802

Enrollment

Registered

2005-06-13

Start date

2004-08-31

Completion date

2006-12-31

Last updated

2021-08-19

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Waldenstrom Macroglobulinemia

Keywords

Epratuzumab (hLL2- anti-CD22 humanized antibody), Waldenstrom's Macroglobulinemia, Waldenstrom Macroglobulinemia, Hematologic Disease, Hematologic Diseases, Paraproteinemias, Vascular Hemostatic Disorders, Lymphoproliferative Disorders

Brief summary

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

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.

Interventions

DRUGEpratuzumab (hLL2- anti-CD22 humanized antibody)

Study design

Allocation

NON_RANDOMIZED

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

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)

Design outcomes

Primary

Measure	Time frame
Serum measurements of IgM will be the primary determination of efficacy.	—

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026