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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

TERMINATED

Clinical Phase

PHASE2

Total Enrollment

31 participants

Study Classification

INTERVENTIONAL

Study Start Date

2004-08-31

Study Completion Date

2006-12-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

A Study of Belimumab in Treating Symptomatic Waldenstroms Macroglobulinaemia

NCT01142011

Symptomatic Waldenstroms Macroglobulinaemia

UNKNOWN PHASE2

Neihulizumab (ALTB-168) in Patients With Steroid-refractory Acute Graft-versus-host Disease or Treatment-refractory Acute Graft-versus-host Disease

NCT03327857

Steroid-refractory Acute Graft-versus-Host Disease Treatment-refractory Acute Graft-versus-Host Disease

COMPLETED PHASE1

Study of Ezatiostat (Telintra Tablets) for Treatment of Severe Chronic Neutropenia

NCT00909584

Severe Chronic Neutropenia

TERMINATED PHASE2

Reslizumab in the Treatment of Eosinophilic Granulomatosis With Polyangiitis (EGPA) Study

NCT02947945

Asthma

UNKNOWN PHASE2

Infliximab and Intravenous Immunoglobulin Therapy in Treating Patients With Steroid-Refractory Pneumonitis

NCT04438382

Hematopoietic and Lymphoid Cell Neoplasm Malignant Solid Neoplasm Steroid-Refractory Pneumonitis

TERMINATED PHASE2

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Waldenstrom Macroglobulinemia

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

NON_RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Epratuzumab (hLL2- anti-CD22 humanized antibody)

Intervention Type DRUG

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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)

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No