NCT00113802

Brief Summary

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

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
31

participants targeted

Target at P25-P50 for phase_2

Timeline
Completed

Started Aug 2004

Geographic Reach
1 country

2 active sites

Status
terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 1, 2004

Completed
10 months until next milestone

First Submitted

Initial submission to the registry

June 10, 2005

Completed
3 days until next milestone

First Posted

Study publicly available on registry

June 13, 2005

Completed
1.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2006

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2006

Completed
Last Updated

August 19, 2021

Status Verified

February 1, 2008

Enrollment Period

2.3 years

First QC Date

June 10, 2005

Last Update Submit

August 12, 2021

Conditions

Waldenstrom Macroglobulinemia

Keywords

Epratuzumab (hLL2- anti-CD22 humanized antibody)Waldenstrom's MacroglobulinemiaWaldenstrom MacroglobulinemiaHematologic DiseaseHematologic DiseasesParaproteinemiasVascular Hemostatic DisordersLymphoproliferative Disorders

Outcome Measures

Primary Outcomes (1)

  • Serum measurements of IgM will be the primary determination of efficacy.

Interventions

Epratuzumab (hLL2- anti-CD22 humanized antibody)DRUG

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Weill Medical College of Cornell/ New York Presbyterian Hospital

New York, New York, 10021, United States

Location

Columbia University College of Physicans & Surgeons

New York, New York, 10032, United States

Location

MeSH Terms

Conditions

Waldenstrom MacroglobulinemiaHematologic DiseasesParaproteinemiasHemostatic DisordersLymphoproliferative Disorders

Interventions

epratuzumab

Condition Hierarchy (Ancestors)

Neoplasms, Plasma CellNeoplasms by Histologic TypeNeoplasmsVascular DiseasesCardiovascular DiseasesBlood Protein DisordersHemic and Lymphatic DiseasesHemorrhagic DisordersLymphatic DiseasesImmunoproliferative DisordersImmune System Diseases

Study Design

Study Type
interventional
Phase
phase 2
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY

Study Record Dates

First Submitted

June 10, 2005

First Posted

June 13, 2005

Study Start

August 1, 2004

Primary Completion

December 1, 2006

Study Completion

December 1, 2006

Last Updated

August 19, 2021

Record last verified: 2008-02

Locations

US(2)