NCT00142155

Brief Summary

The purpose of this study is to determine if the type of Fc gamma RIIIa receptor that a particular patient's immune cells possess influences how they respond to rituximab and other monoclonal antibodies.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
300

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Jan 2002

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

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

January 1, 2002

Completed
3.7 years until next milestone

First Submitted

Initial submission to the registry

September 1, 2005

Completed
1 day until next milestone

First Posted

Study publicly available on registry

September 2, 2005

Completed
1.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2007

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2007

Completed
Last Updated

June 27, 2011

Status Verified

June 1, 2011

Enrollment Period

5.2 years

First QC Date

September 1, 2005

Last Update Submit

June 23, 2011

Conditions

Waldenstrom's Macroglobulinemia

Keywords

monoclonal antibodyFc gamma RIII receptor expressionrituximab

Interventions

RituximabDRUG
monoclonal antibodiesDRUG

Eligibility Criteria

Age30 Years - 90 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Patients treated with rituximab or other monoclonal antibodies for Waldenstrom's macroglobulinemia

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Dana-Farber Cancer Institute

Boston, Massachusetts, 02115, United States

Location

MeSH Terms

Conditions

Waldenstrom Macroglobulinemia

Interventions

RituximabAntibodies, Monoclonal

Condition Hierarchy (Ancestors)

Neoplasms, Plasma CellNeoplasms by Histologic TypeNeoplasmsHemostatic DisordersVascular DiseasesCardiovascular DiseasesParaproteinemiasBlood Protein DisordersHematologic DiseasesHemic and Lymphatic DiseasesHemorrhagic DisordersLymphoproliferative DisordersLymphatic DiseasesImmunoproliferative DisordersImmune System Diseases

Intervention Hierarchy (Ancestors)

Antibodies, Monoclonal, Murine-DerivedAntibodiesImmunoglobulinsImmunoproteinsBlood ProteinsProteinsAmino Acids, Peptides, and ProteinsSerum GlobulinsGlobulins

Study Officials

  • Steven Treon, MD, MA, PhD

    Dana-Farber Cancer Institute

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Sponsor Type
OTHER

Study Record Dates

First Submitted

September 1, 2005

First Posted

September 2, 2005

Study Start

January 1, 2002

Primary Completion

March 1, 2007

Study Completion

March 1, 2007

Last Updated

June 27, 2011

Record last verified: 2011-06

Locations

US(1)