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Correlation of FC Gamma RIIIA Receptor Response in Patients With Waldenstrom's Macroglobulinemia

Primary Purpose

Waldenstrom's Macroglobulinemia

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Rituximab
monoclonal antibodies
Sponsored by
Dana-Farber Cancer Institute
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional trial for Waldenstrom's Macroglobulinemia focused on measuring monoclonal antibody, Fc gamma RIII receptor expression, rituximab

Eligibility Criteria

30 Years - 90 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria: Patients treated with rituximab or other monoclonal antibodies for Waldenstrom's macroglobulinemia

Sites / Locations

  • Dana-Farber Cancer Institute

Outcomes

Primary Outcome Measures

Secondary Outcome Measures

Full Information

First Posted
September 1, 2005
Last Updated
June 23, 2011
Sponsor
Dana-Farber Cancer Institute
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1. Study Identification

Unique Protocol Identification Number
NCT00142155
Brief Title
Correlation of FC Gamma RIIIA Receptor Response in Patients With Waldenstrom's Macroglobulinemia
Official Title
Correlation of Fc Gamma RIIIA Receptor Expression and Response to Rituximab and Other Monoclonal Antibodies in Patients With Waldenstrom's Macroglobulinemia
Study Type
Interventional

2. Study Status

Record Verification Date
June 2011
Overall Recruitment Status
Completed
Study Start Date
January 2002 (undefined)
Primary Completion Date
March 2007 (Actual)
Study Completion Date
March 2007 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
Dana-Farber Cancer Institute

4. Oversight

5. Study Description

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.
Detailed Description
A medical data collection survey sheet will be filled out by the patient or doctor with medical information pertaining to how the patient responded to rituximab and other monoclonal antibodies for use in this study. Blood work will be performed to analyze the blood by molecular technology to find the kind of Fc gamna RIIIa receptor the patient possess and correlate these findings with the outcome of treatment with rituximab or other monoclonal antibodies.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Waldenstrom's Macroglobulinemia
Keywords
monoclonal antibody, Fc gamma RIII receptor expression, rituximab

7. Study Design

Study Phase
Not Applicable
Enrollment
300 (Anticipated)

8. Arms, Groups, and Interventions

Intervention Type
Drug
Intervention Name(s)
Rituximab
Intervention Type
Drug
Intervention Name(s)
monoclonal antibodies

10. Eligibility

Sex
All
Minimum Age & Unit of Time
30 Years
Maximum Age & Unit of Time
90 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Patients treated with rituximab or other monoclonal antibodies for Waldenstrom's macroglobulinemia
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Steven Treon, MD, MA, PhD
Organizational Affiliation
Dana-Farber Cancer Institute
Official's Role
Principal Investigator
Facility Information:
Facility Name
Dana-Farber Cancer Institute
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02115
Country
United States

12. IPD Sharing Statement

Learn more about this trial

Correlation of FC Gamma RIIIA Receptor Response in Patients With Waldenstrom's Macroglobulinemia

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