Correlation of FC Gamma RIIIA Receptor Response in Patien... | NCT00142155

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

NCT00142155

Sponsor

Dana-Farber Cancer Institute

Status

Completed

Last Update Posted

Jun 27, 2011Estimated

Enrollment

300Estimated

Phase

Not Applicable

Conditions

Waldenstrom's Macroglobulinemia

Interventions

Rituximab
monoclonal antibodies

Countries

United States

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Jun 2011

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jan 2002

Primary Completion Date

Mar 2007Actual

Completion Date

Mar 2007Actual

First Submitted Date

Sep 1, 2005

First Submission Date that Met QC Criteria

Sep 1, 2005

First Posted Date

Sep 2, 2005Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jun 23, 2011

Last Update Posted Date

Jun 27, 2011Estimated

Description Module

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.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

No data available

No data is available for this block.

Biospecimen

No data available

No data is available for this block.

Enrollment

300Estimated

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

30 Years

Maximum Age

90 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Steven Treon, MD, MA, PhD	Dana-Farber Cancer Institute	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Dana-Farber Cancer Institute		Boston	Massachusetts	02115	United States

Condition Browse Module

MeSH Terms

ID	Term
D008258	Waldenstrom Macroglobulinemia

Ancestor Terms

ID	Term
D054219	Neoplasms, Plasma Cell
D009370	Neoplasms by Histologic Type
D009369	Neoplasms
D020141	Hemostatic Disorders

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
D000069283	Rituximab
D000911	Antibodies, Monoclonal

Ancestor Terms

ID	Term
D058846	Antibodies, Monoclonal, Murine-Derived
D000906	Antibodies
D007136	Immunoglobulins
D007162	Immunoproteins

Browse Leaves

Not provided

Browse Branches

Not provided

Name	Type	Description	Arm Group Labels	Other Names
Rituximab	Drug
monoclonal antibodies	Drug