Waldenstrom's MacroglobulinemiaNCT00142155
Correlation of FC Gamma RIIIA Receptor Response in Patients With Waldenstrom's Macroglobulinemia
A study testing Rituximab and monoclonal antibodies in people with Waldenstrom's Macroglobulinemia, run by Dana-Farber Cancer Institute at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 30 to 90 years
- Conditions the study is for
- Waldenstrom's Macroglobulinemia
- What is being tested?
- Rituximab and monoclonal antibodies
- How many people
- 300 participants
- Where
- 1 siteUnited States
- Study dates
- Jan 2002to Mar 2007
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 30 to 90 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients treated with rituximab or other monoclonal antibodies for Waldenstrom's macroglobulinemia
Who cannot join
None listed.
Trial locations and contacts
1 site in 1 country.
United States1 site
Dana-Farber Cancer Institute
Boston, Massachusetts, 02115
About this study
Official title: Correlation of Fc Gamma RIIIA Receptor Expression and Response to Rituximab and Other Monoclonal Antibodies in Patients With Waldenstrom's Macroglobulinemia
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.
Read the 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.
- Conditions
- Waldenstrom's Macroglobulinemia
- Being tested
- Rituximab, monoclonal antibodies
- Keywords
- monoclonal antibody, Fc gamma RIII receptor expression, rituximab
- Medical subject headings
- Waldenstrom Macroglobulinemia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
RituximabDrug
monoclonal antibodiesDrug
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Sep 2005 (estimated)
- Study startJan 2002
- Primary completionMar 2007
- Study completionMar 2007
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Waldenstrom's MacroglobulinemiaStudies of the same condition, open and under way.
- More trials run by Dana-Farber Cancer InstituteThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Enrolment
- 300 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Dana-Farber Cancer Institute
- Sponsor type
- University, hospital or other
- Investigators
- Steven Treon, MD, MA, PhD, Principal investigator, Dana-Farber Cancer Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00142155
- Sponsor's protocol ID
- 02-075
- Status last verified
- Jun 2011
- First submitted
- 1 Sep 2005
- Last updated
- 27 Jun 2011
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Jun 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Correlation of Fc Gamma RIIIA Receptor Expression and Response to Rituximab and Other Monoclonal Antibodies in Patients With Waldenstrom's Macroglobulinemia
- ClinicalTrials.gov ID
- NCT00142155
- Acronym / sponsor ID
- 02-075
- Conditions
- Waldenstrom's Macroglobulinemia
- Keywords
- monoclonal antibody, Fc gamma RIII receptor expression, rituximab
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 300 participants (estimated)
- Lead sponsor
- Dana-Farber Cancer InstituteUniversity, hospital or other
- Study start
- Jan 2002
- Primary completion
- Mar 2007 (actual)
- Study completion
- Mar 2007 (actual)
- First posted
- 2 Sep 2005 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
Who may qualify
- Ages
- 30 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Patients treated with rituximab or other monoclonal antibodies for Waldenstrom's macroglobulinemia
Key exclusion criteria (0 listed)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Rituximab | Drug | – |
| monoclonal antibodies | Drug | – |
Primary outcome
Not reported in the source record.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Jun 2011.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Steven Treon, MD, MA, PhD principal investigator
Dana-Farber Cancer Institute
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Rituximab and monoclonal antibodies in people with Waldenstrom's Macroglobulinemia, run by Dana-Farber Cancer Institute at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 0 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 27 Jun 2011. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Jun 2011.