Prospective Trial of Rituximab for Primary Pulmonary Alveolar Proteinosis (NCT00552461) | Clinical Trial Compass
CompletedPhase 2
Prospective Trial of Rituximab for Primary Pulmonary Alveolar Proteinosis
United States10 participantsStarted 2007-01
Plain-language summary
The purpose of this study is to determine whether the use of rituximab is effective in treating pulmonary alveolar proteinosis by leading to an improvement in lung function and disease status.
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* Diagnosis of primary PAP (new or chronic) with presence of anti-GM-CSF antibody
* Moderately symptomatic disease with PaO2 \<70 on room air and on less than 6 L/min oxygen
* Able to give written informed consent and comply with the requirements of the study
* Adequate renal and liver function
* Negative serum pregnancy test (for women of child bearing age) and on acceptable birth control during and after study completion
Exclusion Criteria:
* Severe PAP and requires in-patient care and more urgent therapy with bilateral whole lung lavage
* Treatment with any investigational agent within 4 weeks of screening
* History of severe allergic or anaphylactic reactions to humanized or murine monoclonal antibodies
* History of HIV, recurrent significant infection or recurrent bacterial infections
* Known active bacterial, viral, fungal, mycobacterial, or other infection
* Ongoing use of high dose steroids (\>10mg/day) or unstable steroid dose
* Significant cardiac or pulmonary disease or blood disorder
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Evaluate symptomatic, physiologic and radiographic effects of therapy