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Prospective Trial of Rituximab for Primary Pulmonary Alveolar Proteinosis (PAP)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00552461
Recruitment Status : Unknown
Verified May 2008 by East Carolina University.
Recruitment status was:  Recruiting
First Posted : November 2, 2007
Last Update Posted : May 9, 2008
Sponsor:
Collaborator:
Genentech, Inc.
Information provided by:
East Carolina University

Tracking Information
First Submitted Date  ICMJE October 31, 2007
First Posted Date  ICMJE November 2, 2007
Last Update Posted Date May 9, 2008
Study Start Date  ICMJE January 2007
Estimated Primary Completion Date July 2009   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: October 31, 2007)
Evaluate symptomatic, physiologic and radiographic effects of therapy [ Time Frame: 6-months ]
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: October 31, 2007)
Evaluate the overall tolerability of therapy and the requirement for therapeutic whole-lung lavage [ Time Frame: 6-months ]
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Prospective Trial of Rituximab for Primary Pulmonary Alveolar Proteinosis
Official Title  ICMJE Prospective Open-Label Trial of Rituximab for Primary Pulmonary Alveolar Proteinosis
Brief 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.
Detailed Description The goal of this study is to conduct a prospective, open-label 6-month trial of rituximab in patients who present with symptomatic primary or idiopathic PAP. A total of 10 subjects with primary PAP will be enrolled over 12 months at East Carolina University. Patients over age 18 with a clinical diagnosis of moderate symptomatic idiopathic PAP, established by appropriate clinical history, radiographic and physiologic findings, presence of circulating anti-GM-CSF antibody, and confirmatory findings on bronchoscopy with bronchoalveolar lavage and/or open-lung biopsy will be recruited. Patients with newly diagnosed PAP or established disease may be considered for this study.
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE
  • Pulmonary Alveolar Proteinosis
  • Primary Disease
Intervention  ICMJE Drug: rituximab
IV, 1000 mg, two weeks, 2 times
Other Names:
  • Rituxan
  • MabThera
Study Arms  ICMJE Experimental: 1
Intervention: Drug: rituximab
Publications * Kavuru MS, Malur A, Marshall I, Barna BP, Meziane M, Huizar I, Dalrymple H, Karnekar R, Thomassen MJ. An open-label trial of rituximab therapy in pulmonary alveolar proteinosis. Eur Respir J. 2011 Dec;38(6):1361-7. doi: 10.1183/09031936.00197710. Epub 2011 Apr 8.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Unknown status
Estimated Enrollment  ICMJE
 (submitted: October 31, 2007)
10
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE December 2009
Estimated Primary Completion Date July 2009   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00552461
Other Study ID Numbers  ICMJE U2990s
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Mani S. Kavuru, MD, Prinicipal Investigator, Professor and Division Chief Pulmonary & CCM, East Carolina University
Study Sponsor  ICMJE East Carolina University
Collaborators  ICMJE Genentech, Inc.
Investigators  ICMJE
Principal Investigator: Mani S Kavuru, MD East Carolina University
PRS Account East Carolina University
Verification Date May 2008

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP