RECRUITING

LAM-001 in Lung Transplant Recipients With Bronchiolitis Obliterans Syndrome.

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Conditions

Bronchiolitis Obliterans SyndromeChronic Lung Allograft DysfunctionLung TransplantationLung Transplant RejectionSirolimusmTOR inhibitorCLAD

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

The goal of this clinical trial is to learn about the safety and effectiveness of LAM-001 in patients who have developed bronchiolitis obliterans syndrome (BOS), a form of chronic rejection, after lung transplantation. The main questions it aims to answer are: * Is LAM-001 safe in these patients? * Is LAM-001 effective in slowing BOS progression? Participants will: * Be randomly assigned to inhale either LAM-001 or placebo (a look-alike substance that contains no active drug) daily for 48 weeks * Attend 10 study visits (mixture of in-person and telehealth) over the 48 week period * Undergo pulmonary function testing, bronchoscopy, lab testing, and physical examination * Submit weekly home spirometry monitoring Researchers will compare participants assigned to LAM-001 versus placebo to see if LAM-001 is safely tolerated and to assess the effectiveness of LAM-001 on slowing BOS progression.

Official Title

A Randomized, Placebo-controlled Phase 2 Study to Demonstrate the Safety and Efficacy of the Addition of LAM-001 to Standard Immunosuppression Therapy for Chronic Lung Allograft Dysfunction (BOS).

Quick Facts

Study Start:2023-08-17
Study Completion:2025-12
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT06018766

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. * Age \> 18 years old
  2. * Recipient of a double pulmonary allograft at least 12 months before study entry
  3. * Subjects with clinically diagnosed CLAD-BOS phenotype (all 3 required)
  4. * BOS defined as screening FEV1 between 85-51% of the baseline as defined by the 2 highest FEV1 measures at least 3 weeks apart.
  5. * Diagnosis within 12 months of screening visit.
  6. * FEV1 decline is persistent as defined by decline sustained for \> 30 days.
  7. * Currently receiving Standard Immunosuppression. This is defined as a combination of 3 medications including Prednisone, Mycophenolate or Azathioprine, and Tacrolimus or Cyclosporine. The dosing should be stable for 4 weeks prior to screening.
  8. * Absence of oral sirolimus or everolimus treatment for at least 4 weeks prior to screening based on the half-life and resolution of the tissue effects
  9. * Stable enough to enable routine post-transplant bronchoscopy with BAL and biopsy when indicated
  10. * Capable of understanding the purposes and risks of the study
  11. * Written informed consent (and assent when applicable) obtained from subject or subject's legal representative and ability for subject to comply with the requirements of the study.
  12. * Women of childbearing potential must have a negative serum pregnancy test within 7 days prior to study entry
  13. * Women of childbearing potential if sexually active must agree to using highly effective contraception during study and for 90 days after discontinuation of study treatment
  14. * Women of childbearing potential must refrain from breast feeding or donating eggs for the duration of the study and for 90 days after the last dose of study treatment
  15. * Male participants must agree to use a condom during sexual contact with a female of childbearing potential while participating in the study and for 90 days following discontinuation of investigational product use
  16. * Male participants must refrain from donating sperm for the duration of the study and for 90 days after the last dose of study treatment
  1. * Pregnant, breastfeeding, or unwilling to practice birth control during participation in the study.
  2. * Presence of a condition or abnormality that in the opinion of the Investigator would compromise the safety of the patient or the quality of the data.
  3. * Patients with re-transplantation or currently listed for re-transplantation
  4. * Patients with confirmed other causes for loss of lung function, such as acute infection, acute rejection, restrictive allograft syndrome (CLAD - RAS phenotype, see Protocol Specific Definition), etc.
  5. * Patients with acute antibody-mediated rejection at Screening. In this context, clinically stable patients (as judged by the Investigator) with detectable donor-specific antibodies (DSA) levels at the Screening Visit are eligible for the study
  6. * Active acute bacterial, viral, or fungal infection that has not successfully resolved in at least 4 weeks prior to the Screening Visit. Patients with chronic infection or colonization who are clinically stable as per judgement of the investigator are eligible.
  7. * Mechanical ventilation within 12 weeks prior to the randomization
  8. * Patient has baseline resting oxygen saturation of \< 89% on room air or use of supplemental oxygen at rest at screening
  9. * Evidence of functional airway stenosis (i.e., bronchomalacia/ tracheomalacia, airway stents, or airways requiring balloon dilatations to maintain patency) with onset after the initial diagnosis of BOS and ongoing at Screening and/or Baseline Visit
  10. * Known hypersensitivity to sirolimus or everolimus
  11. * Currently enrolled in another investigational trial for obstructive chronic lung allograft dysfunction (BOS)
  12. * Patients with chronic renal failure, defined as serum creatinine \> 2.5 mg/dL at screening, or requiring chronic dialysis
  13. * Patients with liver disease and serum bilirubin \> 3-fold upper limit of normal range or transaminases \> 2.5 upper limit of normal range
  14. * Patients with active malignancy within the previous 2 years, including post-transplant lymphoproliferative disorder, except for treated, localized basal and squamous cell carcinomas
  15. * Any history of malignancy likely to result in significant disability or likely to require significant medical or surgical intervention within the next 6 months. This does not include minor surgical procedures for localized skin cancer.
  16. * History of severe allergic reaction to lactose (patients with lactose intolerance are eligible)
  17. * Patients with uncontrolled hypertension

Contacts and Locations

Study Contact

Steven Hays, MD
CONTACT
415-336-4141
steven.hays@ucsf.edu

Principal Investigator

Steven Hays, MD
PRINCIPAL_INVESTIGATOR
University of California, San Francisco

Study Locations (Sites)

University of California, San Francisco
San Francisco, California, 94143
United States

Collaborators and Investigators

Sponsor: Steven Hays, MD

  • Steven Hays, MD, PRINCIPAL_INVESTIGATOR, University of California, San Francisco

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2023-08-17
Study Completion Date2025-12

Study Record Updates

Study Start Date2023-08-17
Study Completion Date2025-12

Terms related to this study

Keywords Provided by Researchers

  • Bronchiolitis Obliterans Syndrome
  • Chronic Lung Allograft Dysfunction
  • Lung Transplant Rejection
  • Sirolimus
  • mTOR inhibitor
  • CLAD

Additional Relevant MeSH Terms

  • Bronchiolitis Obliterans Syndrome
  • Chronic Lung Allograft Dysfunction
  • Lung Transplantation