LAMBDA 002 (Lung Registry) Study

Lung Transplant Rejection Clinical Trial

Official title:

Observational Registry Study With Sub-analysis (Patients Previously Randomized to LAMBDA 001) to Assess ProsperaTM Performance for Detection of CLAD After Lung Transplant (LAMBDA 002)

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT05170425
• Other study ID #: 21-055-TRP
• Status: Active, not recruiting
• Start date: November 4, 2022
• Est. completion date: May 2027

Study information

• Verified date: April 2024
• Source: Natera, Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial Summary

The LAMBDA 002 registry study is an observational, longitudinal, multi-center study observing patients undergoing lung transplant.

Description:

The LAMBDA 002 registry study is an observational, longitudinal, multicenter study observing patients undergoing lung transplant in one of the following two cohorts:

Cohort 1: Previously enrolled and randomized in LAMBDA 001 (transbronchial biopsy surveillance or Prospera surveillance) and enrolled at least 12 and up to 18 months post-transplant.

Cohort 2: Not previously randomized in LAMBDA 001 (may have been enrolled but randomization did not occur), Prospera testing is part of clinical care and enrolled during less than or equal to 12 months posttransplant.

Primary Objective:

The primary objective of the study is to assess the clinical utility of combining Prospera testing with routine transplant management in detecting acute rejection or infection events in patients receiving Prospera testing as part of their post-transplant clinical care.

Secondary Objectives:

The secondary objectives of the study are to:

1. Determine whether Prospera can detect AR (acute rejection) and/or infection earlier than standard clinical indicators used concurrently during the study.

2. Evaluate Prospera's ability to differentiate between rejection and infectious injuries for single and repeat episodes of bacterial, viral, mycobacterial and fungal infections.

3. Evaluate changes in Prospera dd-cfDNA as an indicator for biopsy proven acute rejection (BPAR), graft failure, death, development of donor-specific antibodies (DSA), chronic lung allograft dysfunction (CLAD), infection episodes and response to treatment for rejection.

4. Evaluate changes in Prospera dd-cfDNA in assessments involving standard management for acute rejection and infection events.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 154
• Est. completion date: May 2027
• Est. primary completion date: August 2026
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Patients must meet all the following selection criteria to be eligible for the study:

Inclusion Criteria

1. Age 18 or older at the time of enrollment.

2. Underwent a first single or bilateral deceased-donor lung transplant. 3) Allograft was from a genetically different donor (e.g., not an identical twin).

4) Meets criteria for one of the two study cohorts:

a) Cohort 1: i) Previously enrolled and randomized in LAMBDA 001 (TBBx surveillance or Prospera surveillance) AND ii) Enrolled at least 12 and up to 18 months post-transplant b) Cohort 2: i) Not previously randomized in LAMBDA 001 (may have been enrolled if randomization did not occur) AND ii) Enrolled less than or equal to 12 months post-transplant 5) Prospera testing is planned as part of routine post-transplant management.

Exclusion Criteria

Patients are not eligible for the study if they meet any of the following criteria:

1) Recipient of multi-organ transplant at the time of lung transplant. 2) Prior recipient of any solid organ or hematopoietic (bone marrow or stem cell) transplant.

3) Human immunodeficiency virus (HIV) infection. 4) Pregnant. 5) Ongoing testing with another allograft dd-cfDNA assessment test is planned. 6) Unwilling or unable to provide informed consent. 7) Unwilling or unable to comply with study procedures.

Related Conditions & MeSH terms

• Lung Transplant Rejection

Intervention

Device:
• Prospera
Prospera™ detects allograft rejection noninvasively and with high accuracy by measuring the fraction of donor derived cell-free DNA (dd-cfDNA) in the patient's blood, without the need for prior donor or recipient genotyping. Prospera is a commercially available Laboratory Developed Test (LDT) certified under the Clinical Laboratory Improvement Amendments (CLIA). This test has not been cleared or approved by the U.S. Food and Drug Administration (FDA).

Locations

Country	Name	City	State
United States	Johns Hopkins Hospital	Baltimore	Maryland
United States	Cedars-Sinai Medical Center	California City	California
United States	Northwestern Memorial Hospital	Chicago	Illinois
United States	Ohio State University Medical Center	Columbus	Ohio
United States	UT Southwestern Medical Center	Dallas	Texas
United States	Corewell Health	Grand Rapids	Michigan
United States	Baylor College of Medicine Medical Center	Houston	Texas
United States	Houston Methodist Hospital	Houston	Texas
United States	Columbia University Irving Medical Center	New York	New York
United States	Washington University School of Medicine	Saint Louis	Missouri
United States	University of Washington	Seattle	Washington

Sponsors (1)

Lead Sponsor	Collaborator
Natera, Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Percent of donor-derived cell-free DNA (ddcfDNA) measured via the Prospera test		3 years