Status:
WITHDRAWN
Lung Transplant Plasmapheresis/Belatacept/Carfilzomib for Antibody Mediated Rejection and Desensitization
Lead Sponsor:
Duke University
Collaborating Sponsors:
Bristol-Myers Squibb
Conditions:
Lung Transplant Rejection
Antibody-mediated Rejection
Eligibility:
All Genders
18+ years
Phase:
PHASE2
Brief Summary
Antibody mediated rejection (AMR) post transplant contributes to poor long term outcomes after lung transplantation. Additionally, high antibodies detected pre transplant in candidates limit donor ava...
Detailed Description
Antibody mediated rejection (AMR) post transplant contributes to poor long term outcomes after lung transplantation. Additionally, high antibodies detected pre transplant in candidates limit donor ava...
Eligibility Criteria
Inclusion
- Inclusion Criteria:
- Inclusion criteria for the AMR post-transplant cohort
- Positive DSAs and allograft dysfunction defined by changes in pulmonary physiology, gas exchange, radiological features or deteriorating functional performance that is highly suspicious for AMR
- Recipient is Epstein-Barr virus positive (EBV+) by serology
- Ability to provide signed and dated IRB approved written consent in accordance with regulatory and institutional guidelines prior to any protocol-related procedure
- Inclusion criteria for the pre-transplant desensitization cohort
- Elevated HLA antibodies (defined as MFI \>1000) such that the calculated panel reactive antibodies are \>60%
- At least 2 HLA antibodies with Mean Fluorescent Intensity (MFI) \<10,000 and at least 2 HLA antibodies with MFI \<5,000 on undiluted serum that do not demonstrate an increase in MFI with dilution at 1:16 (no evidence of a prozone effect).
- EBV+ by serology
- Clinically stable defined by not on invasive mechanical ventilation, extracorporeal membrane oxygenation support or other invasive life support requiring ICU level of care
- Ability to provide signed and dated IRB approved written consent in accordance with regulatory and institutional guidelines prior to any protocol-related procedure
- Exclusion criteria for both AMR post-transplant cohort and pre-transplant cohort
- Active systemic infection
- Allergy to carfilzomib or belatacept
- Known malignancy in the previous 2 years except for non-melanomatous skin cancer
- Pregnancy
- Inability to commit to complete treatment protocol at Duke as all procedures must be completed at Duke
- Prisoners or those who are compulsory detained
Exclusion
Key Trial Info
Start Date :
May 1 2019
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
October 30 2020
Estimated Enrollment :
Patients enrolled
Trial Details
Trial ID
NCT03805178
Start Date
May 1 2019
End Date
October 30 2020
Last Update
May 2 2019
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