NCT03500731

Lung and Bone Marrow Transplantation for Lung and Bone Marrow Failure

Lung Transplant in Tandem With Bone Marrow Transplant for Combined Lung and Bone Marrow Failure

• Status: Recruiting
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 8 (estimated)
• Sponsor: Paul Szabolcs · Academic / Other
• Sex: All
• Age: 18 Years – 60 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this study is to determine whether a lung transplantation prior to bone marrow transplantation (BMT) would allow for restoration of pulmonary function prior to BMT, allowing to proceed to BMT, to restore hematologic function.

Detailed description

The primary purpose of the study is to evaluate the safety and efficacy of performing lung transplantation followed by cadaveric, partially HLA-matched (≥1/6 HLA-match with an identical ABO blood type) CD3+/CD19+ depleted bone marrow transplantation in bone marrow failure and end-stage lung disease. Idiopathic pulmonary fibrosis (IPF) is a chronic, progressive, and fatal interstitial lung disease for which lung transplantation is the only therapy shown to prolong survival. Given the association of IPF with hematologic cytopenias and bone marrow failure, it is proposed that a tandem lung transplantation and bone marrow transplantation from a single cadaveric donor could be successful. This protocol focuses on performing combined transplantation for candidates that are unable to undergo standard lung transplantation. Lung transplantation prior to bone marrow transplantation (BMT) would allow for restoration of pulmonary function prior to BMT, and to restore hematologic function post BMT transplantation. The secondary objectives are to evaluate the feasibility and long-term complications associated with combined solid organ and BMT including the ability to initiate and successfully withdraw from immunosuppression following BMT and to attain independence from growth factors, red blood cell or platelet transfusions.

Conditions

• Idiopathic Pulmonary Fibrosis
• Emphysema or COPD

Interventions

Type	Name	Description
BIOLOGICAL	CD3/CD19 negative hematopoietic stem cells	Negative selection for CD3/CD19 will be performed on CliniMACS® depletion device and given at time no less than 8 weeks post lung transplantation
DRUG	Rituximab	Transplantation Conditioning
DRUG	Alemtuzumab	Transplantation Conditioning
DRUG	Fludarabine	Transplantation Conditioning
DRUG	Thiotepa	Transplantation Conditioning
DRUG	G-CSF	Transplantation conditioning
DRUG	Hydroxyurea	Transplantation Conditioning

Timeline

• Start date: 2018-04-19
• Primary completion: 2027-12-01
• Completion: 2028-12-01
• First posted: 2018-04-18
• Last updated: 2026-01-13

Locations

2 sites across 1 country: United States

Regulatory

• FDA-regulated drug study