Idiopathic Pulmonary FibrosisPhase 1/2NCT03500731
Lung and Bone Marrow Transplantation for Lung and Bone Marrow Failure
A Phase 1/2 study testing CD3/CD19 negative hematopoietic stem cells, Rituximab and Alemtuzumab in people with Idiopathic Pulmonary Fibrosis and Emphysema or COPD, run by Paul Szabolcs at 2 sites in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 60 years
- Conditions the study is for
- Idiopathic Pulmonary Fibrosis, Emphysema or COPD
- What is being tested?
- CD3/CD19 negative hematopoietic stem cells, Rituximab and Alemtuzumab
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 8 participants
- Where
- 2 sitesUnited States
- Study dates
- 19 Apr 2018to Dec 2028
- Phase
- Phase 1/2
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Individuals must meet all of the following criteria in order to be eligible for this study.
- Subject must be able to understand and provide informed consent.
- Male or female, 18 through 60 years old, inclusive, at the time of informed consent.
- Meet criteria for UNOS listing for lung transplantation.
- Patients must have evidence of end stage lung disease. Examples of such diseases include but are not limited to:
- Pulmonary Fibrosis
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- COPD/Emphysema
- Patients must have evidence of bone marrow failure with abnormal low cell count in at least one hematopoietic line, making the patient a poor candidate for long-term immunosuppressive therapy. Eligible patients must meet at least one of the following criteria:
- Unexplained, non-drug induced neutropenia with absolute neutrophils counts of <1500/µL the previous year, confirmed by repeat testing
- Unexplained, non-drug induced thrombocytopenia with mean platelets counts of <100,000/µL the previous year, confirmed by repeat testing
- Unexplained, non-hemolytic anemia, with a hemoglobin level of < 12 g/dL the previous year, confirmed by repeat testing
- GFR ≥45 mL/min/1.73 m2.
- AST, ALT ≤4x upper limit of normal, total bilirubin ≤ 2.5 mg/dL, normal INR, albumin >3.0 g/dL
- Cardiac ejection fraction ≥ 40% or shortening fraction ≥26%.
- Negative pregnancy test for females, unless surgically sterilized.
- All females of childbearing potential and sexually active males must agree to use a FDA approved method of birth control for up to 24 months after BMT or for as long as they are taking any medication that may harm a pregnancy, an unborn child or may cause birth defect.
- Subject will also be counseled regarding the potential risks of infertility following BMT and advised to discuss sperm banking or oocyte harvesting.
Who cannot join
- Individuals who meet any of these criteria are not eligible for this study.
- Inability or unwillingness of a participant to give written informed consent or comply with study protocol.
- Patients who have underlying malignant conditions.
- Patients who have non-malignant conditions not requiring BMT.
- HIV positive by serology or PCR, HTLV positive by serology. If HTLV serology is positive, it will be confirmed by nucleic acid testing (NAT). If HTLV NAT is negative, subject will remain eligible regardless of HTLV serology result.
- Females who are pregnant or who are lactating.
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- Allergy to DMSO or any other ingredient used in the manufacturing of the stem cell product.
- Uncontrolled pulmonary infection, as determined by radiographic findings and/or significant clinical deterioration. NOTE: Pulmonary colonization with multiple organisms is common and will not be considered an exclusion criterion.
- Uncontrolled infection, as determined by the appropriate imaging and/or confirmatory testing e.g. blood cultures, PCR testing, etc.
- Recent recipient of any licensed or investigational live attenuated vaccine(s) within 4 weeks of transplant.
- Past or current medical problems or findings from physical examination or laboratory testing that are not listed above, which, in the opinion of the investigator, may pose additional risks from participation in the study, may interfere with the participant's ability to comply with study requirements or that may impact the quality or interpretation of the data obtained from the study.
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
United States2 sites, 2 recruiting
- Recruiting
UPMC Presbyterian
Pittsburgh, Pennsylvania, 15214
John McDyer, MD, 412-648-6161, mcdyerjf@upmc.edu
- Recruiting
Children's Hospital of Pittsburgh of UPMC
Pittsburgh, Pennsylvania, 15224
Shawna H McIntyre, RN, 412-692-5552, mcintyresm@upmc.edu
Paul Szabolcs, MD
About this study
Official title: Lung Transplant in Tandem With Bone Marrow Transplant for Combined Lung and Bone Marrow Failure
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.
Read the 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
- Being tested
- CD3/CD19 negative hematopoietic stem cells, Rituximab, Alemtuzumab, Fludarabine, Thiotepa
- Keywords
- Lung Transplantation, Stem Cell Transplantation, Idiopathic Pulmonary Fibrosis, Emphysema or COPD, Bone marrow transplantation, Cadaveric donor, Unrelated donor, HLA-Mismatch, BMT, HSCT, IPF, Pulmonary fibrosis
- Medical subject headings
- Idiopathic Pulmonary Fibrosis, Emphysema, Pulmonary Disease, Chronic Obstructive, Pulmonary Fibrosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CD3/CD19 negative hematopoietic stem cellsBiological
Negative selection for CD3/CD19 will be performed on CliniMACS® depletion device and given at time no less than 8 weeks post lung transplantation
RituximabDrug
Also called Rituxan
Transplantation Conditioning
AlemtuzumabDrug
Also called Campath-1H
Transplantation Conditioning
FludarabineDrug
Also called Fludara, Oforta
Transplantation Conditioning
ThiotepaDrug
Transplantation Conditioning
G-CSFDrug
Also called Neupogen, Granix, Zarxio, Filgrastim
Transplantation conditioning
HydroxyureaDrug
Transplantation Conditioning
| Study group | Role | What they receive |
|---|---|---|
| Lung and Bone Marrow Transplantation | Experimental | All patients will undergo a cadaveric, partially HLA-matched lung transplantation followed by a CD3+/CD19+ depleted BMT from the same donor. In this study, the investigators will use a ≥1/6 HLA-matched T cell depleted bone marrow transplantation from a cadaveric organ donor with an identical ABO blood type as the recipient. Prior to transplantation, the marrow will be negatively selected for CD3/CD19 using a CliniMACS® depletion device.
Subjects will undergo lung transplantation utilizing standard induction regimens selected by the CO-PIs based on the subject's underlying comorbidities and allosensitization. Rituximab may be initiated prior to the lung transplantation with tacrolimus as the ongoing maintenance immunosuppression.
Subjects will undergo BMT utilizing CD3+/CD19+-depleted bone marrow with bone marrow conditioning beginning no less than 8 weeks after lung transplantation. Bone marrow will be recovered alongside solid organs and will be processed and cryopreserved. Receives: Biological: CD3/CD19 negative hematopoietic stem cells; Drug: Rituximab; Drug: Alemtuzumab; Drug: Fludarabine; Drug: Thiotepa; Drug: G-CSF; Drug: Hydroxyurea |
What is being measured
The primary outcome is the main question the study is designed to answer.
Death
How many, if any, patients die
Measured: Up to 2 years post stem cell transplant
Engraftment failure
How many, if any, develop engraftment failure
Measured: Up to 2 years post stem cell transplant
Non-hematologic events
Any Grade 4 event that happens at any time points
Measured: Up to 2 years post stem cell transplant
Hematological events
Any Grade 4 hematological events
Measured: after 30 days post stem cell transplant
BOS Score
Bronchiolitis Obliterans Syndrome (BOS) score based off patient pulmonary function testing. Graded on scale (BOS0 to BOS3), BOS0 having a better outcome then BOS3
Measured: at 1 year post lung transplant
T-cell Chimerism
The number of patients who have ≥25% donor T-cell chimerism
Measured: at 12 months post stem cell transplant
Myeloid chimerism
The number of patients with myeloid disorders who attain ≥ 10% myeloid chimerism
Measured: at 12 months post stem cell transplant
Restoration of blood cell count (in absence of growth factors)
Absolute neutrophil count (ANC)≥1000 per microliter of blood, platelets ≥50000 per microliter of blood and hematocrit ≥8 grams per deciliter of blood
Measured: at 12 months post stem cell transplant
Secondary outcomes (13)
Feasibility of patients able to proceed to BMT within 6 months following lung transplantation
The number of patients who are able to proceed to BMT within 6 months following lung transplantation
Measured: Up to 2 years post stem cell transplant
Independence
The number of patients who are able to be independent from transfusions and growth factors for at least 7 days
Measured: up to 2 years post stem cell transplant
Independence
The number of patients who are able to be independent from transfusions and growth factors for at least 1 month
Measured: Up to 2 years post stem cell transplant
Tolerance development to both host and pulmonary grafting
Development of tolerance to both the host and pulmonary graft
Measured: Up to 2 years post stem cell transplant
Long-term complications
Long-term complications of combined solid organ and BMT
Measured: Up to 2 years post stem cell transplant
Acute cellular rejection
The number of patients who develop acute cellular rejection
Measured: Up to 2 years post stem cell transplant
Acute graft-versus-host-disease (GVHD)
The number of patients who develop acute graft-versus-host-disease (GVHD)
Measured: Up to 2 years post stem cell transplant
Chronic graft-versus-host-disease (GVHD)
The number of patients who develop chronic graft-versus-host-disease (GVHD)
Measured: Up to 2 years post stem cell transplant
Ability to withdrawal immunosuppression
The number of patients who are able to start immunosuppression withdrawal.
Measured: By 1 year post stem cell transplant
Time to withdraw immunosuppression
Time from BMT to withdrawal of immunosuppression
Measured: Up to 2 years post stem cell transplant
Prophylactic antimicrobial drugs
Time from BMT to independence for prophylactic antimicrobial drugs
Measured: Up to 2 years post stem cell transplant
Treatment antimicrobial drugs
Time from BMT to independence from treatment antimicrobial drugs
Measured: up to 2 years post stem cell transplant
Chronic lung allograft dysfunction
The number of patients who develop chronic lung allograft dysfunction post lung transplant for all subjects, lung only and lung +stem cell transplant.
Measured: 1 year post lung transplant
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Apr 2018
- Study start19 Apr 2018
- Primary completionDec 2027 (estimated)
- Study completionDec 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Idiopathic Pulmonary FibrosisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1/2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 8 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Paul Szabolcs
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Paul Szabolcs, University of Pittsburgh
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03500731
- Sponsor's protocol ID
- STUDY19110120
- Status last verified
- Jan 2026
- First submitted
- 30 Mar 2018
- Last updated
- 13 Jan 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Lung Transplant in Tandem With Bone Marrow Transplant for Combined Lung and Bone Marrow Failure
- ClinicalTrials.gov ID
- NCT03500731
- Acronym / sponsor ID
- STUDY19110120
- Conditions
- Idiopathic Pulmonary Fibrosis, Emphysema or COPD
- Keywords
- Lung Transplantation, Stem Cell Transplantation, Idiopathic Pulmonary Fibrosis, Emphysema or COPD, Bone marrow transplantation, Cadaveric donor, Unrelated donor, HLA-Mismatch
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 8 participants (estimated)
- Lead sponsor
- Paul SzabolcsUniversity, hospital or other
- Study start
- 19 Apr 2018 (actual)
- Primary completion
- Dec 2027 (estimated)
- Study completion
- Dec 2028 (estimated)
- First posted
- 18 Apr 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Lung and Bone Marrow Transplantation | Experimental | Biological: CD3/CD19 negative hematopoietic stem cells, Drug: Rituximab, Drug: Alemtuzumab, Drug: Fludarabine, Drug: Thiotepa, Drug: G-CSF, Drug: HydroxyureaAll patients will undergo a cadaveric, partially HLA-matched lung transplantation followed by a CD3+/CD19+ depleted BMT from the same donor. In this study, the investigators will use a ≥1/6 HLA-matched T cell depleted bone marrow transplantation from a cadaveric organ donor with an identical ABO blood type as the recipient. Prior to transplantation, the marrow will be negatively selected for CD3/CD19 using a CliniMACS® depletion device. Subjects will undergo lung transplantation utilizing standard induction regimens selected by the CO-PIs based on the subject's underlying comorbidities and allosensitization. Rituximab may be initiated prior to the lung transplantation with tacrolimus as the ongoing maintenance immunosuppression. Subjects will undergo BMT utilizing CD3+/CD19+-depleted bone marrow with bone marrow conditioning beginning no less than 8 weeks after lung transplantation. Bone marrow will be recovered alongside solid organs and will be processed and cryopreserved. |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (17 listed)
- Individuals must meet all of the following criteria in order to be eligible for this study.
- Subject must be able to understand and provide informed consent.
- Male or female, 18 through 60 years old, inclusive, at the time of informed consent.
- Meet criteria for UNOS listing for lung transplantation.
- Patients must have evidence of end stage lung disease. Examples of such diseases include but are not limited to:
Key exclusion criteria (11 listed)
- Individuals who meet any of these criteria are not eligible for this study.
- Inability or unwillingness of a participant to give written informed consent or comply with study protocol.
- Patients who have underlying malignant conditions.
- Patients who have non-malignant conditions not requiring BMT.
- HIV positive by serology or PCR, HTLV positive by serology. If HTLV serology is positive, it will be confirmed by nucleic acid testing (NAT). If HTLV NAT is negative, subject will remain eligible regardless of HTLV serology result.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| CD3/CD19 negative hematopoietic stem cellsNegative selection for CD3/CD19 will be performed on CliniMACS® depletion device and given at time no less than 8 weeks post lung transplantation | Biological | Lung and Bone Marrow Transplantation |
| RituximabAlso: RituxanTransplantation Conditioning | Drug | Lung and Bone Marrow Transplantation |
| AlemtuzumabAlso: Campath-1HTransplantation Conditioning | Drug | Lung and Bone Marrow Transplantation |
| FludarabineAlso: Fludara, OfortaTransplantation Conditioning | Drug | Lung and Bone Marrow Transplantation |
| ThiotepaTransplantation Conditioning | Drug | Lung and Bone Marrow Transplantation |
| G-CSFAlso: Neupogen, Granix, Zarxio, FilgrastimTransplantation conditioning | Drug | Lung and Bone Marrow Transplantation |
| HydroxyureaTransplantation Conditioning | Drug | Lung and Bone Marrow Transplantation |
Primary outcome
Death
Time frame: Up to 2 years post stem cell transplant
How many, if any, patients die
Engraftment failure
Time frame: Up to 2 years post stem cell transplant
How many, if any, develop engraftment failure
Non-hematologic events
Time frame: Up to 2 years post stem cell transplant
Any Grade 4 event that happens at any time points
Hematological events
Time frame: after 30 days post stem cell transplant
Any Grade 4 hematological events
BOS Score
Time frame: at 1 year post lung transplant
Bronchiolitis Obliterans Syndrome (BOS) score based off patient pulmonary function testing. Graded on scale (BOS0 to BOS3), BOS0 having a better outcome then BOS3
T-cell Chimerism
Time frame: at 12 months post stem cell transplant
The number of patients who have ≥25% donor T-cell chimerism
Myeloid chimerism
Time frame: at 12 months post stem cell transplant
The number of patients with myeloid disorders who attain ≥ 10% myeloid chimerism
Restoration of blood cell count (in absence of growth factors)
Time frame: at 12 months post stem cell transplant
Absolute neutrophil count (ANC)≥1000 per microliter of blood, platelets ≥50000 per microliter of blood and hematocrit ≥8 grams per deciliter of blood
13 secondary outcomes
Feasibility of patients able to proceed to BMT within 6 months following lung transplantation
Time frame: Up to 2 years post stem cell transplant
Independence
Time frame: up to 2 years post stem cell transplant
Independence
Time frame: Up to 2 years post stem cell transplant
Tolerance development to both host and pulmonary grafting
Time frame: Up to 2 years post stem cell transplant
Long-term complications
Time frame: Up to 2 years post stem cell transplant
Acute cellular rejection
Time frame: Up to 2 years post stem cell transplant
Acute graft-versus-host-disease (GVHD)
Time frame: Up to 2 years post stem cell transplant
Chronic graft-versus-host-disease (GVHD)
Time frame: Up to 2 years post stem cell transplant
Ability to withdrawal immunosuppression
Time frame: By 1 year post stem cell transplant
Time to withdraw immunosuppression
Time frame: Up to 2 years post stem cell transplant
Prophylactic antimicrobial drugs
Time frame: Up to 2 years post stem cell transplant
Treatment antimicrobial drugs
Time frame: up to 2 years post stem cell transplant
Chronic lung allograft dysfunction
Time frame: 1 year post lung transplant
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Jan 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing CD3/CD19 negative hematopoietic stem cells, Rituximab and Alemtuzumab in people with Idiopathic Pulmonary Fibrosis and Emphysema or COPD, run by Paul Szabolcs at 2 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 17 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 13 Jan 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Paul Szabolcs, M.D. (412-692-5427, Paul.Szabolcs@chp.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Death (time frame: Up to 2 years post stem cell transplant). The study lists 8 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Jan 2026.