Lung and Bone Marrow Transplantation for Lung and Bone Marrow Failure (NCT03500731) | Clinical Trial Compass
RecruitingPhase 1/2
Lung and Bone Marrow Transplantation for Lung and Bone Marrow Failure
United States8 participantsStarted 2018-04-19
Plain-language 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.
Who can participate
Age range18 Years – 60 Years
SexALL
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Inclusion criteria
✓. 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:
✓. 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:
✓. 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%.
Exclusion criteria
✕. 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.
What they're measuring
1
Death
Timeframe: Up to 2 years post stem cell transplant
2
Engraftment failure
Timeframe: Up to 2 years post stem cell transplant
3
Non-hematologic events
Timeframe: Up to 2 years post stem cell transplant
4
Hematological events
Timeframe: after 30 days post stem cell transplant
5
BOS Score
Timeframe: at 1 year post lung transplant
6
T-cell Chimerism
Timeframe: at 12 months post stem cell transplant
7
Myeloid chimerism
Timeframe: at 12 months post stem cell transplant
8
Restoration of blood cell count (in absence of growth factors)
✕. Females who are pregnant or who are lactating.
✕. 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.