Sequential, Related Donor Partial Liver Transplantation Followed by Bone Marrow Transplantation f… (NCT02702960) | Clinical Trial Compass
WithdrawnPhase 2
Sequential, Related Donor Partial Liver Transplantation Followed by Bone Marrow Transplantation for Hepatocellular Carcinoma (HCC)
Stopped: This study was withdrawn due to lack of necessary resources from the liver transplant surgical group.
United States0Started 2016-03
Plain-language summary
This trial is a phase II, single arm, open-label, single center study to assess a reduced-intensity conditioning regimen, bone marrow transplantation and high dose PTCy in recipients of a partial liver allograft from a Human Leukocyte Antigen (HLA)-matched or -haploidentical living related donor in patients with HCC.
The primary objective of this trial is to characterize recurrence-free survival at 1 year following bone marrow transplantation among recipients of prior partial liver transplantation from the same donor.
Who can participate
Age range16 Years – 65 Years
SexALL
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Inclusion criteria
✓. Histologic diagnosis of liver-confined fibrolamellar or non-fibrolamellar HCC. Ineligible for curative resection or deceased donor liver transplantation by virtue of NOT meeting the Milan criteria or down-staging criteria:
✓. Single viable tumor ≤5 cm in size or ≤3 tumors each ≤3 cm in size based on CT or Magnetic resonance (MR) imaging
✓. Pretransplant alpha fetoprotein (AFP) level of ≤400.
✓. Available human leukocyte antigen (HLA)-matched or -haploidentical, living related donor who is willing to donate bone marrow and part of liver. The donor and recipient must be HLA identical for at least one allele (using high resolution DNA based typing) at the following genetic loci: HLA-A, HLA-B, HLA-C and HLA-DRB1. Fulfilment of this criterion shall be considered sufficient evidence that the donor and recipient share one HLA haplotype.
✓. Age 16 to 65 years.
✓. Normal estimated left ventricular ejection fraction ( \>30% ) and no history of ischemic heart disease requiring revascularization, unless cleared by a cardiologist (as per normal liver and bone marrow (BM) transplant eligibility requirements). Those with an ejection fraction between 30-40%, will require a cardiology consultation and clearance for transplantation.
✓. Forced expiratory volume (FEV1) and forced vital capacity (FVC) \> 40% of predicted at the screening visit.
What they're measuring
1
1 year disease-free survival (at 1 year after BMT)
Timeframe: 1 year
Trial details
NCT IDNCT02702960
SponsorSidney Kimmel Comprehensive Cancer Center at Johns Hopkins
✕. Extrahepatic disease at the time of enrollment.
✕. Macrovascular invasion by tumor as seen on imaging
✕. Anti-donor HLA antibody with a level that produces a positive test on flow cytometric crossmatch. \[Note: patients with a positive flow cytometric crossmatch may undergo desensitization and may become eligible, at the discretion of the protocol investigators, if desensitization decreases the antibody concentration to a level that produces a negative flow cytometric crossmatch.\]
✕. Ineligible for liver transplantation per institutional criteria (see Appendix 1)
✕. Women who are breastfeeding.
✕. History of positive HIV-1 or HIV-2 serologies or nucleic acid test.
✕. Active hepatitis B infection as documented by positive Hepatitis B assay
✕. Any active, severe local or systemic infection at the screening visit.