drugset / Trial / NCT02702960
Sequential, Related Donor Partial Liver Transplantation Followed by Bone Marrow Transplantation for Hepatocellular Carcinoma (HCC)
Phase 2
Withdrawn
Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
Fibrolamellar Cancer Foundation · collab
NaSingle-groupOpen-labelTreatment
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.
Timeline
- Start
- 2016-03
- Primary completion
- 2018-01-03
- Completion
- 2018-01-03
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Background | 2-MERCAPTOETHANESULFONIC ACID | Small molecule | — | — |
| Background | ANTILYMPHOCYTE IMMUNOGLOBULIN (HORSE) | Protein / enzyme biologic | — | — |
| Background | Cyclophosphamide | Other / unclassified | 50 mg/kg | — |
| Background | Fludarabine | Small molecule | — | — |
| Background | Mycophenolate Mofetil | Small molecule | — | — |
| Background | Prednisone | Other / unclassified | — | — |
| Background | Tacrolimus | Small molecule | — | — |
| Background | filgrastim | Protein / enzyme biologic | — | — |