Sequential, Related Donor Partial Liver Transplantation Followed by Bone Marrow Transplantation for Hepatocellular Carcinoma (HCC)

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.

Conditions

• Fibrolamellar Hepatocellular Carcinoma
• Hepatocellular Carcinoma (Fibrolamellar Variant)
• Hepatocellular Carcinoma

Interventions

PROCEDURE

living related donor partial liver transplantation

HLA matched or haploidentical related living donor partial liver transplant followed by tacrolimus, prednisone, and MMF immunosuppression for \>3 wks

RADIATION

Total body irradiation

200 cGy total body irradiation (TBI) on Day -1.

PROCEDURE

Bone marrow transplant from same donor

BMT using cells from the same Human Leukocyte Antigen (HLA)-matched or -haploidentical living related donor will be performed on Day 0

DRUG

Cyclophosphamide

Pre-transplantation low dose cyclophosphamide given day -6 and -5 Post-transplantation high dose cyclophosphamide (PTCy; 50 mg/kg/day) will be administered on Days 3 and 4 with hydration

DRUG

Mesna

administered on Days 3 and 4 with PTCy

DRUG

Filgrastim

administered daily starting on Day 5 until absolute neutrophil count (ANC) recovery

DRUG

Tacrolimus

Given after liver transplant for through day -7, stopped on day -6 and restarted on day 5 post BMT

DRUG

mycophenolate mofetil

Given after liver transplant for through day -7, stopped on day -6 and restarted on day 5 post BMT

DRUG

Prednisone

Given after liver transplant for through day -7, stopped on day -6 and restarted on day 5 post BMT

DRUG

Antithymocyte globulin

Given from Day -16 to Day -14 prior to bone marrow transplantation on day 0

DRUG

fludarabine

fludarabine given from Days -6 to Day -2 before BMT

Sponsors & Collaborators

• Fibrolamellar Cancer Foundation

  collaborator OTHER

• Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins

  lead OTHER

Study Design

Allocation

NA

Purpose

TREATMENT

Masking

NONE

Model

SINGLE_GROUP

Eligibility

Min Age

16 Years

Max Age

65 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2016-03-31

Primary Completion

2018-01-03

Completion

2018-01-03

Countries

• United States

Study Locations