Liver Transplantation Clinical Trial
Official title:
A Phase II Multicenter Trial to Assess the Safety and Efficacy of Campath-1H and Tacrolimus Followed By Immunosuppression Withdrawal in Liver Transplantation (ITN024ST)
Alemtuzumab is a man-made antibody used to treat certain blood disorders. Tacrolimus is a drug used to decrease immune system activity in people who have received organ transplants so that the new organ will not be rejected. This study will determine whether treatment with alemtuzumab and tacrolimus is effective in preventing organ rejection and maintaining the recipient's health after liver transplantation in patients with end-stage liver disease, and whether gradual tapering of tacrolimus treatment is safe for these patients.
Organ transplantation is a common procedure in hospitals, but organ rejection and serious
side effects are potential problems for the patient. Alemtuzumab is a monoclonal antibody
that binds to and depletes excess T cells in the bone marrow of leukemia patients. In this
study, alemtuzumab will destroy the recipient's white blood cells (WBCs) at the time of
transplantation. It is hoped that WBCs produced after alemtuzumab administration will
recognize the transplanted liver as "self" and not reject the new liver.
Drugs that suppress the immune system, such as tacrolimus, have contributed to increased
success of transplantation. However, to prevent organ rejection, transplant recipients need
to take immunosuppressive drugs for the rest of their lives, and these drugs make patients
more susceptible to infection, endangering their health and survival. Regimens that are less
toxic to or can eventually be withdrawn from transplant recipients are needed. This study
will evaluate the effects of two in-patient doses of alemtuzumab followed by maintenance
antirejection medication given to liver transplant patients post-transplant. This study will
also determine if post-transplant tacrolimus therapy can be slowly and safely tapered off
and withdrawn a year after transplant. Participants in this study will be patients with
end-stage liver disease who will undergo liver transplantation at the start of the study.
This study will last at least 2 years. Patients will undergo liver transplantation at the
start of the study on Day 0. Patients will receive in-patient infusions of alemtuzumab on
Days 0 and 4. Starting on Day 1, patients will receive oral cyclosporine, mycophenolate
mofetil, and/or tacrolimus daily. Patients will be hospitalized for at least 1 week after
transplantation. Because of suppression of patients' immune systems by alemtuzumab and these
other immunosuppressants, they will also receive prophylactic medications for a minimum of 3
months after transplantation to prevent opportunistic infections.
There will be at least eight study visits; they will occur at Days 4, 7, and 14 and at
Months 1, 3, 6, 9, and 12. Patients will have liver biopsies at Day 0 and Months 6 and 12.
At Month 12, participants will have assessments and blood tests to determine if they meet
certain criteria and are eligible to undergo tacrolimus tapering. Patients eligible for
tapering will undergo a 12-month gradual withdrawal of tacrolimus; they will be followed for
an additional 2 years, with study visits at Months 18, 24, 30, and 36. Patients ineligible
for tacrolimus tapering will continue taking their antirejection medication for the duration
of the study; they will be followed for an additional year, with study visits at Months 18
and 24.
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Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
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