Multi-Drug Desensitization Protocol for Heart Transplant Candidates

Part of paid clinical trials in Spokane, Washington.

Sponsor
Providence Health & Services
Study ID
NCT01556347
Phase
PHASE2
Status
Terminated

Conditions

  • Heart Transplantation

Eligibility Criteria

Sex
ALL
Age
18 Years - 67 Years
Healthy Volunteers
Not accepted

Interventions

Study Details

Background: Patients may develop antibodies (human leukocyte antigen \[HLA\] alloantibodies) to other human tissues via pregnancy, transfusions or previous transplantation, which limits the ability to find an acceptable donor heart for transplantation. Such patients are at high risk for antibody mediated rejection, graft failure, and acute rejection (i.e. death). For successful transplantation, patients must receive organs from donors who lack the HLA antigens that correspond to their alloantibody specificities. No successful desensitization strategy currently exists. Purpose: To determine if desensitization by deletion of immunologic memory with a multi-drug approach including anti-T and B cell therapies and anti-plasma cell therapy can effectively eliminate or significantly reduce alloantibody levels and permit highly sensitized patients to obtain a heart transplant. This therapy is anticipated to remove immunologic memory and will require re-immunization.

Key Dates

Start date
Jul 31, 2012
Status verified
Jun 2018
Primary completion
May 31, 2016
Completion
May 31, 2016

Study Design

Enrollment
2 participants (actual)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: Elimination of Immunologic Memory
    A single arm multi-drug regimen is used to delete immunologic memory in order to reduce or eliminate alloreactive anti-HLA antibodies in highly sensitized heart transplant candidates. The intervention includes a protocol of Thymoglobulin, Rituximab, plasmapheresis and Bortezomib.

Primary Outcome Measure

Percentage of Patients With a Reduction in CPRA to Less Than 20% [ Time Frame: 365 days ]

Locations (1)

FacilityCityStateZIPSite coordinators
Providence Sacred Heart Medical CenterSpokaneWashington99204-

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By research site
Providence Sacred Heart Medical Center· Spokane, WA

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