Multi-Drug Desensitization Protocol for Heart Transplant Candidates

Summary

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.

Timeline

Start

2012-07

Primary completion

2016-05

Completion

2016-05

Outcome

Outcome not reported

Stopped: “Lack of efficacy”

Drugs

Indications

No indication recorded.