As of 11-30-98, thirteen patients had been entered onto the study. No evidence of graft-vs-host disease has been detected in any patient, but infusions have been discontinued in 7 patients before the complete course of 4 were administered. One patient had an acute allergic-like reaction with transient hives and nausea. This resolved spontaneously. One patient with an EBV+ T-cell lymphoma developed progressive disease and was removed from the study after the third CTL infusion to be placed in hospice care. Two other patients developed worsening neutropenia. In both instances, a progressive decline in neutrophils preceded T cell infusions and therefore the infusions were not thought to be related to the decline. However, because neutropenia is a possible manifestation of transfusion related graft-vs-host disease, infusions were stopped. One patient developed an alveolitis in a transplanted lung following two infusions. Transbronchial biopsy showed no evidence of rejection or graft-vs-host disease (and did not identify an infectious etiology). However, since no etiology was established, T-cell infusions were stopped. One patient post-liver transplant developed an elevation of liver function tests (LFTs) prior to completion of 4 infusions. Because this elevation was a possible manifestation of rejection, infusions were stopped. The patients's LFTs returned to baseline within 14 days. During the course of the patient's CTL infusions, a persistent fibrin sheath had been identified in the patient's central access catheter which required repeated intensive thrombolytic therapy. This may have contributed to the LFT elevation. One patient with HIV-lymphoma developed progressive disease and was removed from the study after the third CTL infusion to be placed in hospice care.
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