Clinical Trials

1 studies in Hematological malignancies

1. A Multicenter Access and Distribution Protocol for Unlicensed Cryopreserved Cord Blood Units (CBUs) Jacksonville, FL Scottsdale and Phoenix, AZ Rochester, MN View Summary
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   A Multicenter Access and Distribution Protocol for Unlicensed Cryopreserved Cord Blood Units (CBUs)

   Location:

   Jacksonville, FL Scottsdale and Phoenix, AZ Rochester, MN

   Trial status:

   Open for Enrollment

   Why is this study being done?

   Principal Investigators: The principal investigators (PIs) will be transplant physicians at all participating U.S. transplant centers. Study Design: This study is an access and distribution protocol for unlicensed cryopreserved cord blood units (CBUs) in pediatric and adult patients with hematologic malignancies and other indications. Primary Objective: The primary aim of this study is to examine the incidence of neutrophil recovery of ≥500/mm3 after cord blood transplantation in a multi-institution setting using CBUs that are not Food and Drug Administration (FDA) licensed. Secondary Objectives: In patients receiving a non-licensed CBU: - Assess incidence of graft rejection - Assess incidence of transmission of infection - Assess incidence of serious infusion reaction - Determine 1 year survival after cord blood transplantation - Assess cumulative incidence of acute graft vs. host disease (GVHD) grades II to IV and grades III to IV - Assess cumulative incidence of chronic GVHD - Determine platelet engraftment of >20,000 mcL and >50,000 mcL - Determine CBU-derived engraftment

   NCT ID:

   NCT01351545

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   Who can I contact for additional information about this study?

   Rochester: William Hogan, MD
                       
   Scottsdale: James Slack, MD
                       
   Jacksonville: Vivek Roy, MD