Clinical Trial: Intra-bone Cord Blood Transplantation in Patients With Haematological Malignancies
Study Status: Active, not recruiting
Recruit Status: Unknown status
Study Type: Interventional
Official Title: Intra-bone Cord Blood Transplantation in Patients With Haematological Malignancies
Brief Summary: Cord blood (CB) from an unrelated donor is increasingly used an alternative source of hematopoietic stem cells for adults with hematologic malignancies who lack an HLA-matched donor. However, the utilization of single-unit CB for transplantation of adult patients has been impeded by the low number of nucleated cells available from individual CB units. Direct intrabone CB injection (IBCBi) has been recently investigated as a solution to cell dose problem in adults, with the aims of minimizing non-specific loss of progenitors. We set up a phase I-II study to assess the safety and efficacy of CB transplantation by IBCBi in adult patients with advanced or high-risk hematological malignancies
Detailed Summary:
Sponsor: Ospedale Santa Croce-Carle Cuneo
Current Primary Outcome: Time to neutrophil recovery [ Time Frame: 28 days after transplantation ]
Original Primary Outcome: Same as current
Current Secondary Outcome:
- Incidence of platelet engraftment [ Time Frame: 100 days after transplantation ]
- Acute graft versus host disease [ Time Frame: 100 days after transplantation ]
- Chronic Graft Versus Host Disease [ Time Frame: One year after transplantation ]
- Overall Survival [ Time Frame: One year after transplantation ]
Original Secondary Outcome: Same as current
Information By: Ospedale Santa Croce-Carle Cuneo
Dates:
Date Received: June 4, 2012
Date Started: November 2008
Date Completion: May 2013
Last Updated: June 5, 2012
Last Verified: June 2012
