Intra-bone Cord Blood Transplantation in Patients With Haematological Malignancies

Overview

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

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: N/A
    • Intervention Model: Single Group Assignment
    • Primary Purpose: Treatment
    • Masking: None (Open Label)
  • Study Primary Completion Date: November 2012

Interventions

  • Procedure: Intrabone Allogeneic Transplant
    • Unrelated single unit intrabone cord blood transplantation

Arms, Groups and Cohorts

  • Experimental: Treatment
    • Patients with high risk haematological malignancies

Clinical Trial Outcome Measures

Primary Measures

  • Time to neutrophil recovery
    • Time Frame: 28 days after transplantation

Secondary Measures

  • 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

Participating in This Clinical Trial

Inclusion Criteria

  • Advanced or High Risk Haematological Malignancies – Age 18-65 years – no suitable unrelated HLA-matched donors identified in a clinically useful time-frame – Informed consent Exclusion Criteria:

  • Active infectious disease at inclusion – HIV- positivity or active hepatitis infection – Impaired liver function (Bilirubin > upper normal limit; Transaminases > 3.0 x upper normal limit) at inclusion – Impaired renal function (Creatinine-clearance <60 ml/min; Serum Creatinine >1.5 x upper normal limit) at inclusion – Psychiatric diseases or conditions that might impair the ability to give informed consent

Gender Eligibility: All

Minimum Age: 18 Years

Maximum Age: 65 Years

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • Ospedale Santa Croce-Carle Cuneo
  • Provider of Information About this Clinical Study
    • Principal Investigator: Roberto Sorasio, MD – Ospedale Santa Croce-Carle Cuneo
  • Overall Official(s)
    • Daniele Mattei, MD, Principal Investigator, ASO S Croce e Carle
  • Overall Contact(s)
    • Roberto Sorasio, Head, MD, +390171642229, rsorasio@inwind.it

References

Frassoni F, Gualandi F, Podesta M, Raiola AM, Ibatici A, Piaggio G, Sessarego M, Sessarego N, Gobbi M, Sacchi N, Labopin M, Bacigalupo A. Direct intrabone transplant of unrelated cord-blood cells in acute leukaemia: a phase I/II study. Lancet Oncol. 2008 Sep;9(9):831-9. doi: 10.1016/S1470-2045(08)70180-3. Epub 2008 Aug 8.

Page KM, Zhang L, Mendizabal A, Wease S, Carter S, Gentry T, Balber AE, Kurtzberg J. Total colony-forming units are a strong, independent predictor of neutrophil and platelet engraftment after unrelated umbilical cord blood transplantation: a single-center analysis of 435 cord blood transplants. Biol Blood Marrow Transplant. 2011 Sep;17(9):1362-74. doi: 10.1016/j.bbmt.2011.01.011. Epub 2011 Jan 28.

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