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Intra-bone Cord Blood Transplantation in Patients With Haematological Malignancies

This study is currently recruiting participants.
Verified June 2012 by Ospedale Santa Croce-Carle Cuneo
Sponsor:
Information provided by (Responsible Party):
Roberto Sorasio, Ospedale Santa Croce-Carle Cuneo
ClinicalTrials.gov Identifier:
NCT01613066
First received: June 4, 2012
Last updated: June 5, 2012
Last verified: June 2012
History of Changes
  Purpose

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


Condition Intervention Phase
High Risk Haematological Malignancies
Advanced Haematological Malignancies
 Procedure: Intrabone Allogeneic Transplant
 Phase 1
Phase 2

Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Intra-bone Cord Blood Transplantation in Patients With Haematological Malignancies

Resource links provided by NLM:

MedlinePlus related topics: Cancer
U.S. FDA Resources

Further study details as provided by Ospedale Santa Croce-Carle Cuneo:

Primary Outcome Measures:
  • Time to neutrophil recovery [ Time Frame: 28 days after transplantation ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Incidence of platelet engraftment [ Time Frame: 100 days after transplantation ] [ Designated as safety issue: No ]
  • Acute graft versus host disease [ Time Frame: 100 days after transplantation ] [ Designated as safety issue: No ]
  • Chronic Graft Versus Host Disease [ Time Frame: One year after transplantation ] [ Designated as safety issue: No ]
  • Overall Survival [ Time Frame: One year after transplantation ] [ Designated as safety issue: No ]

Estimated Enrollment: 15
Study Start Date: November 2008
Estimated Study Completion Date: May 2013
Estimated Primary Completion Date: November 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Treatment
Patients with high risk haematological malignancies
 Procedure: Intrabone Allogeneic Transplant
Unrelated single unit intrabone cord blood transplantation

  Eligibility

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01613066

Contacts
Contact: Roberto Sorasio, Head, MD +390171642229 rsorasio@inwind.it
Contact: Daniele Mattei, MD +390171642229 mattei.d@ospedale.cuneo.it

Locations
Italy
Azienda Ospedaliera S Croce e Carle Recruiting
Cuneo, Italy, 12100
Contact: Daniele Mattei, MD     +390171642229     mattei.d@ospedale.cuneo.it    
Contact: Roberto Sorasio, MD     +390171642229     rsorasio@inwind.it    
Principal Investigator: Daniele Mattei, MD            
Sponsors and Collaborators
Ospedale Santa Croce-Carle Cuneo
Investigators
Principal Investigator: Daniele Mattei, MD ASO S Croce e Carle
  More Information

Publications:

Responsible Party: Roberto Sorasio, MD, Ospedale Santa Croce-Carle Cuneo
ClinicalTrials.gov Identifier: NCT01613066     History of Changes
Other Study ID Numbers: Emato68
Study First Received: June 4, 2012
Last Updated: June 5, 2012
Health Authority: Italy: Ethics Committee

Keywords provided by Ospedale Santa Croce-Carle Cuneo:
Haematological malignancies
Allogeneic Cord Blood transplantation
Intrabone

Additional relevant MeSH terms:
Neoplasms
Hematologic Neoplasms
Neoplasms by Site
Hematologic Diseases

ClinicalTrials.gov processed this record on May 19, 2013