Intra-bone Cord Blood Transplantation in Patients With Haematological Malignancies

June 5, 2012 updated by: Roberto Sorasio, Ospedale Santa Croce-Carle Cuneo
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 Overview

Status

Unknown

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

15

Phase

  • Phase 2
  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • Italy
      • Cuneo, Italy, 12100
        • Recruiting
        • Azienda Ospedaliera S Croce e Carle
        • Contact:
        • Contact:
        • Principal Investigator:
          • Daniele Mattei, MD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 65 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Treatment
Patients with high risk haematological malignancies
Procedure: Intrabone Allogeneic Transplant
Unrelated single unit intrabone cord blood transplantation

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Time to neutrophil recovery
Time Frame: 28 days after transplantation
28 days after transplantation

Secondary Outcome Measures

Outcome Measure
Time Frame
Incidence of platelet engraftment
Time Frame: 100 days after transplantation
100 days after transplantation
Acute graft versus host disease
Time Frame: 100 days after transplantation
100 days after transplantation
Chronic Graft Versus Host Disease
Time Frame: One year after transplantation
One year after transplantation
Overall Survival
Time Frame: One year after transplantation
One year after transplantation

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Ospedale Santa Croce-Carle Cuneo

Investigators

  • Principal Investigator: Daniele Mattei, MD, ASO S Croce e Carle

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

November 1, 2008

Primary Completion (Anticipated)

November 1, 2012

Study Completion (Anticipated)

May 1, 2013

Study Registration Dates

First Submitted

June 4, 2012

First Submitted That Met QC Criteria

June 5, 2012

First Posted (Estimate)

June 6, 2012

Study Record Updates

Last Update Posted (Estimate)

June 6, 2012

Last Update Submitted That Met QC Criteria

June 5, 2012

Last Verified

June 1, 2012

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Emato68

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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