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Intra-bone Cord Blood Transplantation in Patients With Haematological Malignancies

Primary Purpose

High Risk Haematological Malignancies, Advanced Haematological Malignancies

Status

Unknown status

Phase

Phase 1

Locations

Italy

Study Type

Interventional

Intervention

Intrabone Allogeneic Transplant

About this trial

This is an interventional treatment trial for High Risk Haematological Malignancies focused on measuring Haematological malignancies, Allogeneic Cord Blood transplantation, Intrabone

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

Azienda Ospedaliera S Croce e CarleRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Treatment

Arm Description

Patients with high risk haematological malignancies

Outcomes

Primary Outcome Measures

Time to neutrophil recovery

Secondary Outcome Measures

Incidence of platelet engraftment

Acute graft versus host disease

Chronic Graft Versus Host Disease

Overall Survival

Full Information

NCT ID

NCT01613066

First Posted

June 4, 2012

Last Updated

June 5, 2012

Sponsor

Ospedale Santa Croce-Carle Cuneo

1. Study Identification

Unique Protocol Identification Number

NCT01613066

Brief Title

Intra-bone Cord Blood Transplantation in Patients With Haematological Malignancies

Official Title

Intra-bone Cord Blood Transplantation in Patients With Haematological Malignancies

Study Type

Interventional

2. Study Status

Record Verification Date

June 2012

Overall Recruitment Status

Unknown status

Study Start Date

November 2008 (undefined)

Primary Completion Date

November 2012 (Anticipated)

Study Completion Date

May 2013 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Ospedale Santa Croce-Carle Cuneo

4. Oversight

Data Monitoring Committee

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

High Risk Haematological Malignancies, Advanced Haematological Malignancies

Keywords

Haematological malignancies, Allogeneic Cord Blood transplantation, Intrabone

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 1, Phase 2

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

N/A

Enrollment

15 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Treatment

Arm Type

Experimental

Arm Description

Patients with high risk haematological malignancies

Intervention Type

Procedure

Intervention Name(s)

Intrabone Allogeneic Transplant

Intervention Description

Unrelated single unit intrabone cord blood transplantation

Primary Outcome Measure Information:

Title

Time to neutrophil recovery

Time Frame

28 days after transplantation

Secondary Outcome Measure Information:

Title

Incidence of platelet engraftment

Time Frame

100 days after transplantation

Title

Acute graft versus host disease

Time Frame

100 days after transplantation

Title

Chronic Graft Versus Host Disease

Time Frame

One year after transplantation

Title

Overall Survival

Time Frame

One year after transplantation

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

65 Years

Accepts Healthy Volunteers

Eligibility 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

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Roberto Sorasio, Head, MD

Phone

+390171642229

rsorasio@inwind.it

First Name & Middle Initial & Last Name or Official Title & Degree

Daniele Mattei, MD

Phone

+390171642229

mattei.d@ospedale.cuneo.it

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Daniele Mattei, MD

Organizational Affiliation

ASO S Croce e Carle

Official's Role

Principal Investigator

Facility Information:

Facility Name

Azienda Ospedaliera S Croce e Carle

City

Cuneo

ZIP/Postal Code

12100

Country

Italy

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Daniele Mattei, MD

Phone

+390171642229

mattei.d@ospedale.cuneo.it

First Name & Middle Initial & Last Name & Degree

Roberto Sorasio, MD

Phone

+390171642229

rsorasio@inwind.it

First Name & Middle Initial & Last Name & Degree

Daniele Mattei, MD

12. IPD Sharing Statement

Citations:

PubMed Identifier

18693069

Citation

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.

Results Reference

background

PubMed Identifier

21277377

Citation

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.

Results Reference

background

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Intra-bone Cord Blood Transplantation in Patients With Haematological Malignancies

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