Intra-bone Cord Blood Transplantation in Patients With Haematological Malignancies

NCT01613066 | Unknown Phase 1

• 1 other identifier: Emato68
• Study Type: interventional
• Target: 15
• Locations: 1 country
• Sites: 1

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

Conditions

High Risk Haematological Malignancies; Advanced Haematological Malignancies

Keywords

Haematological malignancies; Allogeneic Cord Blood transplantation; Intrabone

Outcome Measures

Primary Outcomes (1)

• Time to neutrophil recovery

  28 days after transplantation

Secondary Outcomes (4)

• Incidence of platelet engraftment

  100 days after transplantation

• Acute graft versus host disease

  100 days after transplantation

• Chronic Graft Versus Host Disease

  One year after transplantation

• Overall Survival

  One year after transplantation

Study Arms (1)

Treatment

EXPERIMENTAL

Patients with high risk haematological malignancies

Procedure: Intrabone Allogeneic Transplant

Interventions

Intrabone Allogeneic Transplant PROCEDURE

Unrelated single unit intrabone cord blood transplantation

Treatment

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• HIV- positivity or active hepatitis infection
• Psychiatric diseases or conditions that might impair the ability to give informed consent

Sponsors & Collaborators

• Ospedale Santa Croce-Carle Cuneo: lead

Study Sites (1)

Azienda Ospedaliera S Croce e Carle

Cuneo, Cuneo, 12100, Italy

RECRUITING

Related Publications (2)

• 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.

  PMID: 18693069 BACKGROUND

• 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.

  PMID: 21277377 BACKGROUND

Study Officials

• Daniele Mattei, MD

  ASO S Croce e Carle

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Roberto Sorasio, Head, MD

CONTACT

+390171642229; rsorasio@inwind.it

Daniele Mattei, MD

CONTACT

+390171642229; mattei.d@ospedale.cuneo.it

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD

Study Record Dates

• First Submitted: June 4, 2012
• First Posted: June 6, 2012
• Study Start: November 1, 2008
• Primary Completion: November 1, 2012
• Study Completion: May 1, 2013
• Last Updated: June 6, 2012

Record last verified: 2012-06

Locations

IT (1)