Intra-bone Cord Blood Transplantation in Patients With Haematological Malignancies

Advanced Haematological Malignancies Clinical Trial

Official title:

Intra-bone Cord Blood Transplantation in Patients With Haematological Malignancies

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT01613066
• Other study ID #: Emato68
• Status: Recruiting
• Phase: Phase 1/Phase 2
• First received: June 4, 2012
• Last updated: June 5, 2012
• Start date: November 2008
• Est. completion date: May 2013

Study information

• Verified date: June 2012
• Source: Ospedale Santa Croce-Carle Cuneo
• Contact: Roberto Sorasio, Head, MD
• Phone: +390171642229
• Email: rsorasio[@]inwind.it
• Is FDA regulated: No
• Health authority: Italy: Ethics Committee
• Study type: Interventional

Clinical Trial 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

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 15
• Est. completion date: May 2013
• Est. primary completion date: November 2012
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 65 Years

Eligibility

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 Design

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Advanced Haematological Malignancies
• Hematologic Neoplasms
• High Risk Haematological Malignancies
• Neoplasms

Intervention

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

Locations

Country	Name	City	State
Italy	Azienda Ospedaliera S Croce e Carle	Cuneo

Sponsors (1)

Lead Sponsor	Collaborator
Ospedale Santa Croce-Carle Cuneo

Country where clinical trial is conducted

Italy, 

References & Publications (2)

Frassoni F, Gualandi F, Podestà 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. — View 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Time to neutrophil recovery		28 days after transplantation	No
Secondary	Incidence of platelet engraftment		100 days after transplantation	No
Secondary	Acute graft versus host disease		100 days after transplantation	No
Secondary	Chronic Graft Versus Host Disease		One year after transplantation	No
Secondary	Overall Survival		One year after transplantation	No