Clinical trial NCT01613066: 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
Overall status: UNKNOWN
Phase: PHASE1
PHASE2
Conditions: High Risk Haematological Malignancies
Advanced Haematological Malignancies
Keywords: Haematological malignancies
Allogeneic Cord Blood transplantation
Intrabone
Lead sponsor: Ospedale Santa Croce-Carle Cuneo
Sponsor class: OTHER
First posted: 2012-06-06
Enrollment: 15
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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


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

Primary outcomes:
measure: Time to neutrophil recovery
timeFrame: 28 days after transplantation
Secondary outcomes:
measure: Incidence of platelet engraftment
timeFrame: 100 days after transplantation
measure: Acute graft versus host disease
timeFrame: 100 days after transplantation
measure: Chronic Graft Versus Host Disease
timeFrame: One year after transplantation
measure: Overall Survival
timeFrame: One year after transplantation
Other outcomes:
Locations:
city: Cuneo
country: Italy
facility: Azienda Ospedaliera S Croce e Carle
Study officials:
affiliation: ASO S Croce e Carle
name: Daniele Mattei, MD
role: PRINCIPAL_INVESTIGATOR
References:
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.
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.