Advanced Haematological Malignancies, High Risk Haematological Malignancies
Conditions
Keywords
Haematological malignancies, Allogeneic Cord Blood transplantation, Intrabone
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
Interventions
PROCEDUREIntrabone Allogeneic Transplant
Unrelated single unit intrabone cord blood transplantation
Sponsors
Ospedale Santa Croce-Carle Cuneo
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Time to neutrophil recovery | 28 days after transplantation |
Secondary
| Measure | Time frame |
|---|---|
| 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 |
Countries
Italy
Contacts
Primary ContactRoberto Sorasio, Head, MD
Backup ContactDaniele Mattei, MD
Outcome results
None listed