Intra-bone Cord Blood Transplantation in Patients With Haematological Malignancies

Study Overview
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Brief Summary
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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

Official Title
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Intra-bone Cord Blood Transplantation in Patients With Haematological Malignancies

Conditions
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High Risk Haematological Malignancies, Advanced Haematological Malignancies

Intervention / Treatment
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* Procedure: Intrabone Allogeneic Transplant


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Treatment<br>Patients with high risk haematological malignancies | Procedure: Intrabone Allogeneic Transplant<br>* Unrelated single unit intrabone cord blood transplantation<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Time to neutrophil recovery |  | 28 days after transplantation | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Haematological malignancies, Allogeneic Cord Blood transplantation, Intrabone