Intrabone Transplantation of Allogenic Peripheral Blood Stem Cells in Patients With Myeloid and Lymphoid Malignancies.

Study Overview
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Brief Summary
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The purpose of the study is to evaluate efficacy and safety of direct intrabone transplantation procedure of peripheral blood haematopoietic stem cells form HLA-matched sibling donors in patients with myeloid and lymphoid malignancies.

Detailed Description
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Allogenic haematopoietic stem cell transplantation is an established treatment option for haematologic malignancies, especially leukaemias and lymphomas, providing curative potential. The optimal donor is HLA-matched sibling and G-CSF stimulated peripheral blood is nowadays the most common source of stem cells. Routinely used route of stem cell transplantation is intravenous infusion via central venous catheter. Based on the animal studies, only 10-15% of intravenously transplanted stem cells migrate to haematopoietic sites while the rest is lost in other organs. Results of studies of direct intrabone allogenic cord-blood cells transplantation in humans confirm that this route of transplantation is associated with less probability of graft failure and moreover may reduce risk of graft-versus-host disease and malignancy relapse. For those purposes in the current study we investigate intrabone route of allogenic peripheral blood stem cell transplantation. Our intention is to achieve fast engraftment and minimize risk of relapse and graft graft-versus-host disease.

Official Title
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Efficacy and Safety of Direct Intrabone Transplantation of Peripheral Blood Haematopoietic Stem Cells Form HLA-matched Sibling Donors in Patients With Myeloid and Lymphoid Malignancies.

Conditions
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Leukemia, Lymphoma

Intervention / Treatment
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* Procedure: Intrabone transplantation


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Age 18-55 years Diagnosis of leukaemia or lymphoma Indication for allogenic stem cell transplantation according to European Group for Blood and Marrow Transplantation guidelines HLA-matched sibling donor qualified for peripheral blood stem cell donation Performance status WHO 0-1 Written informed consent Exclusion Criteria: Organ dysfunction: elevated ALT, AST, bilirubin, AF; creatinine >1.5 upper normal limit; LVEF <45% Active infection Unstable diabetes Psychiatric diseases Obesity or anatomical obstacle for direct intrabone transplantation

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 55 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: Intrabone transplantation<br>Direct intrabone transplantation procedure of peripheral blood haematopoietic stem cells form HLA-matched sibling donors in patients with myeloid and lymphoid malignancies. | Procedure: Intrabone transplantation<br>* Direct intrabone transplantation procedure of peripheral blood haematopoietic stem cells form HLA-matched sibling donors in patients with myeloid and lymphoid malignancies.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Neutrophil engraftment (ANC > 0,5 G/l) |  | 28 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Lineage chimerism of peripheral blood T-cell lymphocytes |  | 1 year | 
| Platelet engraftment (Plt > 20 G/l) |  | 28 days | 
| Adverse reactions related with intrabone transplantation procedure |  | 28 days | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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peripheral blood stem cells, intra-bone, leukemia, lymphoma, allogenic stem cell transplantation, intrabone