Intrabone Transplantation of Allogenic Peripheral Blood Stem Cells in Patients With Myeloid and Lymphoid Malignancies.
Study Details
Study Description
Brief Summary
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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
Phase 1/Phase 2 |
Detailed Description
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.
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: Intrabone transplantation 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
Direct intrabone transplantation procedure of peripheral blood haematopoietic stem cells form HLA-matched sibling donors in patients with myeloid and lymphoid malignancies.
|
Outcome Measures
Primary Outcome Measures
- Neutrophil engraftment (ANC > 0,5 G/l) [28 days]
Secondary Outcome Measures
- 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]
Other Outcome Measures
- Relapse incidence [1 year]
- Overall survival [1 year]
- Disease-free survival [1 year]
- Graft-versus-host disease incidence [1 year]
Eligibility Criteria
Criteria
Inclusion Criteria:
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Age 18-55 years
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Diagnosis of leukaemia or lymphoma
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Indication for allogenic stem cell transplantation according to European Group for Blood and Marrow Transplantation guidelines
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HLA-matched sibling donor qualified for peripheral blood stem cell donation
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Performance status WHO 0-1
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Written informed consent
Exclusion Criteria:
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Organ dysfunction: elevated ALT, AST, bilirubin, AF; creatinine >1.5 upper normal limit; LVEF <45%
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Active infection
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Unstable diabetes
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Psychiatric diseases
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Obesity or anatomical obstacle for direct intrabone transplantation
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | MSC Memorial CAncer Center and Institute of Oncology | Gliwice | Poland | 44-101 |
Sponsors and Collaborators
- Maria Sklodowska-Curie National Research Institute of Oncology
Investigators
- Principal Investigator: Tomasz Czerw, MD, Maria Sklodowska-Curie Memorial Cancer Center and Institute of Oncology, Gliwice Branch, Gliwice, Poland
Study Documents (Full-Text)
None provided.More Information
Publications
- 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.
- Massollo M, Podestà M, Marini C, Morbelli S, Cassanelli C, Pinto V, Ubezio G, Curti G, Uccelli A, Frassoni F, Sambuceti G. Contact with the bone marrow microenvironment readdresses the fate of transplanted hematopoietic stem cells. Exp Hematol. 2010 Oct;38(10):968-77. doi: 10.1016/j.exphem.2010.06.003. Epub 2010 Jun 13.
- Okada M, Yoshihara S, Taniguchi K, Kaida K, Ikegame K, Kato R, Tamaki H, Inoue T, Soma T, Kai S, Kato S, Ogawa H. Intrabone marrow transplantation of unwashed cord blood using reduced-intensity conditioning treatment: a phase I study. Biol Blood Marrow Transplant. 2012 Apr;18(4):633-9. doi: 10.1016/j.bbmt.2011.08.010. Epub 2011 Aug 23.
- IBT-COI-01