Intrabone Transplantation of Allogenic Peripheral Blood Stem Cells in Patients With Myeloid and Lymphoid Malignancies.
Primary Purpose
Leukemia, Lymphoma
Status
Unknown status
Phase
Phase 1
Locations
Poland
Study Type
Interventional
Intervention
Intrabone transplantation
Sponsored by
About this trial
This is an interventional treatment trial for Leukemia focused on measuring allogenic stem cell transplantation, peripheral blood stem cells, intrabone, intra-bone, leukemia, lymphoma
Eligibility Criteria
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
Sites / Locations
- MSC Memorial CAncer Center and Institute of OncologyRecruiting
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Intrabone transplantation
Arm Description
Direct intrabone transplantation procedure of peripheral blood haematopoietic stem cells form HLA-matched sibling donors in patients with myeloid and lymphoid malignancies.
Outcomes
Primary Outcome Measures
Neutrophil engraftment (ANC > 0,5 G/l)
Secondary Outcome Measures
Lineage chimerism of peripheral blood T-cell lymphocytes
Platelet engraftment (Plt > 20 G/l)
Adverse reactions related with intrabone transplantation procedure
Full Information
NCT ID
NCT01728389
First Posted
November 13, 2012
Last Updated
July 23, 2013
Sponsor
Maria Sklodowska-Curie National Research Institute of Oncology
1. Study Identification
Unique Protocol Identification Number
NCT01728389
Brief Title
Intrabone Transplantation of Allogenic Peripheral Blood Stem Cells in Patients With Myeloid and Lymphoid Malignancies.
Official Title
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.
Study Type
Interventional
2. Study Status
Record Verification Date
July 2013
Overall Recruitment Status
Unknown status
Study Start Date
November 2012 (undefined)
Primary Completion Date
December 2013 (Anticipated)
Study Completion Date
April 2014 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Maria Sklodowska-Curie National Research Institute of Oncology
4. Oversight
Data Monitoring Committee
Yes
5. 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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Leukemia, Lymphoma
Keywords
allogenic stem cell transplantation, peripheral blood stem cells, intrabone, intra-bone, leukemia, lymphoma
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 1, Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
10 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Intrabone transplantation
Arm Type
Experimental
Arm Description
Direct intrabone transplantation procedure of peripheral blood haematopoietic stem cells form HLA-matched sibling donors in patients with myeloid and lymphoid malignancies.
Intervention Type
Procedure
Intervention Name(s)
Intrabone transplantation
Intervention Description
Direct intrabone transplantation procedure of peripheral blood haematopoietic stem cells form HLA-matched sibling donors in patients with myeloid and lymphoid malignancies.
Primary Outcome Measure Information:
Title
Neutrophil engraftment (ANC > 0,5 G/l)
Time Frame
28 days
Secondary Outcome Measure Information:
Title
Lineage chimerism of peripheral blood T-cell lymphocytes
Time Frame
1 year
Title
Platelet engraftment (Plt > 20 G/l)
Time Frame
28 days
Title
Adverse reactions related with intrabone transplantation procedure
Time Frame
28 days
Other Pre-specified Outcome Measures:
Title
Relapse incidence
Time Frame
1 year
Title
Overall survival
Time Frame
1 year
Title
Disease-free survival
Time Frame
1 year
Title
Graft-versus-host disease incidence
Time Frame
1 year
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
55 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Tomasz Czerw, MD
Phone
+48 32 2788523
Email
tomcmed@poczta.onet.pl
First Name & Middle Initial & Last Name or Official Title & Degree
Sebastian Giebel, MD
Phone
+48 32 2788523
Email
sgiebel@io.gliwice.pl
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Tomasz Czerw, MD
Organizational Affiliation
Maria Sklodowska-Curie Memorial Cancer Center and Institute of Oncology, Gliwice Branch, Gliwice, Poland
Official's Role
Principal Investigator
Facility Information:
Facility Name
MSC Memorial CAncer Center and Institute of Oncology
City
Gliwice
ZIP/Postal Code
44-101
Country
Poland
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Sebastian Giebel, Assoc. prof.
Phone
+48322788523
Email
ots@io.gliwice.pl
12. IPD Sharing Statement
Citations:
PubMed Identifier
18693069
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.
Results Reference
background
PubMed Identifier
21867667
Citation
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.
Results Reference
background
PubMed Identifier
20550953
Citation
Massollo M, Podesta 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.
Results Reference
background
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Intrabone Transplantation of Allogenic Peripheral Blood Stem Cells in Patients With Myeloid and Lymphoid Malignancies.
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