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

Lymphoma Clinical Trial

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.

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT01728389
• Other study ID #: IBT-COI-01
• Status: Recruiting
• Phase: Phase 1/Phase 2
• First received: November 13, 2012
• Last updated: July 23, 2013
• Start date: November 2012
• Est. completion date: April 2014

Study information

• Verified date: July 2013
• Source: Maria Sklodowska-Curie Memorial Cancer Center, Institute of Oncology
• Contact: Tomasz Czerw, MD
• Phone: +48 32 2788523
• Email: tomcmed[@]poczta.onet.pl
• Is FDA regulated: No
• Health authority: Poland: Ethics Committee
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 10
• Est. completion date: April 2014
• Est. primary completion date: December 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 55 Years

Eligibility

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

Study Design

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Leukemia
• Lymphoma

Intervention

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.

Locations

Country	Name	City	State
Poland	MSC Memorial CAncer Center and Institute of Oncology	Gliwice

Sponsors (1)

Lead Sponsor	Collaborator
Maria Sklodowska-Curie Memorial Cancer Center, Institute of Oncology

Country where clinical trial is conducted

Poland, 

References & Publications (3)

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. — View Citation

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. — View 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Relapse incidence		1 year	No
Other	Overall survival		1 year	No
Other	Disease-free survival		1 year	No
Other	Graft-versus-host disease incidence		1 year	No
Primary	Neutrophil engraftment (ANC > 0,5 G/l)		28 days	No
Secondary	Lineage chimerism of peripheral blood T-cell lymphocytes		1 year	No
Secondary	Platelet engraftment (Plt > 20 G/l)		28 days	No
Secondary	Adverse reactions related with intrabone transplantation procedure		28 days	Yes