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

NCT ID: NCT01728389

Last Updated: 2013-07-24

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: PHASE1/PHASE2
• Total Enrollment: 10 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2012-11-30
• Study Completion Date: 2014-04-30

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.

Conditions

Leukemia; Lymphoma

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Intrabone transplantation

Direct intrabone transplantation procedure of peripheral blood haematopoietic stem cells form HLA-matched sibling donors in patients with myeloid and lymphoid malignancies.

Group Type: EXPERIMENTAL

Intrabone transplantation

Intervention Type: PROCEDURE

Direct intrabone transplantation procedure of peripheral blood haematopoietic stem cells form HLA-matched sibling donors in patients with myeloid and lymphoid malignancies.

Interventions

Intrabone transplantation

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

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 55 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Maria Sklodowska-Curie National Research Institute of Oncology

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Tomasz Czerw, MD

Role: PRINCIPAL_INVESTIGATOR

Maria Sklodowska-Curie Memorial Cancer Center and Institute of Oncology, Gliwice Branch, Gliwice, Poland

Locations

MSC Memorial CAncer Center and Institute of Oncology

Gliwice, , Poland

Site Status: RECRUITING

Countries

Poland

Central Contacts

Tomasz Czerw, MD

Role: CONTACT

tomcmed@poczta.onet.pl

+48 32 2788523

Sebastian Giebel, MD

Role: CONTACT

sgiebel@io.gliwice.pl

+48 32 2788523

Facility Contacts

Sebastian Giebel, Assoc. prof.

Role: primary

ots@io.gliwice.pl

+48322788523

References

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.

Reference Type: BACKGROUND

PMID: 18693069 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 21867667 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 20550953 (View on PubMed)

Other Identifiers

IBT-COI-01

Identifier Type: -

Identifier Source: org_study_id