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

Phase 1

• Conditions: Leukemia; Lymphoma
• Interventions: Procedure: Intrabone transplantation

• Registration Number: NCT01728389
• Lead Sponsor: Maria Sklodowska-Curie National Research Institute of Oncology

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.

Study Timeline

• Study Start: 2012-11
• Study First Submitted: 2012-11-13
• Study First Submitted QC: 2012-11-13
• Study First Posted: 2012-11-19
• Status Verified: 2013-07
• Last Update Submitted: 2013-07-23
• Last Update Posted: 2013-07-24
• Primary Completion: 2013-12
• Study Completion: 2014-04

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 10

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

Read More

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

Read More

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

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

Primary Outcome Measures

Name	Time	Method
Neutrophil engraftment (ANC > 0,5 G/l)	28 days

Secondary Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (1)

MSC Memorial CAncer Center and Institute of Oncology; 🇵🇱 Gliwice, Poland