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

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.

Status

UNKNOWN

Phases

Phase 1Phase 2

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01728389

Enrollment

Registered

2012-11-19

Start date

2012-11-30

Completion date

2014-04-30

Last updated

2013-07-24

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Leukemia, Lymphoma

Keywords

allogenic stem cell transplantation, peripheral blood stem cells, intrabone, intra-bone, leukemia, lymphoma

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.

Interventions

PROCEDUREIntrabone transplantation

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

Study design

Allocation

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to 55 Years

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame
Neutrophil engraftment (ANC > 0,5 G/l)	28 days

Secondary

Measure	Time frame
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

Measure	Time frame
Relapse incidence	1 year
Overall survival	1 year
Disease-free survival	1 year
Graft-versus-host disease incidence	1 year

Countries

Poland

Contacts

Primary ContactTomasz Czerw, MD

tomcmed@poczta.onet.pl+48 32 2788523

Backup ContactSebastian Giebel, MD

sgiebel@io.gliwice.pl+48 32 2788523

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026