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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.


Phase 1/Phase 2
18 Years
55 Years
Open (Enrolling)
Both
Leukemia, Lymphoma

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Trial Information

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.


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.


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

Type of Study:

Interventional

Study Design:

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

Outcome Measure:

Neutrophil engraftment (ANC > 0,5 G/l)

Outcome Time Frame:

28 days

Safety Issue:

No

Principal Investigator

Tomasz Czerw, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

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

Authority:

Poland: Ethics Committee

Study ID:

IBT-COI-01

NCT ID:

NCT01728389

Start Date:

November 2012

Completion Date:

April 2014

Related Keywords:

  • Leukemia
  • Lymphoma
  • allogenic stem cell transplantation
  • peripheral blood stem cells
  • intrabone
  • intra-bone
  • leukemia
  • lymphoma
  • Leukemia
  • Lymphoma

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