Study population - patient age 18-65 years - eligible for an ASCT for lymphoma or MM - at least = 10 x 106 CD34+ cells/kg have been collected during the previous performed leucofereses procedure
Conditions
Interventions
Product Name: autologous stem cell transplant
Product Code: n.a.
Pharmaceutical Form: Concentrate and solvent for solution for injection
Sponsors
University Medical Center Groningen
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: - age 18-65 years - eligible for ASCT for lymphoma or MM - at least =10x106 CD34+ cells/kg have been collected during the previously performed leucophereses procedure Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range F.1.3 Elderly (>=65 years) no F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: - inadequate stem cell collection (<10x106 CD34+ cells/kg) - previous radiotherapy on pelvis - previous infections complications in the pelvis region
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To improve the regenerative capacity of the bone marrow compartment post-ASCT by infusing the autologous stem cell transplant directly in the bone marrow compartment instead of infusing the cells intravenously. ;Secondary Objective: a. Duration of short-term recovery (granulocytes = 0.1 x 109/l or = 0.5 x 109/l; platelets = 20 x 109/l without transfusion) and long-term recovery (normalisation all 3 lineages; number of transfusions); peripheral blood counts 6 months post-ASCT. b. Graft-failure. A graft failure is defined as an in-adequate granulocyte recovery (0.5x109/l) after 22 +/- 12 days (x +/- SD) and platelet recovery (>20x109/l) after 31 +/- 40 days. c. Infection of the pelvis. d. In-vitro phenotyping and functional characterisation of the stem cell compartment by using Facs and in-vitro culture assays 6-9 months post-transplantation in the case the peripheral blood cell counts have been normalised as defined above13. e. In-vivo imaging of the bone marrow compartment by means of FLT-PET14. This imaging technique provides the opportunity to image the total bone marrow compartment and to quantify the uptake by calculating standardized uptake value (SUV) values. | — |
Countries
Netherlands
Outcome results
None listed