Study on the impact of stem cell donation either after mobilisation with granulocyte colony stimulating factor (GCSF) or bone marrow harvest on unrelated donors. MedDRA version: 14.1 Level: PT Classification code 10051716 Term: Peripheral blood stem cell apheresis System Organ Class: 10042613 - Surgical and medical procedures
Conditions
Interventions
Trade Name: GRANOCYTE
Pharmaceutical Form: Powder and solvent for solution for injection
INN or Proposed INN: LENOGRASTIM
CAS Number: 135968-09-1
Concentration unit: µg/kg microgram(s)/kilogram
Concen
Sponsors
University College London, Joint Research Office
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Pre-existing healthy volunteer unrelated donors (who have met strict and extensive entry criteria) on the Anthony Nolan and British Bone Marrow Registries. Aged 18-60 years. Minimum weight 51 Kgs. Participants in the prospective arm are able to undergo peripheral blood collection (apheresis) 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 150 F.1.3 Elderly (>=65 years) no F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: Pregnant or breastfeeding female. Family history of haematological malignance. Any related donor. Previously donated bone marrow or PBSC's Hypersensitive to Lenograstim (or its excipients; arginine, phenlanine, methionine, mannitol (E421) or polysorbate 20). Weight under 51 Kgs.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: The aim of this study is two fold a) Detection of any genetic differences between bone marrow and PBSC unrelated donors, 3-5 years post donation and confirm or refute the observations of “long-term genetic or epigenetic effects” published by Nagler et al. (completed – none detected see below) b) Screen and compare PBSC donors lymphocytes pre and up to 6 months post G-CSF exposure to detect any ‘short-term’ genetic changes also described by Nagler et al. The employment of more sensitive methods such as iFISH and gene array analysis to assess any permanent genetic changes, our primary objective, will make our study more robust. ;Secondary Objective: NONE;Primary end point(s): The binary variable genetic change i.e. clonal aberrations detected in any one of chromosomes 7, 8 and 17. ;Timepoint(s) of evaluation of this end point: There will be two arms: iii) Retrospective arm – time points 3 to 5 years post donation. (completed) iv) Prospective arm - Peripheral blood of 50 unrelated PBSC donors only will be examined at the following time points: prior to donation and before exposure to G-CSF (minus 2-3 wks); at donation and after exposure to G-CSF at Day 0 (on the day of Apheresis) and Day 90 +/- 14 days and Day 180 +/- 14 days post-donation. | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): none;Timepoint(s) of evaluation of this end point: none | — |
Countries
United Kingdom
Contacts
Public ContactGCSF Clinical Trials Information
University College London
Outcome results
None listed