A Phase 1/2 interventional study of VTP195183 in Multiple Myeloma and Lymphoma, sponsored by Peter MacCallum Cancer Centre, Australia. Completed at 1 site in Australia. Open to participants aged 18 Years to 70 Years. Per ClinicalTrials.gov, last updated 2012-05-10.
Sponsored by Peter MacCallum Cancer Centre, Australia · Phase 1/2, Interventional, and Treatment
Hematopoietic stem cells (HSC) are used to support the administration of high dose chemotherapy for a range of human cancers. For a safe HSC transplantation, a minimum of 5 million HSC per kilogram are required. HSC are collected from the bone marrow by using drugs such as G-CSF (filgrastim) which 'mobilize' them from the bone marrow into the bloodstream. HSC are collected from the bloodstream using an apheresis machine. Between 5 and 60% of patients fail to mobilize the minimum HSC dose required for safe transplantation, and this trial is investigating a way to enhance mobilization to overcome this problem. This trial aims to determine if a new vitamin A derivative is capable of enhancing HSC mobilization when used in conjunction with G-CSF. Patients will undergo two mobilization procedures. They will be given G-CSF alone, or a combination of the study drug plus G-CSF, and their stem cells will be collected. A comparison group of patients will be given G-CSF alone for both mobilizations. Stem cells collected from patients in this trial will be frozen and stored until they are required for transplantation into that patient. At that time, patients will be monitored for how well they recover from their high dose chemotherapy and HSC transplantation.
5,578 studies on the registry are indexed under Lymphoma; 825 are open to participants now.
This study's enrollment of 30 is below the median of 40 across 4,508 interventional studies indexed under Lymphoma.
Browse Lymphoma studies →Peter MacCallum Cancer Centre, Australia is the lead sponsor of 80 studies on the registry; 26 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
VTP195183: 60mg/m2 orally daily G-CSF: 10mcg/kg/day subcutaneously Provision is made for dose reduction of VTP195183 in the event of unexpected dose-limiting toxicities G-CSF10mcg/kg/day will commence on day 1 and will continue until the peripheral blood (PB) CD34+ count falls below baseline, or below 5 x 106/L, whichever happens first. Patients will be treated with VTP195183 alone at 60mg/m2/day from day 1 to day 7. On day 8 VTP195183 will be continued and G-CSF10mcg/kg/day will be added. VTP195183 plus G-CSF will continue until the peripheral blood (PB) CD34+ count falls below baseline, or below 5 x 106/L, whichever happens first.
PB CD34+ kinetics using VTP195183 plus G-CSF
Time frame: up to 28 days post study drug administration
The toxicity of VTP195183 pretreatment when used with G-CSF
Time frame: within 28 days of study drug administration
This study is completed, as verified in May 2012. You cannot join it, but the record below documents what was studied.
Get an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.
Peter MacCallum Cancer Centre, Australia