A Pilot Study of the Combination of Lenalidomide (Revlimid®) With Two Different Dose Levels of Short Term Administration of Recombinant Human Stem Cell Factor (rhSCF; Ancestim) for Myelodysplasia.
Sponsor study identifier
interventional
25
1 country
1
Study Start
February 2007
Date type not reportedThis date has not been verified as actual or estimated.
Primary Completion
May 2011
Actual (reported)Study Completion
May 2014
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
This study is mainly assessing the safety of Revlimid in combination with Ancestim (recombinant human stem cell factor) in patients with symptomatic myelodysplasia. Of those two compounds, Revlimid has been shown to be an active drug in myelodysplasia. Clinical responses will also be assessed.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
May 2014
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
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Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
February 2007
Date type not reportedThis date has not been verified as actual or estimated.
February 11, 2007
Actual (reported)February 13, 2007
Actual (reported)May 2011
Actual (reported)May 2014
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Toxicity as defined by NCI-CTCv3.0
3 years
Response
3 years
Pharmacodynamics
defined in protocol
Change in Biomarkers
defined in protocol
Drug: Lenalidomide + Ancestim Dose level 1. Lenalidomide 10mg orally daily days 1-21/ 28 day cycle Ancestim 10mc/kg subcutaneously daily for 7 days for cycle 3 only 10mg orally daily days 1-21/ 28 day cycle. Dose level 2 Ancestim 20mc/kg subcutaneously daily for 7 days for cycle 3 only 10mg orally daily days 1-21/ 28 day cycle
Dose level 1. Lenalidomide 10mg orally daily days 1-21/ 28 day cycle Ancestim 10mc/kg subcutaneously daily for 7 days for cycle 3 only 10mg orally daily days 1-21/ 28 day cycle. Dose level 2 Ancestim 20mc/kg subcutaneously daily for 7 days for cycle 3 only 10mg orally daily days 1-21/ 28 day cycle
These entries preserve how the registry describes the intervention. Their treatment roles are shown separately from molecular identities.
Partially structured registry wording
Lenalidomide + Ancestim
Part of this registry label remains unresolved and is preserved as written. Recognized names are text references, not confirmed ingredients. Composition, doses and actual exposure are not established.
Names joined in the label
1 recognized name reference in the wording; 1 unresolved part.
Peter MacCallum Cancer Centre
East Melbourne, Victoria, 3002, Australia
Miles Prince, Prof.
Peter MacCallum Cancer Centre, Australia
25 participants (actual enrollment reported by the registry).
First Submitted
February 11, 2007
First Posted
February 13, 2007
Study Start
February 2007
Date type not reportedThis date has not been verified as actual or estimated.
Contact the study team to confirm eligibility.
Primary Completion
May 2011
Actual (reported)Study Completion
May 2014
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Last Updated
January 10, 2013
Record last verified: 2013-01
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Source: ClinicalTrials.gov.
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