Ignite Creation Date:
2024-05-05 @ 5:17 PM
Last Modification Date:
2024-10-26 @ 9:30 AM
Study NCT ID:
NCT00424229
Status:
UNKNOWN
Last Update Posted:
2007-03-12
First Post:
2007-01-15
Brief Title:
Lenalidomide in Subjects With intermediate2 or High MDS Associated With a Deletion DEL 5q 31
Sponsor:
Groupe Francophone des Myelodysplasies
Organization:
Groupe Francophone des Myelodysplasies
Study Overview
Official Title:
Phase II Study of the Efficacy and Safety of Lenalidomide in Adult Subjects With Intermediate-2-or Higt Risk Myelodysplastic SyndromeMDS Associated With a Deletion DEL 5q 31
Status:
UNKNOWN
Status Verified Date:
2007-01
Last Known Status:
RECRUITING
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
We are evaluating the incidence of significant hematological response according to IWG criteria including CR PR or major HI HI-E Hl-Nor Hl- P and cytogenetic response of patients diagnosed with intermediate-2 or high-risk International Prognostic Scoring System IPSS MDS with a deletion del 5q31
Detailed Description:
Subjects meeting all inclusion and exclusion criteria will receive lenalidomide
lenalidomide will be administered at 10 mg two 5 mg capsules once daily on Days 1-21 every 4 weeks
Bone marrow aspirate baseline and during the course of the study at week 8 16 32 52 and when clinically indicatedfor assessment of disease progression evaluations
Subjects may participate in the study for up to 52 weeks in patients still responding after 52 weeks the drug wil continue to be supplied
lenalidomide will be administered at 10 mg two 5 mg capsules once daily on Days 1-21 every 4 weeks
Bone marrow aspirate baseline and during the course of the study at week 8 16 32 52 and when clinically indicatedfor assessment of disease progression evaluations
Subjects may participate in the study for up to 52 weeks in patients still responding after 52 weeks the drug wil continue to be supplied
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None