Ignite Creation Date:
2025-12-26 @ 1:17 PM
Ignite Modification Date:
2026-01-01 @ 6:40 AM
Study NCT ID:
NCT01053806
Status:
UNKNOWN
Last Update Posted:
2012-09-25
First Post:
2010-01-19
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Safety And Efficacy Of Azacitidine, and Lenalidomide In Higher Risk Myelodysplastic Syndrome
Sponsor:
Tel-Aviv Sourasky Medical Center
Organization:
Study Overview
Official Title:
A PHASE 2, SINGLE ARM STUDY TO DETERMINE THE SAFETY AND EFFICACY OF AZACITIDINE, AND LENALIDOMIDE IN HIGHER RISK MYELODYSPLASTIC SYNDROME
Status:
UNKNOWN
Status Verified Date:
2012-09
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:
ViLen 001
Brief Summary:
To evaluate the overall response rate of the combination of 5-azacitidine + Lenalidomide in high risk MDS patients (INT-2 and High risk defined by IPSS), and patients with low and int-1 who are considered to be at high risk due to unfavorable additional factors.
* To evaluate the safety of the combination of 5-azacitidine + Lenalidomide in high risk MDS patients.
* To evaluate the hematological improvement rate.
* To evaluate the cytogenetic response rate.
* To evaluate the Progression free survival (PFS).
* To assess Quality of life.
* To evaluate the safety of the combination of 5-azacitidine + Lenalidomide in high risk MDS patients.
* To evaluate the hematological improvement rate.
* To evaluate the cytogenetic response rate.
* To evaluate the Progression free survival (PFS).
* To assess Quality of life.
Detailed Description:
None
Study Oversight
Has Oversight DMC:
Is a FDA Regulated Drug?:
Is a FDA Regulated Device?:
Is an Unapproved Device?:
Is a PPSD?:
Is a US Export?:
Is an FDA AA801 Violation?: