Ignite Creation Date:
2025-12-24 @ 2:58 PM
Ignite Modification Date:
2025-12-30 @ 3:13 AM
Study NCT ID:
NCT00839059
Status:
TERMINATED
Last Update Posted:
2011-07-29
First Post:
2009-01-20
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Lenalidomide In Patients With Acute Myeloid Leukemia
Sponsor:
University of Ulm
Organization:
Study Overview
Official Title:
Open-Label, Multi-Center Phase I Dose-Escalation Study With Lenalidomide In Patients With Acute Myeloid Leukemia
Status:
TERMINATED
Status Verified Date:
2011-07
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Results of an interim analysis and a hardly ongoing enrolment in the last 10 months in all six participating centres
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
This is a Phase I, open-label, multi-center, dose-escalation study of lenalidomide in adult patients with newly diagnosed, relapsed or refractory acute myeloid leukemia. All patients will receive lenalidomide per oral daily (starting dose is 25 mg/d). Cohorts of 3 patients (to be expanded up to 6 if 1 dose-limiting toxicity (DLT) is observed among the first 3 patients) will be sequentially allotted to progressively higher dose levels of lenalidomide on the basis of the presence and severity of lenalidomide-related toxicity or lenalidomide related serious adverse reactions encountered in the first cycle. For the purpose of this study, patients' enrollment will continue until the maximum tolerated dose (MTD) will be determined and characterized.
Detailed Description:
None
Study Oversight
Has Oversight DMC:
True
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?: