Ignite Creation Date:
2024-05-05 @ 4:57 PM
Last Modification Date:
2024-10-26 @ 9:26 AM
Study NCT ID:
NCT00352001
Status:
COMPLETED
Last Update Posted:
2018-09-19
First Post:
2006-07-13
Brief Title:
Lenalidomide and Azacitidine in Treating Patients With Advanced Myelodysplastic Syndromes
Sponsor:
Mikkael Sekeres MD
Organization:
Case Comprehensive Cancer Center
Study Overview
Official Title:
A Phase III Study of Revlimid Lenalidomide in Combination With Vidaza Azacitidine in Patients With Advanced Myelodysplastic Syndrome MDS
Status:
COMPLETED
Status Verified Date:
2018-09
Last Known Status:
None
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:
RATIONALE Lenalidomide may stop the growth of cancer cells by blocking blood flow to the cancer Lenalidomide may also stimulate the immune system in different ways and stop cancer cells from growing Drugs used in chemotherapy such as azacitidine work in different ways to stop the growth of cancer cells either by killing the cells or by stopping them from dividing Azacitidine may also cause cancer cells to look more like normal cells and to grow and spread more slowly Giving lenalidomide together with azacitidine may kill more cancer cells
PURPOSE This phase I trial is studying the side effects and best dose of lenalidomide and azacitidine in treating patients with advanced myelodysplastic syndromes
PURPOSE This phase I trial is studying the side effects and best dose of lenalidomide and azacitidine in treating patients with advanced myelodysplastic syndromes
Detailed Description:
OBJECTIVES
Primary
Determine the maximum tolerated dose and dose-limiting toxicity of lenalidomide and azacitidine in patients with advanced myelodysplastic syndromes MDS
Secondary
Review clinical outcomes as defined by the International Working Group criteria in patients treated with this regimen
Determine time to transformation to acute myeloid leukemia or death in patients treated with this regimen
Determine time to relapse after achieving complete or partial remission in patients treated with this regimen
Determine time to disease progression in patients treated with this regimen
Determine the effect of this regimen on hematologic status including peripheral blood counts and the need for platelet andor red blood cell transfusions in these patients
OUTLINE This is an open-label multicenter dose-escalation study
Patients receive oral lenalidomide once daily on days 1-14 or days 1-21 and azacitidine subcutaneously once daily on days 1-5 or days 1-5 and 8-12 Treatment repeats every 28 days for up to 7 courses in the absence of relapse after achieving complete or partial remission disease progression or unacceptable toxicity
Cohorts of 3-6 patients receive escalating doses andor increasing dosing frequencies of lenalidomide and azacitidine until the maximum tolerated dose MTD is determined or the sixth dose level is reached whichever occurs first The MTD is defined as the dose preceding that at which 2 of 3 or 2 of 6 patients experience dose-limiting toxicity during the first course of therapy
After completion of study treatment patients are followed annually
Primary
Determine the maximum tolerated dose and dose-limiting toxicity of lenalidomide and azacitidine in patients with advanced myelodysplastic syndromes MDS
Secondary
Review clinical outcomes as defined by the International Working Group criteria in patients treated with this regimen
Determine time to transformation to acute myeloid leukemia or death in patients treated with this regimen
Determine time to relapse after achieving complete or partial remission in patients treated with this regimen
Determine time to disease progression in patients treated with this regimen
Determine the effect of this regimen on hematologic status including peripheral blood counts and the need for platelet andor red blood cell transfusions in these patients
OUTLINE This is an open-label multicenter dose-escalation study
Patients receive oral lenalidomide once daily on days 1-14 or days 1-21 and azacitidine subcutaneously once daily on days 1-5 or days 1-5 and 8-12 Treatment repeats every 28 days for up to 7 courses in the absence of relapse after achieving complete or partial remission disease progression or unacceptable toxicity
Cohorts of 3-6 patients receive escalating doses andor increasing dosing frequencies of lenalidomide and azacitidine until the maximum tolerated dose MTD is determined or the sixth dose level is reached whichever occurs first The MTD is defined as the dose preceding that at which 2 of 3 or 2 of 6 patients experience dose-limiting toxicity during the first course of therapy
After completion of study treatment patients are followed annually
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
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| CASE17Z05 | OTHER | Case Comprehensive Cancer Center | httpsreporternihgovquickSearchP30CA016042 |
| P30CA016042 | NIH | None | None |
| UCLA-0511032-01 | None | None | None |
| UCLA-RDN-5405 | None | None | None |
| UCLA-05011032-01 | None | None | None |