Ignite Creation Date:
2024-05-06 @ 8:30 AM
Last Modification Date:
2024-10-26 @ 12:01 PM
Study NCT ID:
NCT02752035
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
2024-06-12
First Post:
2016-04-22
Brief Title:
A Study of ASP2215 Gilteritinib by Itself ASP2215 Combined With Azacitidine or Azacitidine by Itself to Treat Adult Patients Who Have Recently Been Diagnosed With Acute Myeloid Leukemia With a FLT3 Gene Mutation and Who Cannot Receive Standard Chemotherapy
Sponsor:
Astellas Pharma Global Development Inc
Organization:
Astellas Pharma Inc
Study Overview
Official Title:
A Phase 3 Multicenter Open-label Randomized Study of ASP2215 Gilteritinib Combination of ASP2215 Plus Azacitidine and Azacitidine Alone in the Treatment of Newly Diagnosed Acute Myeloid Leukemia With FLT3 Mutation in Patients Not Eligible for Intensive Induction Chemotherapy
Status:
ACTIVE_NOT_RECRUITING
Status Verified Date:
2024-10
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
True
If Expanded Access, NCT#:
NCT03070093
Has Expanded Access, NCT# Status:
APPROVED_FOR_MARKETING
Acronym:
None
Brief Summary:
This is a clinical study for adult patients who have recently been diagnosed with acute myeloid leukemia or AML AML is a type of cancer It is when bone marrow makes white blood cells that are not normal These are called leukemia cells Some patients with AML have a mutation or change in the FLT3 gene This gene helps leukemia cells make a protein called FLT3 This protein causes the leukemia cells to grow faster
For patients with AML who cannot receive standard chemotherapy azacitidine also known as Vidaza is a current standard of care treatment option in the United States This clinical study is testing an experimental medicine called ASP2215 also known as gilteritinib Gilteritinib works by stopping the leukemia cells from making the FLT3 protein This can help stop the leukemia cells from growing faster
This study will compare two different treatments Patients are assigned to one of these two groups by chance a medicine called azacitidine also known as Vidaza or an experimental medicine gilteritinib in combination with azacitidine There is a twice as much chance to receive both medicines combined than azacitidine alone The clinical study may help show which treatment helps patients live longer
For patients with AML who cannot receive standard chemotherapy azacitidine also known as Vidaza is a current standard of care treatment option in the United States This clinical study is testing an experimental medicine called ASP2215 also known as gilteritinib Gilteritinib works by stopping the leukemia cells from making the FLT3 protein This can help stop the leukemia cells from growing faster
This study will compare two different treatments Patients are assigned to one of these two groups by chance a medicine called azacitidine also known as Vidaza or an experimental medicine gilteritinib in combination with azacitidine There is a twice as much chance to receive both medicines combined than azacitidine alone The clinical study may help show which treatment helps patients live longer
Detailed Description:
Patients considered an adult according to local regulation at the time of obtaining informed consent may participate in the study
Safety Cohort Prior to initiation of the randomized trial 8 to 12 patients will be enrolled to evaluate the safety and tolerability of ASP2215 given with azacitidine therapy in the study population
Randomized Trial Approximately 250 patients will be randomized in a 21 ratio to receive ASP2215 plus azacitidine Arm AC or azacitidine only Arm C Patients will enter the screening period up to 14 days prior to the start of treatment Patients will be administered treatment over 28-day cycles
Earlier protocol versions included a 111 randomization ratio to receive Arm A ASP2215 Arm AC ASP2215 azacitidine or Arm C azacitidine Patients previously randomized to Arm A should continue following treatment and assessments as outlined in the protocol
Safety Cohort Prior to initiation of the randomized trial 8 to 12 patients will be enrolled to evaluate the safety and tolerability of ASP2215 given with azacitidine therapy in the study population
Randomized Trial Approximately 250 patients will be randomized in a 21 ratio to receive ASP2215 plus azacitidine Arm AC or azacitidine only Arm C Patients will enter the screening period up to 14 days prior to the start of treatment Patients will be administered treatment over 28-day cycles
Earlier protocol versions included a 111 randomization ratio to receive Arm A ASP2215 Arm AC ASP2215 azacitidine or Arm C azacitidine Patients previously randomized to Arm A should continue following treatment and assessments as outlined in the protocol
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 |
|---|---|---|---|
| 2015-001790-41 | EUDRACT_NUMBER | None | None |