Ignite Creation Date:
2024-05-06 @ 11:24 AM
Last Modification Date:
2024-10-26 @ 12:45 PM
Study NCT ID:
NCT03512197
Status:
COMPLETED
Last Update Posted:
2023-08-21
First Post:
2018-03-26
Brief Title:
A Global Study of the Efficacy and Safety of Midostaurin Chemotherapy in Newly Diagnosed Patients With FLT3 Mutation Negative FLT3-MN Acute Myeloid Leukemia AML
Sponsor:
Novartis Pharmaceuticals
Organization:
Novartis
Study Overview
Official Title:
A Phase III Randomized Double-blind Study of Chemotherapy With Daunorubicin or Idarubicin and Cytarabine for Induction and Intermediate Dose Cytarabine for Consolidation Plus Midostaurin PKC412 or Chemotherapy Plus Placebo in Newly Diagnosed Patients With FLT-3 Mutation Negative Acute Myeloid Leukemia AML
Status:
COMPLETED
Status Verified Date:
2023-08
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:
The purpose of this study was to confirm the preliminary evidence from early clinical trials that midostaurin may provide clinical benefit not only to AML patients with the FLT3-mutations but also in FLT3-MN SR005 AML FLT3 mutant to wild type signal ratio below the 005 clinical cut-off
This study evaluated the efficacy and safety of midostaurin in combination with daunorubicin or idarubicin and cytarabine for induction and intermediate-dose cytarabine for consolidation and midostaurin single agent post-consolidation therapy in newly diagnosed patients with FLT3-MN SR005 AML
This study evaluated the efficacy and safety of midostaurin in combination with daunorubicin or idarubicin and cytarabine for induction and intermediate-dose cytarabine for consolidation and midostaurin single agent post-consolidation therapy in newly diagnosed patients with FLT3-MN SR005 AML
Detailed Description:
This was a multi-center multinational randomized double-blind Phase III study using a group sequential design Subjects were stratified according to age 60 vs 60 years Subjects within each stratum were randomized in a 11 ratio into one of two treatment arms Midostaurin chemotherapy or Placebo chemotherapy
The study consisted of the following phases
Screeningrandomization phase Subjects had to sign informed consent form before screening for enrollment Subjects started chemotherapy at day 1 and were randomized at day 8
Induction phase All subjects received at least one cycle 28 days of induction therapy with continuous infusion cytarabine D1 - D7 and daunorubicin or idarubicin D1 - D3 induction 1 Subjects who did not achieve CR or CRi with adequate blood count recovery after Induction 1 received a second cycle with intermediate-dose cytarabine D1 - D3 and daunorubicin or idarubicin D1 - D3 induction 2 Subjects who did not achieve CR or CRi with adequate blood recovery after induction 2 discontinued study treatment and were followed for survival
Consolidation phase Subjects who achieved CR or CRi with adequate blood count recovery after induction with one or two cycles of induction proceeded to consolidation therapy with either 3 or 4 cycles respectively of intermediate-dose cytarabine D1 - D3 or to Hematopoietic Stem Cells Transplantation HSCT with or without preceding consolidation cycles
Post-consolidation phase Subjects who maintained CR or CRi with adequate blood count recovery at the end of the consolidation phase received 12 cycles 28 dayscycle of continuous therapy with midostaurin or placebo twice daily at 50 mg Subjects who underwent HSCT after achieving CR or CRi with adequate blood count recovery received midostaurin or placebo twice daily 50 mg post-transplant therapy continuously for up to 12 cycles 28 dayscycle Post HSCT post-consolidation therapy began 30 days but not later than 100 days following HSCT
Follow-up phase All enrolled subjects were followed through the treatment period and until relapsetreatment failure thereafter for start of new line of therapy and survival
The study consisted of the following phases
Screeningrandomization phase Subjects had to sign informed consent form before screening for enrollment Subjects started chemotherapy at day 1 and were randomized at day 8
Induction phase All subjects received at least one cycle 28 days of induction therapy with continuous infusion cytarabine D1 - D7 and daunorubicin or idarubicin D1 - D3 induction 1 Subjects who did not achieve CR or CRi with adequate blood count recovery after Induction 1 received a second cycle with intermediate-dose cytarabine D1 - D3 and daunorubicin or idarubicin D1 - D3 induction 2 Subjects who did not achieve CR or CRi with adequate blood recovery after induction 2 discontinued study treatment and were followed for survival
Consolidation phase Subjects who achieved CR or CRi with adequate blood count recovery after induction with one or two cycles of induction proceeded to consolidation therapy with either 3 or 4 cycles respectively of intermediate-dose cytarabine D1 - D3 or to Hematopoietic Stem Cells Transplantation HSCT with or without preceding consolidation cycles
Post-consolidation phase Subjects who maintained CR or CRi with adequate blood count recovery at the end of the consolidation phase received 12 cycles 28 dayscycle of continuous therapy with midostaurin or placebo twice daily at 50 mg Subjects who underwent HSCT after achieving CR or CRi with adequate blood count recovery received midostaurin or placebo twice daily 50 mg post-transplant therapy continuously for up to 12 cycles 28 dayscycle Post HSCT post-consolidation therapy began 30 days but not later than 100 days following HSCT
Follow-up phase All enrolled subjects were followed through the treatment period and until relapsetreatment failure thereafter for start of new line of therapy and survival
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
True
Is a FDA Regulated Device?:
False
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 |
|---|---|---|---|
| 2017-003540-21 | EUDRACT_NUMBER | None | None |