Ignite Creation Date:
2024-05-06 @ 12:45 PM
Last Modification Date:
2024-10-26 @ 1:03 PM
Study NCT ID:
NCT03836209
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
2024-02-22
First Post:
2019-02-07
Brief Title:
Gilteritinib vs Midostaurin in FLT3 Mutated Acute Myeloid Leukemia
Sponsor:
PrECOG LLC
Organization:
PrECOG LLC
Study Overview
Official Title:
Randomized Trial of Gilteritinib vs Midostaurin in FLT3 Mutated Acute Myeloid Leukemia AML
Status:
ACTIVE_NOT_RECRUITING
Status Verified Date:
2024-02
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:
Eligible untreated patients with FLT3 acute myeloid leukemia AML between the ages of 18 and 70 will be randomized to receive gilteritinib or midostaurin during induction and consolidation Patients will also receive standard chemotherapy of daunorubicin and cytarabine during induction and high-dose cytarabine during consolidation
Gilteritinib is an oral drug that works by stopping the leukemia cells from making the FLT3 protein This may help stop the leukemia cells from growing faster and thus may help make chemotherapy more effective Gilteritinib has been approved by the Food and Drug Administration FDA for patients who have relapsed or refractory AML with a FLT3 mutation but is not approved by the FDA for newly diagnosed FLT3 AML and its use in this setting is considered investigational
Midostaurin is an oral drug that works by blocking several proteins on cancer cells including FLT3 that can help leukemia cells grow Blocking this pathway can cause death to the leukemic cells Midostaurin is approved by the FDA for the treatment of FLT3 AML
The purpose of this study is to compare the effectiveness of gilteritinib to midostaurin in patients receiving combination chemotherapy for FLT3 AML
Gilteritinib is an oral drug that works by stopping the leukemia cells from making the FLT3 protein This may help stop the leukemia cells from growing faster and thus may help make chemotherapy more effective Gilteritinib has been approved by the Food and Drug Administration FDA for patients who have relapsed or refractory AML with a FLT3 mutation but is not approved by the FDA for newly diagnosed FLT3 AML and its use in this setting is considered investigational
Midostaurin is an oral drug that works by blocking several proteins on cancer cells including FLT3 that can help leukemia cells grow Blocking this pathway can cause death to the leukemic cells Midostaurin is approved by the FDA for the treatment of FLT3 AML
The purpose of this study is to compare the effectiveness of gilteritinib to midostaurin in patients receiving combination chemotherapy for FLT3 AML
Detailed Description:
Approximately one third of patients with AML have a particular change in their leukemia cells called a mutation in a gene called FLT3 The presence of a FLT3 mutation can be used to direct treatment options
This is an open-label phase II study Patients will receive standard chemotherapy of daunorubicin and cytarabine during Induction and high-dose cytarabine during Consolidation Patients will be randomized to gilteritinib or midostaurin After approximately 90 patients complete treatment a review of the effectiveness of gliteritinib compared to midostaurin will be done If gilteritinib is not as effective as midostaurin the study may be stopped
Bone marrow aspirate and biopsy will be done on Day 21 after start of Induction and after Induction to assess response Patients with a complete response may proceed to consolidation chemotherapy Another bone marrow aspirate and biopsy will be done after the first cycle of consolidation is complete
Mandatory prescreening bone marrow andor blood samples are required for FLT3 testing Any left-over samples will be requested for future research optional
Mandatory bone marrow samples for research are required after Induction and if patient receives Consolidation after the first cycle of Consolidation
This is an open-label phase II study Patients will receive standard chemotherapy of daunorubicin and cytarabine during Induction and high-dose cytarabine during Consolidation Patients will be randomized to gilteritinib or midostaurin After approximately 90 patients complete treatment a review of the effectiveness of gliteritinib compared to midostaurin will be done If gilteritinib is not as effective as midostaurin the study may be stopped
Bone marrow aspirate and biopsy will be done on Day 21 after start of Induction and after Induction to assess response Patients with a complete response may proceed to consolidation chemotherapy Another bone marrow aspirate and biopsy will be done after the first cycle of consolidation is complete
Mandatory prescreening bone marrow andor blood samples are required for FLT3 testing Any left-over samples will be requested for future research optional
Mandatory bone marrow samples for research are required after Induction and if patient receives Consolidation after the first cycle of Consolidation
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?:
False
Is an FDA AA801 Violation?:
None