Ignite Creation Date:
2024-05-06 @ 8:15 PM
Last Modification Date:
2024-10-26 @ 3:23 PM
Study NCT ID:
NCT06313437
Status:
NOT_YET_RECRUITING
Last Update Posted:
2024-03-21
First Post:
2024-03-10
Brief Title:
Revumenib in Combination With 73 Midostaurin in AML
Sponsor:
Maximilian Stahl MD
Organization:
Dana-Farber Cancer Institute
Study Overview
Official Title:
A Phase I Trial of Revumenib in Combination With 73 7 Days of Cytarabine and 3 Days of Daunorubicin Midostaurin Induction Chemotherapy for the Frontline Treatment of NPM1 and FLT3 Mutated AML
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-03
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:
This research is being conducted to determine a safe and effective dose of revumenib that can be given in combination with standard induction initial therapy to induce a remission FLT3 targeted therapy midostaurin and a single cycle of post-remission therapy FLT3 targeted therapy midostaurin to participants with newly diagnosed Nucleophosmin NPM1 and FMS-like tyrosine kinase 3 FLT3 mutated Acute Myeloid Leukemia AML
The names of the study drugs involved in this study are
Revumenib SNDX-5613 a type of menin inhibitor
Midostaurin a type of multi-kinase including FLT3 inhibitor
Cytarabine a type of antineoplastic agent
Daunorubicin a type of antineoplastic agent
The names of the study drugs involved in this study are
Revumenib SNDX-5613 a type of menin inhibitor
Midostaurin a type of multi-kinase including FLT3 inhibitor
Cytarabine a type of antineoplastic agent
Daunorubicin a type of antineoplastic agent
Detailed Description:
This is a single arm open label phase I trial of the menin inhibitor revumenib in combination with cytarabine and daunorubicin 73 chemotherapy and the multikinase inhibitor midostaurin for the frontline treatment of Nucleophosmin NPM1 and FMS-like tyrosine kinase 3 FLT3 mutated Acute Myeloid Leukemia AML
Investigators are trying to determine the highest dose of revumenib that can be given safely in combination with these chemotherapy drugs Treatment consists of 1-2 cycles of so-called induction treatment initial chemotherapy to induce a remission of the leukemia This induction treatment consists of revumenib 73 7 days of cytarabine 3 days of daunorubicin chemotherapy midostaurin
The US Food and Drug Administration FDA has not approved the combination of revumenib cytarabine daunorubicin and midostaurin as a treatment for AML
The research study procedures include screening for eligibility study treatment visits blood and urine tests bone marrow biopsies and electrocardiograms ECGs
Participants will receive study treatment as long as there are no serious side effects and the disease does not progress
The trial will include up to 12 participants in dose finding phase and 10 additional participants in the dose expansion phase for a total participant number of 22 participants
Syndax Pharmaceuticals is supporting this research study by supply revumenib SNDX-5613
Investigators are trying to determine the highest dose of revumenib that can be given safely in combination with these chemotherapy drugs Treatment consists of 1-2 cycles of so-called induction treatment initial chemotherapy to induce a remission of the leukemia This induction treatment consists of revumenib 73 7 days of cytarabine 3 days of daunorubicin chemotherapy midostaurin
The US Food and Drug Administration FDA has not approved the combination of revumenib cytarabine daunorubicin and midostaurin as a treatment for AML
The research study procedures include screening for eligibility study treatment visits blood and urine tests bone marrow biopsies and electrocardiograms ECGs
Participants will receive study treatment as long as there are no serious side effects and the disease does not progress
The trial will include up to 12 participants in dose finding phase and 10 additional participants in the dose expansion phase for a total participant number of 22 participants
Syndax Pharmaceuticals is supporting this research study by supply revumenib SNDX-5613
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