Ignite Creation Date:
2024-05-06 @ 8:03 PM
Last Modification Date:
2024-10-26 @ 3:19 PM
Study NCT ID:
NCT06235801
Status:
RECRUITING
Last Update Posted:
2024-06-04
First Post:
2024-01-23
Brief Title:
A Phase III Study of Gilteritinib and Momelotinib for Patients With Relapsed or Refractory FLT3-Mutated Acute Myeloid Leukemia
Sponsor:
MD Anderson Cancer Center
Organization:
MD Anderson Cancer Center
Study Overview
Official Title:
A Phase III Study of Gilteritinib and Momelotinib for Patients With Relapsed or Refractory FLT3-Mutated Acute Myeloid Leukemia
Status:
RECRUITING
Status Verified Date:
2024-06
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
To learn the recommended dose of momelotinib that can be given in combination with gilteritinib to participants with AML
Detailed Description:
Primary Objectives
Phase I To establish the minimum safe and biologically-effective dose of momelotinib in combination with gilteritinib in relapsedrefractory FLT3-mutated AML
Phase II To determine the modified CRc rate of the regimen including complete remission CR CR with incomplete hematologic recovery CRi or morphologic leukemia free state MLFS
Secondary Objectives
To assess other efficacy endpoints CR rate measurable residual disease negativity by flow cytometry and FLT3 PCR relapse-free survival overall survival
To assess proportion of participants proceeding to allogeneic hematopoietic stem cell transplantation
To determine the safety of the combination regimen
Exploratory Objectives
To evaluate the impact of baseline genomic alterations on response and survival of the combination regimen
To determine the impact of baseline FLT3 allelic ratio on response and survival
To evaluate the pharmacokinetics eg AUC Cmax Tmax and half-life of momelotinib in the combination regimen
To evaluate changes in circulating cytokine levels in response to treatment
To evaluate inhibition of FLT3 signaling and inhibition of JAKSTAT signaling pathways
To evaluate other biomarkers associated with response and resistance to the combination regimen
Phase I To establish the minimum safe and biologically-effective dose of momelotinib in combination with gilteritinib in relapsedrefractory FLT3-mutated AML
Phase II To determine the modified CRc rate of the regimen including complete remission CR CR with incomplete hematologic recovery CRi or morphologic leukemia free state MLFS
Secondary Objectives
To assess other efficacy endpoints CR rate measurable residual disease negativity by flow cytometry and FLT3 PCR relapse-free survival overall survival
To assess proportion of participants proceeding to allogeneic hematopoietic stem cell transplantation
To determine the safety of the combination regimen
Exploratory Objectives
To evaluate the impact of baseline genomic alterations on response and survival of the combination regimen
To determine the impact of baseline FLT3 allelic ratio on response and survival
To evaluate the pharmacokinetics eg AUC Cmax Tmax and half-life of momelotinib in the combination regimen
To evaluate changes in circulating cytokine levels in response to treatment
To evaluate inhibition of FLT3 signaling and inhibition of JAKSTAT signaling pathways
To evaluate other biomarkers associated with response and resistance to the combination regimen
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 |
|---|---|---|---|
| NCI-2024-00669 | OTHER | NCI-CTRP Clinical Registry | None |