Ignite Creation Date:
2024-05-06 @ 3:01 PM
Last Modification Date:
2024-10-26 @ 1:41 PM
Study NCT ID:
NCT04493138
Status:
RECRUITING
Last Update Posted:
2024-07-03
First Post:
2020-07-27
Brief Title:
Azacitidine and Quizartinib for the Treatment of Myelodysplastic Syndrome or MyelodysplasticMyeloproliferative Neoplasm With FLT3 or CBL Mutations
Sponsor:
MD Anderson Cancer Center
Organization:
MD Anderson Cancer Center
Study Overview
Official Title:
Phase III Study of Azacitidine in Combination With Quizartinib for Patients With Myelodysplastic Syndromes and MyelodysplasticMyeloproliferative Neoplasms With FLT3 or CBL Mutations
Status:
RECRUITING
Status Verified Date:
2024-10
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:
This phase III trial studies the side effects and best dose of quizartinib when given with azacitidine and to see how well they work in treating patients with myelodysplastic syndrome or myelodysplasticmyeloproliferative neoplasm with FLT3 or CBL mutations Chemotherapy drugs such as azacitidine work in different ways to stop the growth of cancer cells either by killing the cells by stopping them from dividing or by stopping them from spreading Quizartinib may stop the growth of cancer cells by blocking some of the enzymes needed for cell growth Giving azacitidine and quizartinib may help to control myelodysplastic syndrome or myelodysplasticmyeloproliferative neoplasm
Detailed Description:
PRIMARY OBJECTIVES
I To determine the safety tolerability and maximum tolerable dose MTD of quizartinib in combination with azacytidine
II To assess overall response ORR rate to quizartinib in combination with azacitidine
SECONDARY OBJECTIVES
I To assess overall survival OS duration of response leukemia-free survival LFS relapse-free survival RFS and safety profile
II Correlative studies
OUTLINE This is a phase I dose-escalation study of quizartinib followed by a phase II study
Patients receive azacitidine subcutaneously SC or intravenously IV over about 30 minutes on days 1-5 and quizartinib orally PO once daily QD on days 1-28 Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity
After completion of study treatment patients are followed up at 30 days
I To determine the safety tolerability and maximum tolerable dose MTD of quizartinib in combination with azacytidine
II To assess overall response ORR rate to quizartinib in combination with azacitidine
SECONDARY OBJECTIVES
I To assess overall survival OS duration of response leukemia-free survival LFS relapse-free survival RFS and safety profile
II Correlative studies
OUTLINE This is a phase I dose-escalation study of quizartinib followed by a phase II study
Patients receive azacitidine subcutaneously SC or intravenously IV over about 30 minutes on days 1-5 and quizartinib orally PO once daily QD on days 1-28 Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity
After completion of study treatment patients are followed up at 30 days
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 |
|---|---|---|---|
| 2019-1178 | OTHER | M D Anderson Cancer Center | None |
| NCI-2020-05261 | REGISTRY | None | None |