Ignite Creation Date:
2024-05-06 @ 4:35 PM
Last Modification Date:
2024-10-26 @ 2:13 PM
Study NCT ID:
NCT05038592
Status:
RECRUITING
Last Update Posted:
2024-07-03
First Post:
2021-06-01
Brief Title:
Tagraxofusp and Decitabine for the Treatment of Chronic Myelomonocytic Leukemia
Sponsor:
MD Anderson Cancer Center
Organization:
MD Anderson Cancer Center
Study Overview
Official Title:
Phase III Study of Tagraxofusp in Combination With Decitabine for Patients With Chronic Myelomonocytic Leukemia
Status:
RECRUITING
Status Verified Date:
2024-07
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 best dose and effect of tagraxofusp and decitabine in treating patients with chronic myelomonocytic leukemia Tagraxofusp consists of human interleukin 3 IL3 linked to a toxic agent called DT388 IL3 attaches to IL3 receptor positive cancer cells in a targeted way and delivers DT388 to kill them Chemotherapy drugs such as decitabine 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 Giving tagraxofusp and decitabine may help to control the disease in patients with chronic myelomonocytic leukemia
Detailed Description:
PRIMARY OBJECTIVES
I To determine the safety tolerability and maximum tolerable dose MTD of tagraxofusp-erzs tagraxofusp in combination with decitabine
II To assess overall response OR rate to tagraxofusp in combination with decitabine
SECONDARY OBJECTIVES
I To assess overall survival OS duration of response relapse-free survival RFS and safety profile
II Correlative studies
OUTLINE This is a phase I dose-escalation study of tagraxofusp-erzs followed by a phase II study
Patients receive decitabine intravenously IV over 60 minutes on days 1-5 and tagraxofusp-erzs IV over 15 minutes on days 1-3 Cycles of decitabine repeat every 28 days in the absence of disease progression or unacceptable toxicity Treatment with tagraxofusp-erzs repeats every 28 days for up to 7 cycles in the absence of disease progression or unacceptable toxicity
After completion of study treatment patients are followed up every 3 months
I To determine the safety tolerability and maximum tolerable dose MTD of tagraxofusp-erzs tagraxofusp in combination with decitabine
II To assess overall response OR rate to tagraxofusp in combination with decitabine
SECONDARY OBJECTIVES
I To assess overall survival OS duration of response relapse-free survival RFS and safety profile
II Correlative studies
OUTLINE This is a phase I dose-escalation study of tagraxofusp-erzs followed by a phase II study
Patients receive decitabine intravenously IV over 60 minutes on days 1-5 and tagraxofusp-erzs IV over 15 minutes on days 1-3 Cycles of decitabine repeat every 28 days in the absence of disease progression or unacceptable toxicity Treatment with tagraxofusp-erzs repeats every 28 days for up to 7 cycles in the absence of disease progression or unacceptable toxicity
After completion of study treatment patients are followed up every 3 months
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 |
|---|---|---|---|
| 2020-0895 | OTHER | M D Anderson Cancer Center | None |
| NCI-2021-04293 | REGISTRY | None | None |