Ignite Creation Date:
2025-12-25 @ 4:12 AM
Ignite Modification Date:
2025-12-26 @ 3:11 AM
Study NCT ID:
NCT06817720
Status:
RECRUITING
Last Update Posted:
2025-10-15
First Post:
2025-02-04
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Phase II Study Assessing the Efficacy and Toxicity of Olverembatinib Monotherapy in Patients With Newly Diagnosed Chronic Myeloid Leukemia in Chronic Phase
Sponsor:
M.D. Anderson Cancer Center
Organization:
Study Overview
Official Title:
Phase II Study Assessing the Efficacy and Toxicity of Olverembatinib Monotherapy in Patients With Newly Diagnosed Chronic Myeloid Leukemia in Chronic Phase
Status:
RECRUITING
Status Verified Date:
2025-10
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:
To learn if olverembatinib can help to control newly diagnosed CML in the chronic phase.
Detailed Description:
Primary Objectives
* To assess the rate of MMR by 12 months. Secondary Objectives
* To assess the rate of CCyR by 12 months.
* To estimate the proportion of participants with 4.5-log reduction of BCR::ABL1 transcripts (MR4.5) at 6, 12, 18, 24, and 36 months of therapy.
* To estimate the rate of sustained deep molecular response.
* To estimate event-free survival and overall survival.
* To assess the toxicity of olverembatinib monotherapy.
* To assess health-related quality of life (HRQOL) of the participants.
* To assess the rate of MMR by 12 months. Secondary Objectives
* To assess the rate of CCyR by 12 months.
* To estimate the proportion of participants with 4.5-log reduction of BCR::ABL1 transcripts (MR4.5) at 6, 12, 18, 24, and 36 months of therapy.
* To estimate the rate of sustained deep molecular response.
* To estimate event-free survival and overall survival.
* To assess the toxicity of olverembatinib monotherapy.
* To assess health-related quality of life (HRQOL) of the participants.
Study Oversight
Has Oversight DMC:
True
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?:
True
Is an FDA AA801 Violation?:
Secondary ID Infos
| Secondary ID | Type | Domain | Link | View |
|---|---|---|---|---|
| NCI-2025-00934 | OTHER | NCI-CTRP Clinical Registry | View |