Ignite Creation Date:
2025-12-24 @ 11:52 PM
Ignite Modification Date:
2025-12-25 @ 9:47 PM
Study NCT ID:
NCT07061951
Status:
NOT_YET_RECRUITING
Last Update Posted:
2025-12-15
First Post:
2025-07-11
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Testing the Effectiveness of the Anti-cancer Drug, Mirdametinib, in Treating Relapsed, Refractory Chronic Lymphocytic Leukemia
Sponsor:
National Cancer Institute (NCI)
Organization:
Study Overview
Official Title:
A Phase 2 Pilot Study of Mirdametinib in Relapsed Refractory Chronic Lymphocytic Leukemia
Status:
NOT_YET_RECRUITING
Status Verified Date:
2025-12
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 phase II trial tests the effect of mirdametinib in treating patients with chronic lymphocytic leukemia (CLL) or small lymphocytic lymphoma (SLL) that has come back after a period of improvement (relapsed) or that has not responded to previous treatment (refractory). Mirdametinib, a methyl ethyl ketone (MEK) inhibitor, works by blocking the action of an abnormal protein that signals cancer cells to multiply. This may help slow or stop the spread of cancer cells. Giving mirdametinib may be effective in treating patients with relapsed or refractory CLL or SLL.
Detailed Description:
PRIMARY OBJECTIVE:
I. To evaluate the best objective response rate (ORR) with single agent mirdametinib. ORR will be composed of complete response (CR), CR with incomplete marrow recovery (CRi), and partial remission (PR) as defined by the 2018 Modified International Workshop on Chronic Lymphocytic Leukemia (iwCLL) National Cancer Institute-Working Group (NCI-WG) criteria, which includes PR with lymphocytosis (Hallek et al., 2018).
SECONDARY OBJECTIVES:
I. To determine the effect of mirdametinib on progression-free survival (PFS). II. To evaluate the duration of response (DOR) for mirdametinib in relapsed refractory chronic lymphocytic leukemia (R/R CLL).
III. To determine the effect of mirdametinib on overall survival (OS). IV. To evaluate the safety and tolerability of mirdametinib, including the rates of high grade (3+) events, and rates of discontinuations and dose modifications.
OUTLINE:
Patients receive mirdametinib orally (PO) twice daily (BID) on days 1-28 of each cycle. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity. Additionally, patients undergo bone marrow biopsy, blood sample collection, echocardiography, and computed tomography (CT) throughout the study.
After completion of study treatment, patients are followed up at 30 days then every 2 months until starting a new therapy followed by every 3 months for up to a total of 5 years.
I. To evaluate the best objective response rate (ORR) with single agent mirdametinib. ORR will be composed of complete response (CR), CR with incomplete marrow recovery (CRi), and partial remission (PR) as defined by the 2018 Modified International Workshop on Chronic Lymphocytic Leukemia (iwCLL) National Cancer Institute-Working Group (NCI-WG) criteria, which includes PR with lymphocytosis (Hallek et al., 2018).
SECONDARY OBJECTIVES:
I. To determine the effect of mirdametinib on progression-free survival (PFS). II. To evaluate the duration of response (DOR) for mirdametinib in relapsed refractory chronic lymphocytic leukemia (R/R CLL).
III. To determine the effect of mirdametinib on overall survival (OS). IV. To evaluate the safety and tolerability of mirdametinib, including the rates of high grade (3+) events, and rates of discontinuations and dose modifications.
OUTLINE:
Patients receive mirdametinib orally (PO) twice daily (BID) on days 1-28 of each cycle. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity. Additionally, patients undergo bone marrow biopsy, blood sample collection, echocardiography, and computed tomography (CT) throughout the study.
After completion of study treatment, patients are followed up at 30 days then every 2 months until starting a new therapy followed by every 3 months for up to a total of 5 years.
Study Oversight
Has Oversight DMC:
False
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?:
False
Is an FDA AA801 Violation?:
Secondary ID Infos
| Secondary ID | Type | Domain | Link | View |
|---|---|---|---|---|
| NCI-2025-04637 | REGISTRY | CTRP (Clinical Trial Reporting Program) | View | |
| 10708 | OTHER | Dana-Farber - Harvard Cancer Center LAO | View | |
| 10708 | OTHER | CTEP | View | |
| UM1CA186709 | NIH | None | https://reporter.nih.gov/quic… | View |