Study on the Effectiveness of Mirdametinib for Treating Chronic Lymphocytic Leukemia That Has Returned or Not Responded to Treatment
Sponsor: National Cancer Institute (NCI)
ClinicalTrials ID:NCT07061951
This clinical trial is testing the drug mirdametinib to see if it can help treat chronic lymphocytic leukemia (CLL) or small lymphocytic lymphoma (SLL) that has come back or not responded to previous treatments. Mirdametinib works by blocking a protein that helps cancer cells grow, which may slow or stop the spread of cancer.
Patient Parameters
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Program Overview
This study is exploring whether mirdametinib, a drug that blocks a protein involved in cancer cell growth, can effectively treat patients with chronic lymphocytic leukemia (CLL) or small lymphocytic lymphoma (SLL) that has returned after treatment or not responded to previous therapies. The trial aims to see if mirdametinib can slow down or stop the spread of cancer cells in these patients.
Description
The main goal of this study is to see how well mirdametinib works in treating CLL or SLL by measuring the response rate, which includes complete and partial responses. Researchers will also look at how long patients stay free from cancer progression, how long the response lasts, and overall survival rates. The safety and side effects of mirdametinib will also be evaluated.
Participants will take mirdametinib by mouth twice a day in 28-day cycles. These cycles will continue as long as the cancer does not progress and side effects are manageable. Throughout the study, participants will have regular tests, including blood samples, bone marrow biopsies, heart scans, and CT scans.
After finishing the treatment, participants will have follow-up visits 30 days later, then every two months until they start a new therapy, and every three months for up to five years.
Eligibility Criteria
Inclusion Criteria
- Must have a confirmed diagnosis of chronic lymphocytic leukemia (CLL) or small lymphocytic lymphoma (SLL).
- Must need treatment based on specific symptoms like enlarged spleen or lymph nodes, severe fatigue, fever, night sweats, weight loss, or worsening blood counts.
- Must have measurable disease, such as high lymphocyte count or enlarged lymph nodes.
- Must have tried at least two previous treatments, including a BTK inhibitor and a BCL2 inhibitor.
- Must be 18 years or older.
- Must be in relatively good health with a performance status score of 0 to 2.
- Must have adequate blood counts and organ function.
- Must not have active infections or untreated brain metastases.
- Must agree to use effective birth control during the study and for a period after treatment.
Exclusion Criteria
- Cannot have unresolved side effects from previous cancer treatments, except for hair loss.
- Cannot be taking other experimental drugs.
- Cannot have allergies to similar drugs as mirdametinib.
- Cannot be taking certain medications that interact with mirdametinib.
- Cannot have uncontrolled health conditions that make the study unsafe.
- Cannot be pregnant or breastfeeding.
- Cannot have active infections needing IV antibiotics.
- Cannot have certain eye conditions or heart rhythm issues.
Locations
| FACILITY | ZIP | CITY | STATE |
|---|---|---|---|
| UNC Lineberger Comprehensive Cancer Center | 27599 | Chapel Hill | North Carolina |
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