Actively Recruiting
Phase 2 Study of Mirdametinib for Treating Relapsed or Refractory Chronic Lymphocytic Leukemia and Small Lymphocytic Lymphoma
Led by National Cancer Institute (NCI) · Updated on 2026-07-31
20
Participants Needed
8
Research Sites
N/A
Total Duration
AI-Summary
What this Trial Is About
Researchers are evaluating the drug mirdametinib in patients with chronic lymphocytic leukemia CLL or small lymphocytic lymphoma SLL that has returned after improvement or has not responded to previous treatments. This phase II trial focuses on how mirdametinib, a MEK inhibitor, may block abnormal proteins that promote cancer cell growth, potentially slowing or stopping the disease spread in relapsed or refractory cases. Participants take mirdametinib orally twice daily for 28-day cycles, continuing as long as the disease does not progress and side effects are manageable. Throughout the study, patients undergo bone marrow biopsies, blood tests, echocardiograms, and CT scans to assess their condition. After treatment ends, follow-up visits occur at 30 days, then every two months until new therapy begins, followed by every three months for up to five years. During the trial, researchers monitor the best objective response rate, progression-free survival, duration of response, overall survival, and safety including severe side effects and treatment discontinuations. Assessments include imaging and laboratory tests, with long-term follow-up lasting up to five years to understand mirdametinibs effects and tolerability in this patient group.
CONDITIONS
Brief Title
Testing the Effectiveness of the Anti-cancer Drug, Mirdametinib, in Treating Relapsed, Refractory Chronic Lymphocytic Leukemia
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