Trial studying safety and effects for Recurrent Chronic Lymphocytic Leukemia
Official title Testing the Effectiveness of the Anti-cancer Drug, Mirdametinib, in Treating Relapsed, Refractory Chronic Lymphocytic Leukemia
ClinicalTrials.gov ID: NCT07061951
What this study is testing
What is Mirdametinib?
This is an investigational pill being studied to see if it can help treat chronic lymphocytic leukemia that has come back or not responded to other treatments. It is designed to block a specific protein signal that tells cancer cells to grow and multiply.
Also referred to as Gomekli, PD0325901.
Plain-language explanation of the investigational treatment. It is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- This study aims to find out if mirdametinib can help slow or stop the growth of cancer cells in patients with chronic lymphocytic leukemia or small lymphocytic lymphoma.
- Who it's for
- The study is looking for adults with chronic lymphocytic leukemia or small lymphocytic lymphoma that has come back after treatment or has not responded to previous therapy.
- What's involved
- Participants will take mirdametinib, a medication that blocks a protein that tells cancer cells to multiply, and undergo regular medical tests to monitor their health.
- Time commitment
- The source text does not specify the total duration of the study or the exact schedule of required visits.
- Phase 2: a mid-size study of how well it works
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- Patients must have histologically or cytologically confirmed CLL or small lymphocytic lymphoma (SLL), as documented by a history at some point in...
- Massive or progressive splenomegaly; OR
- Massive lymph nodes, nodal clusters, or progressive lymphadenopathy; OR
- Grade 2 or 3 fatigue; OR
- Fever ≥ 100.5°F or night sweats for greater than 2 weeks without documented infection; OR
You likely can't join if
- Patients who have not recovered from adverse events due to prior anti-cancer therapy (i.e., have residual toxicities \> grade 1) with the exception...
- Patients who are receiving any other investigational agents
- History of allergic reactions attributed to compounds of similar chemical or biologic composition to mirdametinib
- Patients with concurrent administration of strong inhibitors and inducers of P-glycoprotein (P-g)p or breast cancer specific resistance protein...
- Patients with concurrent administration of strong CYP3A4 inducers. If discontinuation of the medication is appropriate, a washout duration of...
- Patients with uncontrolled intercurrent illness or any other significant condition(s) that would make participation in this protocol unreasonably...
See the full eligibility criteria
- Patients must have histologically or cytologically confirmed CLL or small lymphocytic lymphoma (SLL), as documented by a history at some point in time of an absolute peripheral blood B cell count \> 5000/mcL with a...
- Massive or progressive splenomegaly; OR
- Massive lymph nodes, nodal clusters, or progressive lymphadenopathy; OR
- Grade 2 or 3 fatigue; OR
- Fever ≥ 100.5°F or night sweats for greater than 2 weeks without documented infection; OR
- Presence of weight loss ≥ 10% over the preceding 6 months; OR
- Progressive lymphocytosis with an increase of ≥ 50% over a 2-month period or an anticipated doubling time of less than 6 months; OR
- Evidence of progressive marrow failure as manifested by the development of or worsening of anemia and or thrombocytopenia
- Patients must have measurable disease, defined as lymphocytosis \> 5,000/mcL, palpable or computed tomography (CT) measurable lymphadenopathy \> 1.5 cm, or bone marrow involvement \> 30%
- Patients must have received at least two prior therapies for CLL including systemic therapy containing a Bruton's tyrosine kinase (BTK) inhibitor and a BCL2 inhibitor.
- Age ≥ 18 years. Because CLL is extremely rare in persons \< 18 years of age, children are excluded from this study
- Eastern Cooperative Oncology Group (ECOG) performance status ≤ 2 (Karnofsky ≥ 60%)
- Absolute neutrophil count ≥ 500/mcL. Growth factor is allowed to achieve this level. Neutrophil count of 250 is permitted for patients with bone marrow involvement
- Unless they have significant bone marrow involvement of CLL confirmed on biopsy
- Platelets ≥ 20,000/mcL independent of transfusion within 7 days of screening. Transfusion is permitted to support platelet count for patients with bone marrow involvement
- Unless they have significant bone marrow involvement of CLL confirmed on biopsy
- Total bilirubin ≤ 1.5 x institutional upper limit of normal (ULN) unless bilirubin rise is due to Gilbert's syndrome, autoimmune hemolytic anemia,(AIHA), or of non-hepatic origin
- Aspartate aminotransferase (AST) (serum glutamic oxaloacetic transaminase [SGOT])/alanine aminotransferase (ALT) (serum glutamic pyruvic transaminase [SGPT]) ≤ 3 x institutional ULN
- Glomerular filtration rate (GFR) 50 ml/min estimated using the Chronic Kidney Disease Epidemiology Collaboration (CKD-EPI) (Levey et al., 2009)
- Human immunodeficiency virus (HIV)-infected patients on effective anti-retroviral therapy with undetectable viral load within 6 months are eligible for this trial
- For patients with evidence of chronic hepatitis B virus (HBV) infection, the HBV viral load must be undetectable on suppressive therapy, if indicated
- Patients with a history of hepatitis C virus (HCV) infection must have been treated and cured. For patients with HCV infection who are currently on treatment, they are eligible if they have an undetectable HCV viral load
- Patients with treated brain metastases are eligible if follow-up brain imaging after central nervous system (CNS)-directed therapy shows no evidence of progression
- Patients with new or progressive brain metastases (active brain metastases) or leptomeningeal disease are eligible if the treating physician determines that immediate CNS specific treatment is not required and is...
- Patients with a prior or concurrent malignancy whose natural history or treatment does not have the potential to interfere with the safety or how well it works assessment of the investigational regimen are eligible for...
- Patients with known history or current symptoms of cardiac disease, or history of treatment with cardiotoxic agents, should have a clinical risk assessment of cardiac function using the New York Heart Association...
- The effects of mirdametinib on the developing human fetus are unknown. For this reason, women of child-bearing potential and men must agree to use highly effective contraception (hormonal and barrier method of birth...
- Patients who have not recovered from adverse events due to prior anti-cancer therapy (i.e., have residual toxicities \> grade 1) with the exception of alopecia
- Patients who are receiving any other investigational agents
- History of allergic reactions attributed to compounds of similar chemical or biologic composition to mirdametinib
- Patients with concurrent administration of strong inhibitors and inducers of P-glycoprotein (P-g)p or breast cancer specific resistance protein (BCRP).
- Patients with concurrent administration of strong CYP3A4 inducers. If discontinuation of the medication is appropriate, a washout duration of approximately 3 to 5 half-lives is recommended prior to the first dose of...
- Patients with uncontrolled intercurrent illness or any other significant condition(s) that would make participation in this protocol unreasonably hazardous
- Pregnant women are excluded from this study because mirdametinib is MEK inhibitor agent with the potential for teratogenic or abortifacient effects.
- Patients with active infection requiring intravenous (IV) antibiotics
- History or current evidence of glaucoma or clinically significant abnormalities on the ophthalmological exam, including but not limited to cataract limiting the ability to examine the retina or any optical coherence...
- Patients with corrected QT (QTc) \> 470 ms
The study team makes the final eligibility decision.
Where it is enrolling
- Duarte, California, United States
- Irvine, California, United States
- Sacramento, California, United States
- Boston, Massachusetts, United States
- New York, New York, United States
- Chapel Hill, North Carolina, United States
- Columbus, Ohio, United States
- Pittsburgh, Pennsylvania, United States
- Salt Lake City, Utah, United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part, but confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
This study is enrolling now at Duarte, California, United States; Irvine, California, United States; Sacramento, California, United States; Boston, Massachusetts, United States; New York, New York, United States; Chapel Hill, North Carolina, United States and 3 more locations. Enter your location above to see the nearest enrolling site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool that is independent of the study sponsor. Details come from ClinicalTrials.gov. The study team decides eligibility, and your own doctor gives medical advice.