Is NCT07061951 recruiting in Chapel Hill, NC?

Yes, NCT07061951 is currently recruiting participants at its Chapel Hill, NC location. This recurrent chronic lymphocytic leukemia clinical trial is actively enrolling qualified participants.

Is participation in this Chapel Hill clinical trial free?

Yes, all study-related care is provided at no cost to qualified participants. Many studies also offer compensation for time and travel expenses.

Recurrent Chronic Lymphocytic Leukemia Clinical Trial in Chapel Hill, NC

Q: How do I join the recurrent chronic lymphocytic leukemia clinical trial in Chapel Hill?

To join this clinical trial in Chapel Hill, complete the eligibility form on this page. A study coordinator will contact you to discuss next steps and determine if you qualify.

About This Recurrent Chronic Lymphocytic Leukemia Study in Chapel Hill

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.

Sponsor: National Cancer Institute (NCI)

Who Can Participate

Inclusion 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 monoclonal B cell population coexpressing CD19, CD5, and CD23, or if CD23 negative, then documentation of the absence of t(11;14) or cyclin D1 overexpression. Alternatively, patients with lymphadenopathy in the absence of circulating disease will also be eligible for this study if lymph node biopsy or bone marrow biopsy has established the diagnosis of CLL with the above immunophenotype

Patients must have a current indication for treatment as defined by the iwCLL 2018 Guidelines (Hallek et al., 2018):

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. Patients are required to have prior BTK inhibitor-based therapy because constitutive extracellular signal-regulated kinase (ERK) activation is seen in all patients with progression after BTK inhibitor therapy

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 unlikely to be required during the first cycle of therapy

Patients with a prior or concurrent malignancy whose natural history or treatment does not have the potential to interfere with the safety or efficacy assessment of the investigational regimen are eligible for this trial

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 Functional Classification. To be eligible for this trial, patients should be class II or better

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 control; abstinence) prior to study entry and for the duration of study participation. Should a woman become pregnant or suspect she is pregnant while she or her partner is participating in this study, she should inform her treating physician immediately. Women of child-bearing potential should also use adequate contraception for 6 months after completion of mirdametinib administration. Men treated or enrolled on this protocol must also agree to use adequate contraception prior to the study, for the duration of study participation, and 3 months after completion of mirdametinib administration. Women of childbearing age should not donate egg(s) and men should not donate sperm for the duration of study participation and 3 months after completion of mirdametinib administration

Exclusion Criteria

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). 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 mirdametinib

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 mirdametinib

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. Because there is an unknown but potential risk for adverse events in nursing infants secondary to treatment of the mother mirdametinib, breastfeeding should be discontinued if the mother is treated with mirdametinib

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 tomography (OCT) finding that could be a significant risk factor for retinal vein occlusion (RVO), retinopathy, or neovascular macular degeneration

Patients with corrected QT (QTc) \> 470 ms

Not sure if you qualify? Submit your interest and a study coordinator will help determine your eligibility.

Frequently Asked Questions

Q:Is this study available in Chapel Hill?

Yes, this clinical trial (NCT07061951) has an active research site in Chapel Hill, NC that is currently enrolling participants.

Q:Is it safe to participate?

Clinical trials follow strict safety guidelines and ethical standards. This study has been reviewed and approved, and participants are closely monitored by medical professionals. You can withdraw at any time.

Q:Will I be compensated?

Many clinical trials offer compensation for your time and travel expenses. Specific compensation details will be discussed during the screening process. All study-related medical care is provided at no cost.

Q:Can I leave the trial if I change my mind?

Absolutely. Participation is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty.

Still have questions? Our study coordinators are here to help.

Recurrent Chronic Lymphocytic Leukemia Treatment Options in Chapel Hill, NC

If you're searching for recurrent chronic lymphocytic leukemia treatment options in Chapel Hill, NC, this clinical trial (NCT07061951) may be an excellent opportunity. Clinical trials provide access to cutting-edge treatments that aren't yet available to the general public, often at no cost to participants.

Our Chapel Hill research site is actively enrolling participants for this clinical trial. You'll receive care from experienced recurrent chronic lymphocytic leukemia specialists who are at the forefront of medical research. All study-related care, including examinations, treatments, and monitoring, is provided at no cost to qualified participants.

Looking for more options? Browse all recurrent chronic lymphocytic leukemia clinical trials near you to find additional studies recruiting in your area.

Recurrent Chronic Lymphocytic Leukemia Clinical Trial in Chapel Hill, NC

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