Chapel Hill, NCNCT06708897Now EnrollingIRB Ready

CLL / SLL Clinical Trial in Chapel Hill, NC

Access cutting-edge cll / sll treatment through this phase 1 clinical trial at a research site in Chapel Hill. Study-provided care at no cost to qualified participants.

Sponsored by Lomond Therapeutics Holdings, Inc.

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Expert Care in Chapel Hill

Access cll / sll specialists at no cost

IRB Approved

This study follows strict safety protocols and ethical guidelines

No-Cost Care

All study-related cll / sll treatment provided free

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Check if you qualify for this cll / sll clinical trial in Chapel Hill, NC

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Why Participate?

  • No-Cost Study Care

  • Local to Chapel Hill

    Convenient for NC residents

  • Cutting-Edge Treatment

    Access to innovative therapies

  • Expert Medical Care

    Close monitoring by specialists

  • Possible Compensation*

    For time and travel

*Compensation varies by study. Confirm details with coordinator.

Simple Process

  1. 1Submit this form
  2. 2Phone screening
  3. 3Visit Chapel Hill site if eligible
  4. 4Begin participation

About This CLL / SLL Study in Chapel Hill

This is a clinical study aiming to evaluate the safety, pharmacokinetics, pharmacodynamics, and preliminary efficacy of ZE50-0134 in relapsed and refractory chronic lymphocytic leukemia, small lymphocytic lymphoma, and select low-grad lymphomas.

Sponsor: Lomond Therapeutics Holdings, Inc.

Who Can Participate

Inclusion Criteria

Men and women aged ≥18 years.
Disease as defined below: Part 1: Patients with symptomatic CLL or SLL (defined by iwCLL) without del(17p)/TP53 must have received ≥2 prior therapies that have included a BTKi and venetoclax (or declined this) or Patients with progressive low-grade lymphoma that includes marginal zone lymphoma, lymphoplasmacytic lymphoma (including Waldenstrom's macroglobulinemia) who have received at least 2 therapies including a BTKi and CD20 antibody-based therapy. Part 2: Patients with symptomatic CLL or SLL (defined by iwCLL) must have received ≥1 prior therapies that have included a BTKi and be venetoclax naive.
Prior to beginning part 2, an activation amendment will be submitted to the FDA that includes safety, pharmacokinetics, pharmacodynamics and early efficacy data from the Part 1 portion. At this time, we may also include cohorts of specific types of low-grade lymphoma as well. Adequate bone marrow, liver, and renal functions as assessed by the following laboratory requirements to be conducted within 7 days before the first dose of study drug:
Absolute neutrophil count (ANC) \> 0.75 x 109/L. For subjects with documented bone marrow involvement ≥ 0.5 x 109/L
Platelet count \> 50 x 109/L. For subjects with documented bone marrow involvement ≥ 30 x 109/L
Serum aspartate transaminase (AST/SGOT) or alanine transaminase (ALT/SGPT) ≤ 3.0 x upper limit of normal (ULN)
Total bilirubin ≤ 1.5 x ULN
Creatinine or Cystatin C glomerular filtration rate (GFR) ≥60 mL/min. Estimated GFR (eGFR) according to the Modification of Diet in Renal Disease Study Group (MDRD) formula and expressed in mL/min. To convert mL/min/1.73 m2 to mL/min multiply by the individual's BSA calculated using an appropriate formula and divide by 1.73 Eastern Cooperative Oncology Group (ECOG) performance status of 2 or less Negative serum or urine pregnancy test must be obtained within 7 days before the first dose of study drug in women of childbearing potential. Negative results must also be available before each cycle. Postmenopausal women, as defined below, are exempt from pregnancy testing:
Age \>50 years with amenorrhea for at least 12 months or
Age ≤50 years with 6 months of spontaneous amenorrhea and follicle stimulating hormone (FSH) level within postmenopausal range (\>40 mIU/mL) OR
Permanently sterilized women (e.g., hysterectomy, bilateral salpingectomy, or uterine ablation) Women and men of reproductive potential must agree to use highly effective contraception when sexually active. This applies for the period between signing of the informed consent and 90 days after the last administration of study drug. These methods should be documented in source documents. The investigator or a designated associate is requested to advise the subject on how to achieve highly effective birth control. Ability to understand and the willingness to sign a written informed consent. A signed informed consent (including consent for genetic biomarker

Exclusion Criteria

Subjects will be excluded from the study if they display any of the following criteria:
FOR PART 2 ONLY \- No prior venetoclax treatment FOR BOTH PARTS ALL THE FOLLOWING APPLY:
Know active Richter's transformation. Patients who have been treated for this diagnosis and have been in remission for \> 2 years without evidence of this and who have only CLL are considered eligible
Known hypersensitivity to the study drug or excipients of the preparation or any agent given in association with this study.
Clinically significant cardiac disease including congestive heart failure \> New York Heart Association (NYHA) Class II, evidence for uncontrolled coronary artery disease (e.g., unstable angina (anginal symptoms at rest) or new-onset angina (within the last 6 months or myocardial infarction within the past 6 months before first dose, major regional wall motion abnormalities upon baseline echocardiography), and cardiac arrhythmias requiring anti- arrhythmic therapy except for beta-blockers and digoxin.
Known Active cytomegalovirus (CMV), hepatitis B or C virus infection.
Known Active SARS-CoV-2 infection; prior SARS-CoV-2 infection allowed if completely recovered \> 14 days.
Active clinically serious infections of Grade \>2, requiring parenteral therapy; Subjects may be eligible after infection resolves.
Uncontrolled autoimmune hemolytic anemia or idiopathic thrombocytopenic purpura within 28 days of enrolment.
Allogeneic bone marrow transplant within 4 months before first dose of study drug (Subjects must have completed immunosuppressive therapy before enrollment).
Active cancer that limits expected survival to \< 2 years or requires active therapy concomitant with this treatment. Exclusions would be localized skin cancer, breast cancer, prostate cancer that are resected or malignancies treated with hormonal or immune therapies alone. All cases of secondary cancer should be discussed with the medical monitor.
A physical exam or laboratory finding that contraindicates the use of investigational therapy or otherwise places the subject at excessively high risk for treatment, as determined by the investigator. A discussion between the investigator and sponsor regarding eligibility is encouraged for such cases.
Unresolved toxicity of previous treatments (excluding cases of alopecia) Grade ≥2.
Requires ongoing immunosuppressive therapy, including systemic (e.g., intravenous or oral) corticosteroids for the treatment of cancer or other conditions. Note: Subjects may use topical or inhaled corticosteroids or low-dose steroids (≤10 mg of prednisone or equivalent per day) as therapy for comorbid conditions. Short courses of steroids before first dose are allowed for tumor flare.
Major surgery or significant trauma within 4 weeks before the first dose of study drug.
Breastfeeding women: breastfeeding women have to discontinue breastfeeding before onset of and during treatment and should be discontinued for at least 3 months after end of treatment.
Subjects with QTcF \> 470 msec that cannot be corrected with electrolyte replacement, hydration, or medication modifications.

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 (NCT06708897) 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.

CLL / SLL Treatment Options in Chapel Hill, NC

If you're searching for cll / sll treatment options in Chapel Hill, NC, this clinical trial (NCT06708897) 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 phase 1 clinical trial. You'll receive care from experienced cll / sll 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 cll / sll clinical trials near you to find additional studies recruiting in your area.

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