Is NCT05947851 recruiting in Clermont, FL?

Yes, NCT05947851 is currently recruiting participants at its Clermont, FL location. This chronic lymphocytic leukemia clinical trial is actively enrolling qualified participants.

How do I join the chronic lymphocytic leukemia clinical trial in Clermont?

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

Is participation in this Clermont 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.

Chronic Lymphocytic Leukemia Clinical Trial in Clermont, FL

About This Chronic Lymphocytic Leukemia Study in Clermont

The purpose of this study is to assess the safety and tolerability and to confirm the dose of nemtabrutinib in combination with venetoclax in participants with R/R CLL/SLL. The primary study hypotheses are that the combination of nemtabrutinib plus venetoclax is superior to VR with respect to progression-free survival (PFS) per 2018 International Workshop on Chronic Lymphocytic Leukemia (iwCLL) criteria as assessed by blinded independent central review (BICR).

Sponsor: Merck Sharp & Dohme LLC

Who Can Participate

Inclusion Criteria

Confirmed diagnosis of chronic lymphocytic leukemia/small lymphocytic lymphoma (CLL/SLL) and active disease clearly documented to initiate therapy

Deletion (Del) (17p) status, tumor protein 53 (TP53) mutation status, and immunoglobulin heavy chain gene (IGHV) mutation status results required before randomization for Part 2 participants only

Relapsed or refractory to at least 1 prior available therapy

Have at least 1 marker of disease burden

Has an Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 2 within 7 days before randomization

Has a life expectancy of at least 3 months

Has the ability to swallow and retain oral medication

Participants who are hepatitis B surface antigen (HBsAg) positive are eligible if they have received hepatitis B virus (HBV) antiviral therapy for at least 4 weeks and have undetectable HBV deoxyribonucleic acid (DNA) viral load before randomization

Participants with history of hepatitis C virus (HCV) infection are eligible if HCV ribonucleic acid (RNA) viral load is undetectable at screening

Participants with human immunodeficiency virus (HIV) who meet ALL eligibility criteria

Participants with adequate organ function with specimens collected within 7 days before the start of study intervention

If capable of producing sperm, participant agrees to eliminate Nemtabrutinib: 12 days, Venetoclax: 1 month (30 days), Rituximab (rituximab biosimilar): not applicable; abstains from penile-vaginal intercourse as their preferred and usual lifestyle; OR uses prescribed contraception

Participant assigned female sex at birth are eligible to participate if not pregnant or breastfeeding and are not a person of childbearing potential (POCBP) OR is a POCBP and uses a contraceptive method that is highly effective, has a negative highly sensitive pregnancy test, and abstains from breastfeeding

Exclusion Criteria

Has an active hepatitis B virus/ hepatitis C virus (HBV/HCV) infection

Has gastrointestinal (GI) dysfunction that may affect drug absorption

Has a known additional malignancy that is progressing or has required active treatment within the past 2 years

Has diagnosis of Richter Transformation or active central nervous system (CNS) involvement by CLL/SLL

Has an active infection requiring systemic therapy, such as intravenous (IV) antibiotics, during screening

HIV-infected participants with a history of Kaposi's sarcoma and/or Multicentric Castleman's Disease and/or acquired immune deficiency syndrome (AIDS)-defining opportunistic infection in the past 12 months before screening

Clinically significant cardiovascular disease

Has a known allergy/sensitivity to nemtabrutinib or contraindication to venetoclax/rituximab (or rituximab biosimilar), or any of the excipients

Has history of severe bleeding disorders (eg, hemophilia)

Has received prior systemic anticancer therapy within 5 half-lives or 4 weeks (if prior therapy was a monoclonal antibody) before randomization

Has received prior B-cell lymphoma 2 inhibitor(s) (BCL2i) within ≤ 12 months before randomization or has received prior radiotherapy within 2 weeks of start of study intervention, or radiation related toxicities, requiring corticosteroids

Is currently being treated with p-glycoprotein (P-gp) substrates with a narrow therapeutic index, cytochrome P450 3A (CYP3A) strong or moderate inducers or CYP3A strong inhibitors.

Has received a live or live attenuated vaccine within 30 days before the first dose of study intervention

Has received an investigational agent or has used an investigational device within 4 weeks before study intervention administration

Has a known psychiatric or substance use disorder that would interfere with the participant's ability to cooperate with the requirements of the study

Participants who have not adequately recovered from major surgery or have ongoing surgical complications

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 Clermont?

Yes, this clinical trial (NCT05947851) has an active research site in Clermont, FL 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.

Chronic Lymphocytic Leukemia Treatment Options in Clermont, FL

If you're searching for chronic lymphocytic leukemia treatment options in Clermont, FL, this clinical trial (NCT05947851) 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 Clermont research site is actively enrolling participants for this phase 3 clinical trial. You'll receive care from experienced 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 chronic lymphocytic leukemia clinical trials near you to find additional studies recruiting in your area.

Chronic Lymphocytic Leukemia Clinical Trial in Clermont, FL

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