Comparing Nemtabrutinib to Ibrutinib or Acalabrutinib for First Line Treatment of Chronic Lymphocytic Leukemia

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This study evaluates the effectiveness of nemtabrutinib compared to the investigator's choice of either ibrutinib or acalabrutinib in patients with chronic lymphocytic leukemia (CLL) or small lymphocytic lymphoma (SLL) who have not previously received treatment. The primary goals are to determine if nemtabrutinib is non-inferior to the comparators in terms of objective response rate and if it offers superior progression-free survival. Participants will be monitored for their response to treatment based on established criteria by independent reviewers.

Why it matters

Who can join: the full rules

Inclusion Criteria:

The main inclusion criteria include but are not limited to the following:

* Confirmed diagnosis of CLL/SLL and active disease clearly documented to have a need to initiate therapy.
* Has 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 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.

Exclusion Criteria:

The main exclusion criteria include but are not limited to the following:

* Has an active hepatitis B virus/ hepatitis C virus (HBV/HCV) infection.
* Has gastrointestinal (GI) dysfunction that may affect drug absorption.
* Has diagnosis of Richter Transformation or active central nervous system (CNS) involvement by CLL/SLL.
* Has had acquired immune deficiency syndrome (AIDS)-defining opportunistic infection in the past 12 months before screening.
* Has clinically significant cardiovascular disease.
* Has hypersensitivity to nemtabrutinib or contraindication to ibrutinib or acalabrutinib, or any of the excipients.
* Has history of severe bleeding disorder.
* Has known additional malignancy that is progressing or has required active treatment within the past 2 years.
* Has received any systemic anticancer therapy for CLL/SLL.
* 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.
* Received prior radiotherapy within 2 weeks of start of study intervention, or radiation-related toxicities, requiring corticosteroids.
* Received a live or live-attenuated vaccine within 30 days before the first dose of study intervention. Administration of killed vaccines are allowed.
* Has received an investigational agent or has used an investigational device within 4 weeks before study intervention administration.
* Has active infection requiring systemic therapy, including intravenous (IV) antibiotics during screening.
* Participants who have not adequately recovered from major surgery or have ongoing surgical complications.

Where it's running

• USA Mitchell Cancer Institute ( Site 0014)
  Mobile, Alabama, United States Recruiting
• Banner MD Anderson Cancer Center ( Site 0059)
  Gilbert, Arizona, United States Recruiting
• Banner MD Anderson Cancer Center - University Medical Center Phoenix ( Site 0051)
  Phoenix, Arizona, United States Recruiting
• Moores Cancer Center ( Site 0003)
  La Jolla, California, United States Recruiting
• Care Access - South Pasadena ( Site 0070)
  Pasadena, California, United States Recruiting
• Saint Joseph Hospital ( Site 0026)
  Denver, Colorado, United States Recruiting

+156 more sites. See ClinicalTrials.gov for the full list.

Study contacts

• Study coordinator: Toll Free Number
• Email: Trialsites@msd.com
• Phone: 1-888-577-8839

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

• Tafasitamab plus Acalabrutinib and Venetoclax for newly treated CLL/SLL

  This phase II study tests a combination of tafasitamab, acalabrutinib, and venetoclax in adults who are newly diagnosed with chronic lymphocytic leukemia or small lymphocytic lymphoma to see if it is safe and effective.

  Recruiting at 2 sites Phase 2 City of Hope Medical Center · Duarte, California and 1 other locations · NCT07582159

• Nemtabrutinib and venetoclax in untreated CLL/SLL

  This phase 2 study tests whether combining nemtabrutinib with venetoclax can help people with untreated chronic lymphocytic leukemia or small lymphocytic lymphoma.

  Recruiting Phase 2 Ohio State University Comprehensive Cancer Center · Columbus, Ohio · NCT07557056

• Intermittent versus continuous venetoclax with acalabrutinib in CLL/SLL

  This will test whether giving venetoclax intermittently or continuously together with acalabrutinib helps people with previously untreated CLL or SLL.

  Recruiting Phase 2 University of Cincinnati · Cincinnati, Ohio · NCT07014917

• Using ibrutinib to treat autoimmune hemolytic anemia in patients with chronic lymphocytic leukemia

  This study is testing if the drug ibrutinib can help adults with chronic lymphocytic leukemia who also have autoimmune hemolytic anemia feel better.

  Recruiting at 3 sites Phase 2 Gruppo Italiano Malattie EMatologiche dell'Adulto · Florence and 2 other locations · NCT05694312

• Acalabrutinib combined with venetoclax or obinutuzumab for treating chronic lymphocytic leukemia

  This study is testing if a new combination of two drugs, acalabrutinib with either venetoclax or obinutuzumab, can help people with chronic lymphocytic leukemia who haven't been treated before by reducing cancer cells in their bone marrow.

  Recruiting Phase 2 Ohio State University Comprehensive Cancer Center · Columbus, Ohio · NCT05336812

• Pirtobrutinib versus ibrutinib for people with CLL or SLL.

  This trial will test whether pirtobrutinib works better or is safer than ibrutinib for adults with CLL/SLL, with a separate part that tries pirtobrutinib alone in treatment‑naïve patients who have a 17p deletion.

  Recruiting at 93 sites Phase 3 Eli Lilly and Company · Anaheim, California and 142 other locations · NCT05254743

How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.