Trial comparing treatments for Chronic Lymphocytic Leukemia
Official title A Study of Nemtabrutinib (MK-1026) Versus Comparator (Investigator's Choice of Ibrutinib or Acalabrutinib) in First Line (1L) Chronic Lymphocytic Leukemia (CLL)/ Small Lymphocytic Lymphoma (SLL) (MK-1026-011/BELLWAVE-011)
ClinicalTrials.gov ID: NCT06136559
What this study is testing
What is Nemtabrutinib?
Nemtabrutinib is an investigational oral medicine being studied as a potential treatment for chronic lymphocytic leukemia (CLL) and small lymphocytic lymphoma (SLL). It is designed to inhibit BTK, a protein involved in B‑cell signaling.
Also referred to as MK‑1026, ARQ 531.
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
- The study compares how well nemtabrutinib works against the other two drugs in terms of how many patients respond and how long they stay free of disease progression.
- Who it's for
- Adults who have not yet received any treatment for chronic lymphocytic leukemia or small lymphocytic lymphoma.
- What's involved
- Participants will receive either nemtabrutinib or the drug chosen by their doctor (ibrutinib or acalabrutinib) and will have regular visits and tests to monitor their response and disease status.
- Time commitment
- The study lasts until the patient’s disease progresses or the study ends, with scheduled visits and tests throughout the treatment period.
- Phase 3: a large, late-stage study
- This is a blinded study.
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
- 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...
You likely can't join if
- 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.
See the full eligibility criteria
- 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)...
- 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.
- 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.
The study team makes the final eligibility decision.
Where it is enrolling
- Mobile, Alabama, United States
- Gilbert, Arizona, United States
- Phoenix, Arizona, United States
- La Jolla, California, United States
- Pasadena, California, United States
- Denver, Colorado, United States
- Golden, Colorado, United States
- Grand Junction, Colorado, United States
- Norwich, Connecticut, United States
- Boca Raton, Florida, United States
- Clermont, Florida, United States
- Fort Myers, Florida, United States
- West Palm Beach, Florida, United States
- Boise, Idaho, United States
- Fort Wayne, Indiana, United States
- Iowa City, Iowa, United States
- Waukee, Iowa, United States
- Edgewood, Kentucky, United States
- Owensboro, Kentucky, United States
- Grand Rapids, Michigan, United States
+ 144 more site(s).
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 Mobile, Alabama, United States; Gilbert, Arizona, United States; Phoenix, Arizona, United States; La Jolla, California, United States; Pasadena, California, United States; Denver, Colorado, United States and 158 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.