Nemtabrutinib, Venetoclax, and Obinutuzumab for Chronic Lymphocytic Leukemia
This study is testing a new combination of three drugs – nemtabrutinib, venetoclax, and obinutuzumab – as an initial treatment for chronic lymphocytic leukemia (CLL). Researchers want to see how well this combination works to reduce the amount of cancer cells in your body to undetectable levels, which is called undetectable minimal residual disease (MRD). They will also look at how patients respond to the treatment, any side effects, and how long patients live. You might be able to join if you are 18 or older, have CLL that needs treatment, and meet certain health criteria. The study plans to enroll 30 participants, but its current status is unclear.
- Study design
- This is a single-arm, open-label Phase 2 study, meaning all participants receive the same treatment and both you and your doctors will know which drugs you are receiving. It plans to enroll 30 participants.
- What's involved
- You would start with nemtabrutinib alone for 3 cycles, then add obinutuzumab for 6 cycles and venetoclax for 12 cycles, continuing nemtabrutinib throughout, for a total of 15 cycles of combined therapy.
- Compensation
- Not stated in the trial record.
- Follow-up
- The primary goal is measured at 15 months, which suggests follow-up for at least that duration after starting treatment.
AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.
NCT07690891
Nemtabrutinib With Venetoclax and Obinutuzumab in Patients With Chronic Lymphocytic Leukemia
Not Yet Recruiting
PHASE2Ages 18+InterventionalTreatmentMedical College of WisconsinInvestigator-initiated
~30 participants
Updated 2026-07-08 on ClinicalTrials.gov
What's tested:NemtabrutinibVenetoclaxObinutuzumab
At a glance
Recruiting sites
0 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Undetectable MRD
Measured over 15 months
Conditions
NCT07690891
Where you'd take part
This study runs at 1 site. They're the same protocol — you choose where, and that choice sets who your contact draft is addressed to.
Froedtert & the Medical College of Wisconsin
Milwaukee, Wisconsinstudy coordinator listed
Sites open and close at different times, so the status above is per site — it can differ from the study's overall status.
Study leadership
- Guru S Guru Murthy, MD · PRINCIPAL_INVESTIGATOR · Medical College of Wisconsin
Who to contact
Medical College of Wisconsin Cancer Center Clinical Trials Office
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Eligibility criteria
Inclusion
Patients aged 18 years or older.
Patients must have a diagnosis of CLL/ Small Lymphocytic Lymphoma (SLL)
Patients must meet International Workshop on Chronic Lymphocytic Leukemia (iwCLL) criteria for treatment initiation.
Eastern Cooperative Oncology Group (ECOG) performance status of 0-2
Patient must meet the following screening clinical laboratory values as specified below:
Hematologic: Absolute Neutrophil Count (ANC) of at least 1000 and platelet count of at least 50,000 unless these blood counts are low due to bone marrow involvement by CLL/SLL (use of growth factors, transfusions allowed to meet this criteria as clinically indicated).
International normalized ratio (INR) OR prothrombin time (PT) ≤1.5 × Upper Limit of Normal (ULN) unless participant is receiving anticoagulant therapy as long as PT or PTT is within therapeutic range of intended use of anticoagulants.
Hepatic:
Renal: Creatinine clearance of at least 30 mL/min based either on Cockroft-Gault estimate or Chronic Kidney Disease Epidemiology Collaboration (CKD-EPI) or urine collection (12 or 24 hour).
Patient is able to swallow oral medications.
Female subjects who:
Are postmenopausal for at least one year before the screening visit, OR
Are surgically sterile, OR
If they are of childbearing potential:
Male subjects, even if surgically sterilized (i.e., status post vasectomy), who:
Agree to practice effective barrier contraception during the entire study treatment period from the time of signing the informed consent through and through six months after the last dose of study drug (female and male condoms should not be used together), OR
Agree to practice true abstinence, when this is in line with the preferred and usual lifestyle of the subject. (periodic abstinence \[e.g., calendar, ovulation, symptothermal, post-ovulation methods for the female partner\] withdrawal, spermicides only, and lactational amenorrhea are not acceptable methods of contraception.)
Agree to not to donate or freeze sperm during the course of this study or within 180 days after receiving their last dose of study drug.
Participants who are hepatitis B surface antigen (HBsAg) positive are eligible if they have received HBV antiviral therapy for at least 4 weeks and have undetectable Hepatitis B (HBV) viral load at screening.
Participants with history of Hepatitis C Virus (HCV) infection are eligible if HCV viral load is undetectable at screening. Participants must have completed curative anti-viral therapy at least 4 weeks prior to randomization.
Participants with HIV are eligible if they meet ALL of the following criteria:
The CD4 count is \>350 cells/µL at screening
The HIV viral load is below the detectable level as per locally available testing
Are on a stable antiretroviral therapy (ART) regimen for at least 4 weeks prior to study entry i. Note: ART must include drugs which are NOT strong CYP3A4 inducers (participants receiving ART that are strong CYP3A4 inducers are not eligible to be included in the study).
Gastrointestinal dysfunction that may affect drug absorption (e.g., gastric bypass surgery, gastrectomy).
Diagnosis of Richter Transformation
Active central nervous system (CNS) involvement
Active infection requiring systemic therapy, including IV antibiotics during screening. Participants may be rescreened followed completion of IV antibiotic course.
AIDS defining opportunistic infection in the past 12 months prior to screening.
History or current evidence of any condition, therapy, or laboratory abnormality that might confound the results of the study, interfere with the participant's participation for the full duration of the study, or is not in the best interest of the participant to participate, in the opinion of the treating investigator.
Clinically significant cardiac issues (unless patient has a pacemaker) such as QTc prolongation (defined as a QTcF \>480 msecs) or other significant electrocardiogram (ECG) abnormalities including second degree AV block type II, third degree AV block, or bradycardia (ventricular rate less than 50 beats/min)
Known allergy/sensitivity to nemtabrutinib or any of the excipients
History of severe bleeding disorder defined as an ongoing congenital or acquired condition that leads to an increased likelihood of bleeding.
History of a second malignancy, unless potentially curative treatment has been completed with no evidence of malignancy for 2 years or no active therapy is needed.
Prior use of any BTKi or Bcl2 inhibitor
Currently being treated with the following drugs:
P-gp substrates with a narrow therapeutic index
CYP3A strong inducers
CYP3A strong inhibitors NOTE: A washout period of at least 5 times the half-life after the last dose of any of the above treatments is required for a participant to be eligible for study enrollment.
Has received prior systemic anti-cancer therapy including investigational agents within 4 weeks (if prior therapy was a monoclonal antibody) or 5 half-lives before randomization, whichever is longer.
Has received prior radiotherapy within 2 weeks of start of study intervention or radiation-related toxicities requiring corticosteroids.
Is currently enrolled on another therapeutic clinical trial. Concurrent enrollment on another therapeutic clinical trial or any trial designed to impact the efficacy of anti-cancer therapy is prohibited.
Has received an investigational agent or has used an investigational device within 4 weeks prior to study intervention administration.
What this trial measures
- Undetectable MRD15 months
This measure is the proportion of subjects with undetectable MRD at 10\^-4 sensitivity level by flow cytometry after treatment with nemtabrutinib, venetoclax, and obinutuzumab for frontline management of CLL.