AzTrials
AzTrials

Chronic Lymphocytic LeukemiaPhase 2NCT07690891

Nemtabrutinib With Venetoclax and Obinutuzumab in Patients With Chronic Lymphocytic Leukemia

A Phase 2 study testing Nemtabrutinib, Venetoclax and Obinutuzumab in people with Chronic Lymphocytic Leukemia, run by Medical College of Wisconsin at 1 site in United States.

Not yet recruiting

Opening soon. The study is approved but enrolment has not started yet. Sites may already take enquiries.

Sites and contacts
Official record
Search all trials

Trial summary

This is a single-arm, open-label Phase 2 study designed to evaluate the treatment outcomes of nemtabrutinib-venetoclax-obinutuzumab as a frontline management for chronic lymphocytic leukemia (CLL). Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Chronic Lymphocytic Leukemia
What is being tested?
Nemtabrutinib, Venetoclax and Obinutuzumab
Could I receive a placebo?
No, everyone receives an active treatment
How many people
30 participants
Where
1 siteUnited States
Study dates
1 Oct 2026to 1 Sep 2031
Phase
Phase 2
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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).
Show all 31Show fewer
  • 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:
  • Total bilirubin ≤1.5 x upper limit of normal (ULN) OR direct bilirubin ≤ULN for participants with total bilirubin levels >1.5 × ULN. Patients with Gilbert's syndrome can enroll if conjugated bilirubin is within normal limits and total bilirubin ≤3 x ULN).
  • Serum aspartate aminotransferase (AST) and alanine aminotransferase (ALT) ≤3 x ULN.
  • 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:
  • Agree to practice one highly effective method and one additional effective (barrier) method of contraception, at the same time, from the time of signing the informed consent through six months after the last dose of study drug (female and male condoms should not be used together), OR ii. 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], withdrawal, spermicides only, and lactational amenorrhea are not acceptable methods of contraception).
  • Agree to not to donate or freeze egg(s) during the course of this study or within 180 days after receiving their last dose of study drug.
  • 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.
  • Note: Participants should remain on anti-viral therapy throughout study intervention and follow local guidelines for HBV anti-viral therapy post completion of study intervention. Hepatitis B screening tests should include HBsAg and anti-HBV.
  • 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).
  • HIV screening tests are not required unless known history of HIV infection
  • Ability to understand a written informed consent document, and the willingness to sign it.

Who cannot join

  • Active HBV/HCV infection. See inclusion criteria 9 (HBV) and 10 (HCV) for requirements.
  • 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.
Show all 31Show fewer
  • 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.
  • NOTE: The time requirement does not apply to participants who underwent successful definitive resection of basal cell carcinoma of the skin, squamous cell carcinoma of the skin, or carcinoma in situ, excluding carcinoma in situ of the bladder.
  • A person of childbearing potential who has a positive urine pregnancy test within 72 hours prior to allocation (see Appendix 3). If the urine test is positive or cannot be confirmed as negative, a serum pregnancy test will be required.
  • Note: in the event that 72 hours have elapsed between the screening pregnancy test and the first dose of study treatment, another pregnancy test (urine or serum) must be performed and must be negative in order for subject to start receiving study medication.
  • Prior/Concomitant Therapy
  • 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.
  • Note: Two weeks or fewer of palliative radiotherapy for non-CNS disease, with a 1-week washout, is permitted.
  • Has received a live vaccine or live-attenuated vaccine within 30 days before the first dose of study intervention. Administration of killed vaccines are allowed.
  • Prior/Concurrent Clinical Study Experience
  • 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.
  • Diagnostic Assessments
  • Has not adequately recovered after 4 weeks from major surgery or has ongoing surgical complications.
  • Note: Biopsy and placement of central venous access devices are not considered major surgery.
  • Has known psychiatric or substance abuse disorders that would interfere with cooperation with the requirements of the trial.

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

Medical College of Wisconsin Cancer Center Clinical Trials Office contact

866-680-0505 ext. 8900

cccto@mcw.edu

United States1 site

  • Froedtert & the Medical College of Wisconsin

    Milwaukee, Wisconsin, 53226

    Guru Guru Murthy, MD, 414-805-4600, gmurthy@mcw.edu

Other trials in United States

About this study

Official title: Phase II Study of Nemtabrutinib With Venetoclax and Obinutuzumab in Patients With Chronic Lymphocytic Leukemia

This is a single-arm, open-label Phase 2 study designed to evaluate the treatment outcomes of nemtabrutinib-venetoclax-obinutuzumab as a frontline management for chronic lymphocytic leukemia (CLL).

Read the detailed description

The primary objective of this study is to determine the rate of undetectable minimal residual disease (MRD) with this therapy. Secondary objectives include assessment of response, adverse event profile, and survival. Patients with treatment-naïve CLL who meet the eligibility criteria would be initiated on treatment as described below.

Patients will start nemtabrutinib monotherapy for the first 3 cycles, followed by the addition of obinutuzumab for 6 cycles (during Cycles 4-9) and venetoclax for 12 cycles (during Cycles 4-15) while continuing nemtabrutinib, for a total duration of 15 cycles of combined therapy.

Being tested
Nemtabrutinib, Venetoclax, Obinutuzumab
Keywords
minimal residual disease
Medical subject headings
Leukemia, Lymphocytic, Chronic, B-Cell, Neoplasm, Residual

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • NemtabrutinibDrug

    Also called MK-1026

    45 mg daily for 15 28-day cycles.

  • VenetoclaxDrug

    Also called Venclexta, Venclyxto

    Cycle 4, Days 1-7: 20 mg; Cycle 4, Days 8-14: 50 mg; Cycle 4, Days 15-21: 100 mg; Cycle 4, Days 22-28: 200 mg; Cycle 5-15: 400 mg.

  • ObinutuzumabDrug

    Also called Gazyva

    Cycle 4, Day 1: 100 mg; Cycle 4, Day 2: 900 mg; Cycle 4, Day 8: 1000 mg; Cycle 4, Day 15: 1000 mg; Cycles 5-9, Day 1: 1000 mg.

Study groups in NCT07690891
Study groupRoleWhat they receive
Nemtabrutinib with Venetoclax and ObinutuzumabExperimental* Nemtabrutinib will be administered orally. * Venetoclax will be administered orally * Obinutuzumab will be administered intravenously.
Receives: Drug: Nemtabrutinib; Drug: Venetoclax; Drug: Obinutuzumab

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Undetectable MRD

    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.

    Measured: 15 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted8 Jul 2026
  2. Study start1 Oct 2026 (estimated)
  3. Primary completion1 Dec 2029 (estimated)
  4. Study completion1 Sep 2031 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
30 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07690891
Sponsor's protocol ID
IIT-GURU-NEMTABRUTINIB-CLL
Status last verified
Jul 2026
First submitted
1 Jul 2026
Last updated
8 Jul 2026
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Nemtabrutinib, Venetoclax and Obinutuzumab in people with Chronic Lymphocytic Leukemia, run by Medical College of Wisconsin at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 31 inclusion and 31 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: opening soon, as of the sponsor's last update on 8 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Medical College of Wisconsin Cancer Center Clinical Trials Office (866-680-0505 ext. 8900, cccto@mcw.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Undetectable MRD (time frame: 15 months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT07690891.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Jul 2026.

AzTrials uses cookies for analytics and advertising. You can accept or reject them; the site works either way. Privacy Policy.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in