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Chronic Lymphocytic LeukemiaPhase 2NCT06967610

Phase II Study of Combined Pirtobrutinib, Venetoclax and Obinutuzumab (PVO) Time-limited Treatment for Patients With Recurrent Chronic Lymphocytic Leukemia/Small Lymphocytic Lymphoma (CLL/SLL).

A Phase 2 study testing Pirtobrutinib, Venetoclax and Obinutuzumab in people with Chronic Lymphocytic Leukemia and Small Lymphocytic Leukemia (SLL), run by M.D. Anderson Cancer Center at 1 site in United States.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
Search all trials

Trial summary

To learn if the drug combination pirtobrutinib, venetoclax, and obinutuzumab can help to control relapsed CLL/SLL. Read more about this study

Who is it for?
Ages 18 years and older
What is being tested?
Pirtobrutinib, Venetoclax and Obinutuzumab
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
40 participants
Where
1 siteUnited States
Study dates
15 Jul 2025to 1 Jun 2033
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

None listed.

Who cannot join

  • Participants who experienced progression of disease according to 2018 iwCLL criteria while on venetoclax will be excluded.
  • Patient with prior history of Richter's syndrome or current Richter's Syndrome.
  • Participants with known hypersensitivity to any of the excipients of pirtobrutinib, venetoclax,obinutuzumab or to any intended study medications.
  • Known or suspected history of central nervous system (CNS) involvement by CLL/SLL.
  • History of bleeding diathesis.
  • Participants who experienced a major bleeding event on a prior BTK inhibitor.• NOTE: Major bleeding is defined as bleeding having one or more of the following features: life-threatening bleeding with signs or symptoms of hemodynamic compromise; bleeding associated with a decrease in the hemoglobin level of at least 2 g/dL; or bleeding in a critical area or organ (e.g., retroperitoneal, intraarticular, pericardial, epidural, or intracranial bleeding or intramuscular bleeding with compartment syndrome).
Show all 40Show fewer
  • History of stroke or intracranial hemorrhage within 6 months of enrollment.
  • Participants requiring therapeutic anticoagulation with warfarin or another vitamin K antagonists.
  • Major surgery within 4 weeks of planned start of study therapy.
  • A significant history of renal, neurologic, psychiatric, endocrine, metabolic or immunologic disorder, that, in the opinion of the Investigator, would adversely affect the participant's participation in this study or interpretation of study outcomes.
  • History of allogeneic or autologous stem cell transplant (SCT) or chimeric antigen receptor-modified Tcell (CAR-T) therapy within 60 days of enrollment or presence of any of the following, regardless of prior SCT and/or CAR-T therapy timing:
  • active graft versus host disease (GVHD);
  • cytopenia from incomplete blood cell count recovery post-transplant;
  • need for anti-cytokine therapy for toxicity from CAR-T therapy; residual symptoms of neurotoxicity > Grade 1 from CAR-T therapy;
  • ongoing immunosuppressive therapy (> 20 mg prednisone or equivalent daily).
  • Active uncontrolled auto-immune cytopenia (e.g., autoimmune hemolytic anemia [AIHA], idiopathic thrombocytopenic purpura [ITP]) for which new therapy was introduced or existing therapy was escalated within the 4 weeks prior to study enrollment to maintain adequate blood counts.
  • Participants who experienced grade >3 arrhythmia on prior treatment with BTK inhibitor.
  • Significant cardiovascular disease, defined as any of the following:
  • Unstable angina or acute coronary syndrome within the past 2 months.
  • History of myocardial infarction within 6 months prior to planned start of study treatment.
  • Documented left ventricular ejection fraction (LVEF) by any method of ≤ 45% in the 12 months prior to planned start of study treatment.
  • ≥ Grade 3 New York Heart Association (NYHA) functional classification system of heart failure.
  • uncontrolled or symptomatic arrhythmias
  • Prolongation of the QT interval corrected (QTc - see Appendix 3) for heart rate using Fredericia's Formula (QTcF) > 470 msec on an EKG during screening.
  • QTcF is calculated using Fredericia's Formula (QTcF = QT/(RR^0.33)
  • Correction of suspected drug-induced QTcF prolongation or prolongation due to electrolyte abnormalities can be attempted at the Investigator's discretion, and only if clinically safe to do so with either discontinuation of the offending drug or switch to another drug not known to be associated with QTcF prolongation or electrolyte supplementation.
  • Correction of QTc for underlying bundle branch block (BBB) permissible. Participants with pacemakers are eligible if they have no history of fainting or clinically relevant arrhythmias while using the pacemaker
  • Hepatitis B or hepatitis C testing indicating active/ongoing infection based on screening laboratory tests as defined as:
  • Hepatitis B virus (HBV): Participants with positive hepatitis B surface antigen (HBsAg) are excluded. Participants with positive hepatitis B core antibody (anti-HBc) and negative HBsAg require hepatitis B polymerase chain reaction (PCR) evaluation. Participants who are hepatitis B PCR positive will be excluded.
  • Hepatitis C virus (HCV): positive hepatitis C antibody. If positive hepatitis C antibody result, participant will need to have a negative result for hepatitis C ribonucleic acid (RNA) . Participants who are hepatitis C RNA positive will be excluded.
  • Evidence of other clinically significant uncontrolled condition(s) including, but not limited to, uncontrolled systemic infection (viral, bacterial, parasitic or fungal) or other clinically significant active disease process which in the opinion of the Principal Investigator may pose a risk for patient participation. Screening for chronic conditions is not required.
  • Known Human Immunodeficiency Virus (HIV) infection, regardless of CD4 count. For participants with unknown HIV status, HIV testing will be performed at screening and result must be negative for enrollment.
  • Known active CMV infection. Participants with unknown or negative status are eligible.
  • Vaccination with live vaccine within 28 days prior to enrollment
  • Clinically significant active malabsorption syndrome or other condition likely to affect gastrointestinal (GI) absorption of the oral administered study treatments.
  • Active other malignancy unless in remission and with life expectancy > 2 years. with exception of participants diagnosed with basal cell or squamous cell carcinoma of the skin or carcinoma "in situ" of the cervix or breast who are eligible even if diagnosed within 2 years. If Participants have another malignancy that was treated within the last 2 years, such participants may be enrolled, if the likelihood of requiring systemic therapy for this other malignancy within 2 years is less than 10%, as determined by an expert in that particular malignancy at MD Anderson Cancer Center, and after consultation with the Principal Investigator.
  • Current treatment with strong cytochrome P450 3A4 (CYP3A4) inhibitors or inducers. A washout period of at least 5 half-lives of these agents following discontinuation before study entry is required (treatment with moderate CYP3A4 inhibitors or inducers is not excluded). Because of their effect on CYP3A4, use of any of the following within 7 days of study therapy start or planned use during study participation is prohibited i. Grapefruit or grapefruit products ii. Seville oranges or products from Seville oranges iii. Star fruit.
  • Current treatment with the following P-gp inhibitors: amiodarone, clarithromycin, cyclosporine, erythromycin, ketoconazole, and verapamil. A washout period of at least 5 half-lives of the inhibitor before study entry is required.
  • Participants that are pregnant or plan to become pregnant during the study or within 1 month of the last dose of study treatment.
  • 25) Participants that are lactating or plan to breastfeed during the study or within 1 week of the last dose of study treatment.

Trial locations and contacts

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

Alessandra Ferrajoli, MD contact

713-792-2063

aferrajo@mdanderson.org

United States1 site, 1 recruiting

  • MD Anderson Cancer Center

    Houston, Texas, 77030

    Alessandra Ferrajoli, MD, 713-792-2063, aferrajo@mdanderson.org

    Alessandra Ferrajoli, MD

    Recruiting

Other trials in United States

About this study

To learn if the drug combination pirtobrutinib, venetoclax, and obinutuzumab can help to control relapsed CLL/SLL.

Read the detailed description

Primary Objective:

  • Rate of bone marrow undetectable Measurable Residual Disease (10-4 sensitivity; uMRD4) at end of Cycle 13.

Secondary Objectives:

  • Blood uMRD6 rate at end of cycles 9, 13, 19, 25.
  • 2018 iwCLL response rates defined as complete response (CR), CR with incomplete count recovery (CRi), partial response (PR), overall response (OR), stable disease (SD), and progressive disease (PD) at cycle 13.
  • Progression-free (PFS) and overall survival (OS); time to blood uMRD6 relapse; safety and tolerability.
Being tested
Pirtobrutinib, Venetoclax, Obinutuzumab
Medical subject headings
Leukemia, Lymphocytic, Chronic, B-Cell

What participants receive

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

  • PirtobrutinibDrug

    Given PO 200mg daily

  • VenetoclaxDrug

    Given PO daily

  • ObinutuzumabDrug

    Given IV 100mg day 1, 900 mg day 2, 100mg days 8, 15

Study groups in NCT06967610
Study groupRoleWhat they receive
V-ExposedExperimentalVenetoclax Exposed: Treatment with Pirtobrutinib+Venetoclax+Obinutuzumab Q4W
Receives: Drug: Pirtobrutinib; Drug: Venetoclax; Drug: Obinutuzumab
V-NaiveExperimentalVenetoclax Naive: Treatment with Pirtobrutinib+Venetoclax+Obinutuzumab Q4W
Receives: Drug: Pirtobrutinib; Drug: Venetoclax; Drug: Obinutuzumab

What is being measured

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

  1. Safety and adverse events

    Incidence of Adverse Events, Graded According to National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) Version 5

    Measured: Through study completion; an average of 1 year.

Timeline

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

  1. First posted13 May 2025
  2. Study start15 Jul 2025
  3. Primary completion1 Jun 2031 (estimated)
  4. Study completion1 Jun 2033 (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
Non-randomised
Intervention model
Single group
Masking
None (open label)
Enrolment
40 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06967610
Sponsor's protocol ID
2025-0271
Other IDs
NCI-2025-03338
Status last verified
Oct 2026
First submitted
5 May 2025
Last updated
3 Nov 2026
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Pirtobrutinib, Venetoclax and Obinutuzumab in people with Chronic Lymphocytic Leukemia and Small Lymphocytic Leukemia (SLL), run by M.D. Anderson Cancer Center 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 0 inclusion and 40 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: looking for participants now, as of the sponsor's last update on 3 Nov 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 Alessandra Ferrajoli, MD (713-792-2063, aferrajo@mdanderson.org), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Safety and adverse events (time frame: Through study completion; an average of 1 year.). 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 NCT06967610.

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 3 Nov 2026.

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