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Chronic Lymphocytic LeukemiaPhase 2NCT06333262

Fixed Duration Pirtobrutinib and Obinutuzumab in Chronic Lymphocytic Leukemia

A Phase 2 study testing Pirtobrutinib and Obinutuzumab in people with Chronic Lymphocytic Leukemia and Small Lymphocytic Lymphoma, run by Inhye Ahn at 4 sites 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

This study will evaluate fixed-duration therapy with pirtobrutinib and obinutuzumab given over 12 cycles (approximately 1 year) as first-line treatment of chronic lymphocytic leukemia or small lymphocytic lymphoma (CLL or SLL). Read more about this study

Who is it for?
Ages 18 years and older
What is being tested?
Pirtobrutinib and Obinutuzumab
Could I receive a placebo?
No, everyone receives an active treatment
How many people
60 participants
Where
4 sitesUnited States
Study dates
22 Apr 2024to 1 Jul 2032
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

  • Meet 2018 International Workshop on Chronic Lymphocytic Leukemia (IWCLL) guidelines for the diagnosis of chronic lymphocytic leukemia (CLL) or small lymphocytic lymphoma (SLL).
  • Presence of measurable disease (absolute lymphocyte count > 5,000/µL, palpable or measurable lymph nodes ≥1.5cm on imaging, or bone marrow involvement of CLL ≥ 30%).
  • No prior systemic therapy for CLL or SLL.
  • Currently have an indication for treatment as defined by the following 2018 IWCLL guidelines
  • Age ≥ 18 years
  • Eastern Cooperative Oncology Group performance status ≤ 2
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  • Adequate organ and bone marrow function as defined by the study protocol
  • Ability to take oral medications.
  • Ability to understand and the willingness to sign a written informed consent document.

Who cannot join

  • Known or suspected Richter's transformation or known central nervous system involvement.
  • History of bleeding disorders
  • History of stroke or intracranial hemorrhage within 6 months of starting study therapy.
  • Significant cardiovascular disease such as uncontrolled arrhythmia, Class 3 or 4 congestive heart failure as defined by the New York Heart Association Functional Classification, or left ventricular ejection fraction < 40% by any methods in the 12 months prior to study therapy.
  • History of other malignancies with life expectancy of < 2 years.
  • Receiving any other investigational agents.
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  • Concurrent systemic immunosuppression < 28 days of study therapy or administration of > 20 mg of prednisone or equivalent daily < 7 days of study therapy.
  • Vaccinated with live vaccine within 4 weeks of starting study therapy.
  • Major surgery within 4 weeks of starting study therapy.
  • Ongoing or recent infection requiring intravenous antimicrobials at time of screening. Prophylactic antibiotics are allowed if there is no evidence of active infection and the antibiotics is not included on the list of the prohibited medications.
  • Patients who have tested positive for HIV are excluded due to potential drug-drug interactions between anti-retroviral medications and pirtobrutinib and risk of opportunistic infections with both HIV and irreversible BTK inhibitors. For patients with unknown HIV status, HIV testing will be performed at Screening and result should be negative for enrollment.
  • Active human T cell leukemia virus infection or active hepatitis B or C virus infection
  • Known active cytomegalovirus infection
  • Pregnancy, lactation or plan to breastfeed during the study or within 6 months of the last dose of study treatment.
  • Clinically significant active malabsorption syndrome or other condition likely to affect gastrointestinal absorption of the study drug
  • Active uncontrolled auto-immune cytopenia.
  • Significant co-morbid condition or disease.

Trial locations and contacts

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

Hang Phan, BS contact

857-215-1258

hang_phan@dfci.harvard.edu

United States4 sites, 4 recruiting

  • Beth Israel Deaconess Medical Center

    Boston, Massachusetts, 02215

    Jon Arnason, MD

    Jon Arnason, MD

    Recruiting

  • Brigham & Women's Hospital

    Boston, Massachusetts, 02215

    Inhye Ahn

    Inhye Ahn, MD

    Recruiting

  • Dana-Farber Cancer Institute

    Boston, Massachusetts, 02215

    Megan Forsyth, 857-215-1405, megan_forsyth@dfci.harvard.edu

    Inhye Ahn, MD

    Recruiting

  • New England Cancer Specialists

    Scarborough, Maine, 04074

    Cindy Taylor, 207-303-3420, tayloc@newecs.org

    John P Winters, III, MD

    Recruiting

Other trials in United States

About this study

Official title: A Phase 2 Study of Fixed Duration Therapy With Pirtobrutinib and Obinutuzumab in Previously Untreated Chronic Lymphocytic Leukemia (POP)

This study will evaluate fixed-duration therapy with pirtobrutinib and obinutuzumab given over 12 cycles (approximately 1 year) as first-line treatment of chronic lymphocytic leukemia or small lymphocytic lymphoma (CLL or SLL).

Read the detailed description

This is an open-label, multicenter, single-arm phase 2 study of pirtobrutinib with obinutuzumab for participants with CLL or SLL. Eligible participants will receive 6 cycles of pirtobrutinib alone followed by an additional 6 cycles of pirtobrutinib-obinutuzumab combination therapy. All participants will stop treatment after 12 cycles in total (approximately 1 year).

If CLL progresses and requires treatment after 1-year of therapy, participants will receive retreatment with pirtobrutinib only. Participants will be followed for up to a total of 10 years. Up to 60 participants will take part in this study.

The U.S. Food and Drug Administration (FDA) has approved pirtobrutinib for continuous treatment of CLL that has relapsed or become refractory to other treatments. Pirtobrutinib is not approved for the first-line treatment of CLL/SLL nor for fixed-duration therapy. The FDA has approved obinutuzumab for the treatment of CLL.

The research study procedures include screening for eligibility, study treatment visits, electrocardiograms, imaging (e.g. computerized tomography or CT scans), blood tests, saliva tests, bone marrow biopsies, and/or lymph node biopsies (if feasible).

Loxo Oncology at Eli Lilly and Company is supporting this study by providing pirtobrutinib and research funding.

Being tested
Pirtobrutinib, Obinutuzumab
Keywords
Chronic Lymphocytic Leukemia, Small Lymphocytic Lymphoma, Bruton's tyrosine kinase inhibitor, Pirtobrutinib, Obinutuzumab, Fixed-duration
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

    Initial treatment:

    • Pirtobrutinib 200 mg by mouth (PO) daily from Cycle 1 Day 1 until the end of Cycle 12. Each cycle is 28 days.

    Re-treatment:

    -Pirtobrutinib 200 mg PO daily continuously

  • ObinutuzumabDrug

    Obinutuzumab is given intravenously from Cycle 7 to Cycle 12, for total 6 cycles during initial treatment only.

    Initial treatment:

    • Obinutuzumab intravenous (IV) following the standard schedule from Cycle 6 through Cycle 12 (total 6 cycles: 100 mg on Cycle 6 Day 1, 900 mg on Cycle 6 Day 2, 1000 mg on Cycle 6 Day 8 and Cycle 6 Day 15, 1000 mg on Day 1 of Cycle 7 through Cycle 12).
Study groups in NCT06333262
Study groupRoleWhat they receive
Pirtobrutinib-ObinutuzumabExperimentalEligible participants will receive initial treatment with pirtobrutinib and obinutuzumab for 12 cycles. Participants with progressive chronic lymphocytuc leukemia or small lymphocytic lymphoma during the off-treatment follow-up will receive continuous pirtobrutinib monotherapy.
Receives: Drug: Pirtobrutinib; Drug: Obinutuzumab

What is being measured

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

  1. Rate of complete response after initial therapy

    Defined by the 2018 International Workshop on Chronic Lymphocytic Leukemia (IWCLL) guidelines

    Measured: 1 year since treatment initiation

Secondary outcomes (7)

  1. Overall response rate

    Defined by the 2018 IWCLL guidelines

    Measured: 1 year since treatment initiation

  2. Rate of partial response

    Defined by the 2018 IWCLL guidelines

    Measured: 1 year since treatment initiation

  3. Time to next line of therapy

    Time from the initiation of study therapy until the next line of therapy (excluding pirtobrutinib re-treatment)

    Measured: 5 years after the last enrollment

  4. Event-free survival

    Time from the initiation of study therapy until pre-defined events (progression, death, or start of a new treatment)

    Measured: 5 years after the last enrollment

  5. Progression-free survival

    Time from the initiation of study therapy until disease progression or death

    Measured: 5 years after the last enrollment

  6. Overall survival

    Time from the initiation of study therapy until death

    Measured: 5 years after the last enrollment

  7. Rate of re-treatment with pirtobrutinib

    Rate of re-treatment with pirtobrutinib on study

    Measured: 5 years after the last enrollment

Timeline

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

  1. First posted27 Mar 2024
  2. Study start22 Apr 2024
  3. Primary completion1 Jul 2027 (estimated)
  4. Study completion1 Jul 2032 (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
Sequential
Masking
None (open label)
Enrolment
60 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06333262
Sponsor's protocol ID
24-017
Status last verified
Jan 2026
First submitted
20 Mar 2024
Last updated
21 Jan 2026
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
Yes: The Dana-Farber / Harvard Cancer Center encourages and supports the responsible and ethical sharing of data from clinical trials. De-identified participant data from the final research dataset used in the published manuscript may only be shared under the terms of a Data Use Agreement.

Publications

  • Davids MS. BRUIN 313 and 314 Trials Open the Door for Noncovalent Bruton Tyrosine Kinase Inhibition as Initial Therapy for Chronic Lymphocytic Leukemia. J Clin Oncol. 2026 Feb 20;44(6):435-439. doi: 10.1200/JCO-25-02691. Epub 2025 Dec 9.

    PubMed 41363770

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Pirtobrutinib and Obinutuzumab in people with Chronic Lymphocytic Leukemia and Small Lymphocytic Lymphoma, run by Inhye Ahn at 4 sites 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 9 inclusion and 17 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 21 Jan 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 4 sites 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 Hang Phan, BS (857-215-1258, hang_phan@dfci.harvard.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Rate of complete response after initial therapy (time frame: 1 year since treatment initiation). 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 NCT06333262, which also lists 1 linked publication.

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 21 Jan 2026.

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