Fixed-duration treatment for chronic lymphocytic leukemia with pirtobrutinib and obinutuzumab

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This clinical trial evaluates a fixed-duration therapy combining pirtobrutinib and obinutuzumab for patients with chronic lymphocytic leukemia (CLL) or small lymphocytic lymphoma (SLL). Participants will receive 6 cycles of pirtobrutinib alone, followed by 6 cycles of the combination therapy, totaling approximately one year of treatment. The study aims to assess the efficacy and safety of this regimen as a first-line treatment option. Participants will be monitored for up to 10 years to evaluate long-term outcomes.

Why it matters

Who can join: the full rules

Key Inclusion Criteria:

* 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
* 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.

Key Exclusion Criteria:

* 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.
* 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.

Where it's running

• New England Cancer Specialists
  Scarborough, Maine, United States Recruiting
• Beth Israel Deaconess Medical Center
  Boston, Massachusetts, United States Recruiting
• Brigham & Women's Hospital
  Boston, Massachusetts, United States Recruiting
• Dana-Farber Cancer Institute
  Boston, Massachusetts, United States Recruiting

Study contacts

• Principal investigator: Inhye E Ahn, MD — Dana-Farber Cancer Institute
• Study coordinator: Hang Phan, BS
• Email: hang_phan@dfci.harvard.edu
• Phone: 857-215-1258

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

• NX-5948 vs Pirtobrutinib in R/R CLL/SLL

  This study tests NX-5948 against pirtobrutinib in people with relapsed or refractory CLL/SLL who have previously tried a covalent BTK inhibitor.

  Recruiting at 6 sites Phase 3 Nurix Therapeutics, Inc. · Macon, Georgia and 5 other locations · NCT07516093

• Venetoclax plus obinutuzumab followed by epcoritamab for untreated CLL/SLL

  This trial tests whether giving venetoclax and obinutuzumab followed by epcoritamab can produce deep remissions in people with previously untreated chronic lymphocytic leukemia or small lymphocytic lymphoma.

  Recruiting at 4 sites Phase 2 City of Hope Medical Center · Duarte, California and 6 other locations · NCT07218510

• Epcoritamab given after 2nd-generation BTK inhibitors for CLL/SLL

  This trial will try giving subcutaneous epcoritamab for up to 12 cycles to adults with CLL/SLL who have been on a second‑generation BTK inhibitor for at least 12 months to see if it can deepen responses to a complete remission with undetectable MRD so therapy can be stopped.

  Recruiting Phase 2 University of Cincinnati · Cincinnati, Ohio · NCT07108998

• LP-168 plus obinutuzumab for previously treated and BTK T474I‑mutated CLL/SLL

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  Recruiting Phase 2 University of Cincinnati · Cincinnati, Ohio · NCT06978088

• Comparing a BTK-targeted protein degrader (BGB-16673) with pirtobrutinib for adults with relapsed or refractory CLL or SLL

  This trial tests whether BGB-16673 works better and is as safe as pirtobrutinib for adults whose CLL or SLL has come back or not responded after prior covalent BTK inhibitor treatment.

  Recruiting at 217 sites Phase 3 BeOne Medicines · Birmingham, Alabama and 216 other locations · NCT06973187

• Time-limited combination of pirtobrutinib, venetoclax and obinutuzumab for relapsed CLL/SLL

  This trial will test whether a time-limited combination of pirtobrutinib, venetoclax, and obinutuzumab can control relapsed CLL/SLL in adults who have had prior therapy.

  Recruiting Phase 2 M.D. Anderson Cancer Center · Houston, Texas · NCT06967610

How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.