RECRUITING

Fixed Duration Pirtobrutinib and Obinutuzumab in Chronic Lymphocytic Leukemia

Conditions

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

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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).

Official Title

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

Quick Facts

Study Start:2024-04-22

Study Completion:2032-07-01

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:RECRUITING

Study ID

NCT06333262

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years

Sexes Eligible for Study:ALL

Accepts Healthy Volunteers:No

Standard Ages:ADULT, OLDER_ADULT

Inclusion Criteria	Exclusion 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.	* 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.

Inclusion Criteria

Exclusion 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.

* 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.

Contacts and Locations

Study Contact

Hang Phan, BS

CONTACT

857-215-1258

hang_phan@dfci.harvard.edu

Principal Investigator

Inhye E Ahn, MD

PRINCIPAL_INVESTIGATOR

Dana-Farber Cancer Institute

Study Locations (Sites)

New England Cancer Specialists

Scarborough, Maine, 04074

United States

Beth Israel Deaconess Medical Center

Boston, Massachusetts, 02215

United States

Brigham & Women's Hospital

Boston, Massachusetts, 02215

United States

Dana-Farber Cancer Institute

Boston, Massachusetts, 02215

United States

Collaborators and Investigators

Sponsor: Inhye Ahn

Inhye E Ahn, MD, PRINCIPAL_INVESTIGATOR, Dana-Farber Cancer Institute

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2024-04-22

Study Completion Date2032-07-01

Study Record Updates

Study Start Date2024-04-22

Study Completion Date2032-07-01

Terms related to this study

Keywords Provided by Researchers

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

Additional Relevant MeSH Terms

Chronic Lymphocytic Leukemia
Small Lymphocytic Lymphoma