To hear about similar clinical trials, please enter your email below

Trial Title: Fixed Duration Pirtobrutinib and Obinutuzumab in Chronic Lymphocytic Leukemia

NCT ID: NCT06333262

Condition: Chronic Lymphocytic Leukemia
Small Lymphocytic Lymphoma

Conditions: Official terms:
Leukemia
Leukemia, Lymphoid
Leukemia, Lymphocytic, Chronic, B-Cell
Obinutuzumab
Pirtobrutinib

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

Study type: Interventional

Study phase: Phase 2

Overall status: Recruiting

Study design:

Allocation: N/A

Intervention model: Sequential Assignment

Primary purpose: Treatment

Masking: None (Open Label)

Intervention:

Intervention type: Drug
Intervention name: Pirtobrutinib
Description: 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
Arm group label: Pirtobrutinib-Obinutuzumab

Intervention type: Drug
Intervention name: Obinutuzumab
Description: 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).
Arm group label: Pirtobrutinib-Obinutuzumab

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).

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.

Criteria for eligibility:
Criteria:
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.

Gender: All

Minimum age: 18 Years

Maximum age: N/A

Healthy volunteers: No

Locations:

Facility:
Name: New England Cancer Specialists

Address:
City: Scarborough
Zip: 04074
Country: United States

Status: Recruiting

Contact:
Last name: Cindy Taylor

Phone: 207-303-3420
Email: tayloc@newecs.org

Investigator:
Last name: John P Winters, III, MD
Email: Principal Investigator

Facility:
Name: Beth Israel Deaconess Medical Center

Address:
City: Boston
Zip: 02215
Country: United States

Status: Recruiting

Contact:
Last name: Jon Arnason, MD

Investigator:
Last name: Jon Arnason, MD
Email: Principal Investigator

Facility:
Name: Brigham & Women's Hospital

Address:
City: Boston
Zip: 02215
Country: United States

Status: Recruiting

Contact:
Last name: Inhye Ahn

Investigator:
Last name: Inhye Ahn, MD
Email: Principal Investigator

Facility:
Name: Dana-Farber Cancer Institute

Address:
City: Boston
Zip: 02215
Country: United States

Status: Recruiting

Contact:
Last name: Megan Forsyth

Phone: 857-215-1405
Email: megan_forsyth@dfci.harvard.edu

Investigator:
Last name: Inhye Ahn, MD
Email: Principal Investigator

Start date: April 22, 2024

Completion date: February 1, 2029

Lead sponsor:
Agency: Inhye Ahn
Agency class: Other

Collaborator:
Agency: Loxo Oncology, Inc.
Agency class: Industry

Source: Dana-Farber Cancer Institute

Record processing date: ClinicalTrials.gov processed this data on November 12, 2024

Source: ClinicalTrials.gov page: https://clinicaltrials.gov/ct2/show/NCT06333262

Login to your account

Did you forget your password?