Study on Pirtobrutinib for Treating Elderly Patients with Chronic Lymphocytic Leukemia (CLL)

Sponsor: Jennifer Woyach

Sponsor score: 0

ClinicalTrials ID:NCT07685717

Provider View

This clinical trial is exploring how well the drug pirtobrutinib works in treating older adults with chronic lymphocytic leukemia (CLL). The study aims to see if pirtobrutinib can be more effective than other similar drugs in treating CLL in patients aged 75 and older.

Patient Parameters

Program Overview

This study is testing the effectiveness of pirtobrutinib, a drug that blocks a protein called BTK, which helps cancer cells grow. The trial focuses on elderly patients with chronic lymphocytic leukemia (CLL) to see if pirtobrutinib can work better than other BTK inhibitors like ibrutinib, acalabrutinib, and zanubrutinib, especially in cases where resistance to these drugs develops over time.

Description

The main goal of this study is to see how many patients stop taking pirtobrutinib and how many respond positively to it after 12 cycles of treatment. The study also looks at the safety and effectiveness of pirtobrutinib in treating CLL and its impact on patients' quality of life.

Participants will take pirtobrutinib by mouth once a day for 28 days in each cycle. These cycles will continue as long as the disease does not progress and the treatment is tolerated well. Throughout the study, participants will have CT scans, blood tests, and bone marrow tests to monitor their condition.

After finishing the treatment, participants will have follow-up visits within 7-30 days and then every 6 months for up to 8 years to check on their health and any long-term effects of the treatment.

Eligibility Criteria

Inclusion Criteria

  • Must be 75 years or older.
  • Have a diagnosis of chronic lymphocytic leukemia (CLL) or small lymphocytic lymphoma (SLL).
  • Have not received any prior treatment for CLL, except for certain allowed treatments like local radiation or specific medications for symptom control.
  • Need treatment according to specific medical guidelines.
  • Be in relatively good health with an ECOG performance status of 3 or lower.
  • Have liver and kidney function within specified limits based on blood tests.
  • Have adequate blood cell counts, with some exceptions if CLL affects bone marrow.
  • Male participants must use effective birth control if sexually active with a woman of childbearing potential.
  • Be able to take oral medications.
  • Understand the study and agree to participate by signing a consent form.

Exclusion Criteria

  • Have active Richter's transformation or need treatment for it.
  • Have conditions that prevent absorption of the study drug.
  • Have severe heart problems or recent heart attacks.
  • Have a low heart function or prolonged QT interval on an ECG.
  • Have had major surgery recently without full recovery.
  • Have active bleeding disorders or recent significant strokes.
  • Test positive for HIV, hepatitis B, or hepatitis C.
  • Have uncontrolled infections or other serious health conditions.
  • Have uncontrolled autoimmune blood disorders.
  • Have another active cancer unless in remission with a life expectancy over 2 years.
  • Require blood thinners like warfarin.
  • Have received live vaccines recently.
  • Have known allergies to the study drug or its components.

Locations

FACILITYZIPCITYSTATE
Ohio State University Comprehensive Cancer Center43210ColumbusOhio

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