Study on Intermittent Duvelisib Dosing for Treating Chronic Lymphocytic Leukemia or Small Lymphocytic Lymphoma

Sponsor: City of Hope Medical Center

Sponsor score: 40

ClinicalTrials ID:NCT03961672

This clinical trial is testing how well the drug duvelisib works when given on an irregular schedule to treat patients with chronic lymphocytic leukemia or small lymphocytic lymphoma. The study aims to see if this approach can effectively stop cancer growth with fewer severe side effects.

Patient Parameters

Parameter	Options

Program Overview

This phase II study is exploring the effectiveness of duvelisib, a drug that may block cancer cell growth, in patients with chronic lymphocytic leukemia (CLL) or small lymphocytic lymphoma (SLL). The trial is testing an intermittent dosing schedule to see if it can provide similar benefits with fewer side effects. Patients will receive duvelisib in cycles, with an initial intensive phase followed by a maintenance phase with less frequent dosing. The study will monitor how long patients remain free from disease progression and assess the safety and benefits of the treatment.

Description

The main goal of this study is to evaluate how well duvelisib works in patients with relapsed or hard-to-treat chronic lymphocytic leukemia (CLL) by measuring how long they can go without the disease getting worse. The study also aims to assess the safety of duvelisib and any clinical benefits it may provide.

During the initial phase, called induction, patients will take duvelisib by mouth twice a day for 28 days, repeating this cycle for 12 weeks unless the disease progresses or side effects become too severe. In the maintenance phase, patients will take duvelisib twice a day on specific days of each 28-day cycle, continuing as long as the treatment is effective and tolerable.

After finishing the study treatment, patients will have follow-up visits every three months for up to a year to monitor their health and any changes in their condition.

Eligibility Criteria

Inclusion Criteria

Must understand and agree to sign a consent form.
Have a confirmed diagnosis of chronic lymphocytic leukemia (CLL) or small lymphocytic lymphoma (SLL).
Have previously received at least one treatment for CLL/SLL and either did not respond or the disease came back.
Show active disease that meets specific criteria for needing treatment, such as significant weight loss, extreme fatigue, fever, night sweats, worsening anemia, or enlarged lymph nodes.
Be in good general health with a performance status of 0 to 2, meaning fully active or able to carry out light work.
Have adequate liver and kidney function as shown by specific blood tests.
Have sufficient blood cell counts, including platelets and neutrophils.
Be able to swallow pills.
Women of childbearing potential must have a negative pregnancy test and agree to use effective birth control during and after the study.
Men must agree to use effective birth control during and after the study.

Exclusion Criteria

Have received certain cancer treatments recently, such as specific antibodies, radiation, or targeted therapies.
Have not recovered from side effects of previous treatments.
Use high doses of corticosteroids regularly.
Have had a stem cell transplant in the past year or are on certain immunosuppressive medications.
Take medications that strongly affect liver enzymes.
Cannot take preventive treatments for certain infections.
Have a history of other cancers unless treated and inactive for at least two years.
Have uncontrolled immune-related blood disorders.
Have active infections like HIV or hepatitis.
Have chronic liver disease.
Have had major surgery recently.
Have conditions affecting drug absorption.
Have had recent heart problems or abnormal heart rhythms.
Have an active, uncontrolled infection.
Have mental health or social issues that would prevent following the study requirements.
Are pregnant, breastfeeding, or planning to have children during the study and for a period after.

Locations

FACILITY	ZIP	CITY	STATE
City of Hope Medical Center	91010	Duarte	California
Dana-Farber Cancer Institute	02215	Boston	Massachusetts
OHSU Knight Cancer Institute	97239	Portland	Oregon

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