Study on Ibrutinib for Treating Patients with Relapsed or Hard-to-Treat Chronic Lymphocytic Leukemia, Small Lymphocytic Lymphoma, or B-cell Prolymphocytic Leukemia

Sponsor: Kami Maddocks, MD

Sponsor score: 0

ClinicalTrials ID:NCT01589302

This clinical trial is testing the effectiveness of a drug called Ibrutinib in patients whose chronic lymphocytic leukemia (CLL), small lymphocytic lymphoma (SLL), or B-cell prolymphocytic leukemia (B-PLL) has returned or not responded to previous treatments.

Patient Parameters

Parameter	Options

Program Overview

This study is exploring the use of an experimental drug called Ibrutinib, which is a type of medication known as a kinase inhibitor. Kinases are proteins that help cells grow, and this drug aims to block a specific kinase that helps blood cancer cells survive. By blocking this kinase, Ibrutinib may help kill cancer cells or stop them from growing. The trial is focused on patients with chronic lymphocytic leukemia (CLL), small lymphocytic lymphoma (SLL), or B-cell prolymphocytic leukemia (B-PLL) that has not responded to or has come back after standard treatments. Researchers are studying how well Ibrutinib works in treating these conditions and what effects it has on patients and their cancers.

Description

This clinical trial involves using an investigational drug called Ibrutinib, which is designed to block certain proteins that help cancer cells grow. The study is for patients with chronic lymphocytic leukemia (CLL), small lymphocytic lymphoma (SLL), or B-cell prolymphocytic leukemia (B-PLL) that has either returned after treatment or has not responded to previous therapies. The goal is to see how effective Ibrutinib is in treating these blood cancers and to understand the positive and negative effects it may have on patients. Participants will receive Ibrutinib and be monitored for changes in their cancer and overall health.

Eligibility Criteria

Inclusion Criteria

Have a confirmed diagnosis of relapsed or hard-to-treat chronic lymphocytic leukemia (CLL), small lymphocytic lymphoma (SLL), or B-cell prolymphocytic leukemia (B-PLL) that requires treatment and has not responded to at least one previous therapy.
Have results from specific genetic tests done before starting the study.
Be in relatively good health with a performance status score of 0 to 2, meaning fully active or restricted in physically strenuous activity but ambulatory.
Have a life expectancy of more than 2 months.
Have certain blood test results within specified limits, including bilirubin, liver enzymes, creatinine, neutrophil count, and platelet count.
Agree to use contraception during the study and for 30 days after the last dose if sexually active and able to have children.
Be able to understand and willing to sign a written informed consent document.
Have controlled infections if receiving extended antibiotics or preventive therapy.

Exclusion Criteria

Have received chemotherapy, radiotherapy, or immunotherapy within 4 weeks before the first dose of the study drug, except for certain corticosteroids.
Have not recovered from severe side effects of previous treatments given more than 4 weeks ago.
Are currently receiving other investigational drugs.
Have participated in any previous Ibrutinib clinical trial.
Have another cancer that limits survival to less than two years.
Have conditions affecting the digestive system, such as malabsorption syndrome or inflammatory bowel disease.
Require blood thinners like warfarin or heparin.
Have significant liver impairment or require treatment with certain strong medications.
Have serious medical conditions that could affect safety or the study's outcomes.
Have significant heart disease or recent heart attack.
Have active central nervous system involvement by lymphoma.
Are pregnant or breastfeeding.

Locations

FACILITY	ZIP	CITY	STATE
Ohio State University Medical Center	43210	Columbus	Ohio

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