Study on Ibrutinib for Treating Patients with Relapsed Hairy Cell Leukemia

Program Overview

This phase II study is investigating the effectiveness of ibrutinib in treating patients whose hairy cell leukemia (HCL) has come back after a period of improvement. The drug works by blocking enzymes that cancer cells need to grow. The study aims to see how well patients respond to the treatment, how long they can go without the disease getting worse, and how well they tolerate the drug.

Description

The main goal of this study is to find out how many patients with hairy cell leukemia (HCL) respond to ibrutinib treatment after 32 weeks. Researchers will look at both complete and partial responses to the drug.

Other goals include:

• Understanding the side effects and how well patients tolerate ibrutinib.
• Measuring how long patients live without the disease getting worse and their overall survival.
• Checking if the disease is completely undetectable in some patients after treatment.
• Studying how ibrutinib affects the immune system and certain markers in the blood and cancer cells.

Patients will take ibrutinib by mouth once a day in 28-day cycles. They may continue treatment for up to 8 cycles if there is no response, up to 12 cycles if there is no significant improvement, or longer if the doctor decides it's beneficial and there are no severe side effects. Patients will also have regular tests, including bone marrow biopsies, blood tests, and scans, to monitor their progress.

After finishing the treatment, patients will have follow-up visits every 3 months to check on their health and any long-term effects of the treatment.

Eligibility Criteria

Locations