Phase 2 Study of the Combination of Bruton's Tyrosine Kinase Inhibitor PCI-32765 and Rituximab in High-Risk Chronic Lymphocytic Leukemia and Small Lymphocytic Lymphoma Patients

Leukemia Clinical Trial

Official title: A Phase 2 Study of the Combination of the Bruton's Tyrosine Kinase Inhibitor PCI-32765 and Rituximab in High-Risk Chronic Lymphocytic Leukemia (CLL) and Small Lymphocytic Lymphoma (SLL) Patients

Status Completed

Clinical Trial Summary

The goal of this clinical research study is to learn if PCI-32765 (Ibrutinib) combined with rituximab can help to control CLL and SLL. The safety of this combination will also be studied.

Ibrutinib is designed to stop a protein from working in the cells, which may cause the cancer cells to die or stop growing.

Rituximab is designed to attach to cancer cells and damage them, which may cause the cells to die.

Clinical Trial Description

Study Drug Administration:

If you are found to be eligible to take part in this study, you will receive rituximab by vein on Days 1, 8, 15, and 22 of Cycle 1 (+ 3 days) and then on Day 1 (+/- 7 days) of Cycles 2-6.

Each cycle is 28 days.

You will take Ibrutinib capsules by mouth 1 time each day starting on Day 2 of Cycle 1. You should take it with 1 cup (8 ounces) of water.

You will also take allopurinol by mouth 1 time each day during the first 1-2 weeks of study treatment to lower the risk of side effects.

Study Visits:

On Days 7, 14, 21, and 28 of Cycle 1 (+/- 3 days):

• You will have a physical exam, including measurement of your vital signs.

• Blood (about 1 tablespoon) will be drawn for routine tests.

• You will be asked about any drugs you may be taking.

At the end of Cycles 2, 3, 4, 6, 9, and 12 (+/- 1 month):

• You will have a physical exam, including measurement of your vital signs.

• Blood (about 1 tablespoon) will be drawn for routine tests.

• You will be asked about any drugs you may be taking.

At the end of Cycles 3 or 6, and 12 (+/- 1 month), and then every 12 cycles (+/- 1 month) after that if the doctor thinks it is needed, you will have CT scans of the chest, abdomen and pelvis to check the status of the disease.

At the end of Cycles 3, 6, and 12 and then every 12 cycles (+/- 1 month) after that, you will have a bone marrow aspiration to check the status of the disease. If the doctor things these bone marrow aspirations are no longer needed, you will no longer have to have them.

Every 3 months (+/- 1 month) for Cycles 13-36 and every 6 months (+/- 1 month) after that:

• You will have a physical exam, including measurement of your vital signs.

• Blood (about 1 tablespoon) will be drawn for routine tests.

• You will be asked about any drugs you may be taking.

Length of Treatment:

You may continue taking the study drug combination of rituximab and Ibrutinib for up to 6 cycles, after which Ibrutinib will be continued for up to a total of 12 cycles. It will be possible to continue with Ibrutinib treatment beyond 12 cycles if the study doctor thinks it is in your best interest. You will no longer be able to take the study drug if the disease gets worse, if intolerable side effects occur, or if you are unable to follow study directions.

This is an investigational study. Ibrutinib is FDA approved and commercially available for the treatment of patients with mantle cell lymphoma, CLL and SLL. Its use in this study is investigational. Rituximab is FDA approved to treat CLL and SLL.

Up to 40 patients will take part in this study. All will be enrolled at MD Anderson. ;

Related Conditions & MeSH terms

• Leukemia
• Leukemia, Lymphocytic, Chronic, B-Cell
• Leukemia, Lymphoid
• Lymphoma

• NCT number: NCT01520519
• Study type: Interventional
• Source: M.D. Anderson Cancer Center
• Status: Completed
• Phase: Phase 2
• Start date: February 27, 2012
• Completion date: August 9, 2018