Urelumab (CD137 mAb) With Rituximab for Relapsed, Refractory or High-risk Untreated Chronic Lymphocytic Leukemia (CLL) Patients

Leukemia Clinical Trial

Official title: Urelumab (CD137 mAb) Combined With Rituximab for Relapsed, Refractory or High-risk Untreated Patients With Chronic Lymphocytic Leukemia (CLL)/Small Lymphocytic Lymphoma (SLL)

Status Withdrawn

Clinical Trial Summary

The goal of this clinical research study is to learn if urelumab given in combination with rituximab can help to control CLL or SLL. The safety of the drug combination will also be studied.

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 over 4-6 hours on Days 1, 8, 15, 22, 43, and 64 of each 84 day (12 week) cycle.

You will receive urelumab by vein over about 1 hour on Days 2, 23, 44, and 65 of each cycle.

There will be a 2-week period between each study cycle.

Study Visits:

On Days 1, 8, 15, 22, 43, and 64 of each cycle:

• Blood (about 2 tablespoons) will be drawn for routine tests.

• You will have a physical exam.

On Days 2, 29, 36, 50, 57, 71, and 78 of each cycle, blood (about 2 tablespoons) will be drawn for routine tests.

At the end of each cycle (about Day 85):

• Blood (about 2 tablespoons) will be drawn for routine tests.

• You will have a physical exam.

• You will have a bone marrow aspiration and biopsy to check the status of the disease.

• You will have a CT or PET scan to check the status of the disease.

You will have blood draws, CT scans (or PET scans) and/or bone marrow aspiration and biopsies at any time that the doctor thinks it is needed while you are on study.

Length of Study:

You may receive up to 2 cycles of study drugs. However, your study doctor may allow you to receive the study drugs beyond Cycle 2. You will no longer be able to take the study drugs if the disease gets worse, if intolerable side effects occur, or if you are unable to follow study directions.

Your participation on the study will be over after the follow-up visits.

End-of-Study Visit:

If you are taken off study for any reason, the following tests and procedures will be performed:

• You will have a physical exam.

• Blood (about 2-3 tablespoons) will be drawn for routine tests.

• If the doctor thinks it is needed, you will have a bone marrow aspirate and CT or PET scan to check the status of the disease.

Long-Term Follow-Up:

After you are no longer on study, 1 time every month:

• You will have a physical exam.

• Blood (about 2-3 tablespoons) will be drawn for routine tests.

Every 3 months, if the doctor thinks it is needed, you will have a bone marrow aspirate and CT or PET scan to check the status of the disease.

Other Testing:

The study staff may ask you to take part in other MD Anderson clinical research study (PA13-0291) for additional research testing. The study doctor will discuss this with you and, if you decide to take part, you will sign a separate consent document.

This is an investigational study. Urelumab is not FDA approved or commercially available. Rituximab is FDA approved and commercially available for the treatment of patients with CLL. The use of these drugs in combination is investigational. The study doctor can explain how the drugs are designed to work.

Up to 24 participants will be enrolled in this study. All will take part at MD Anderson. ;

Study Design

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

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

• NCT number: NCT02420938
• Study type: Interventional
• Source: M.D. Anderson Cancer Center
• Status: Withdrawn
• Phase: Phase 2
• Start date: July 2015