Clinical trial NCT00904722
Conditions: Lymphoma
Keywords: Follicular lymphoma Immunotherapy CT-011 Monoclonal Antibody CT-011 Rituximab Rituxan
Sponsor: M.D. Anderson Cancer Center
Start date: 2010-01-01; Completion date: 2015-04-01
Enrollment: 32 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
The goal of this clinical research study is to learn if the combination of the immunotherapy drugs, CT-011 and rituximab, can help control follicular lymphoma. The safety of this drug combination will also be studied.

Detailed description:
The Study Drugs:

Rituximab is designed to attach to lymphoma cells, which may cause them to die.

CT-011 is designed to strengthen the immune system against cancer, possibly helping the immune cells kill the lymphoma cells better.

Study Drug Administration:

If you are found to be eligible to take part in this study, you will receive an infusion of CT-011 every 4 weeks for a total of 4 infusions. The first infusion will take at least 2 hours and will be given through a needle in your vein. Later infusions will take at least 1 hour. You must stay at the hospital for 2 hours after each infusion. If the lymphoma remains stable or is shrinking after 4 infusions of CT-011, you may receive 8 additional infusions of CT-011 every 4 weeks, for a total of 12 infusions.

You will receive rituximab as an infusion through a needle in your vein once a week for a total of 4 infusions. The first infusion of rituximab will begin about 17 days after the first infusion of CT-011. Each rituximab infusion will be given over 4-8 hours.

You will be watched carefully before, during, and after each CT-011 or rituximab infusion in case you experience any side effects to the drug. You will be given Benadryl (diphenhydramine) and Tylenol (acetaminophen) about 30 to 60 minutes before each infusion in order to lower the risk of possible side effects. If the doctor thinks it is needed, you may also be given other drugs such as hydrocortisone or prednisone (also known as corticosteroids) to help lower the risk of possible side effects. If the side effects become intolerable, and the doctor thinks it is necessary, the infusion may be stopped for a short time or stopped completely.

Study Visits:

The following tests will be performed at your scheduled study visits.

Within 30 days before the first infusion of study drug (up to 2 weeks after the screening tests are complete):

* Blood (about 4 ½ tablespoons) will be drawn for research tests designed to study the function of immune cells in your body.
* Up to 5 needle biopsies (mandatory) will be collected from an enlarged lymph node to collect tumor tissue for research tests. To collect needle biopsies, the area of the tumor is numbed with anesthetic, and a small amount of tumor tissue is withdrawn using a needle.

Blood (about 1 teaspoon each time) will be drawn for research tests to check the levels of CT-011 in the blood and measure how your immune system responds to the drug. These will be drawn right after and then 2 hours after each infusion of CT-011, and on Days 7, 24, 31, 38, and 43.

About 24 hours after the first CT-011 infusion:

-Blood (about 2 ½ tablespoons) will be drawn for research tests to learn if the study drug activates the immune cells.

Before the first rituximab infusion:

* Your medical history will be recorded.
* You will have a physical exam.
* You will have an ECG.
* Blood (about 1 tablespoon) will be drawn for routine tests.
* Blood (about 2 ½ tablespoons) will be drawn for research tests to learn if the study drug activates the immune cells longer than 2 weeks.

Before the second, third, and fourth CT-011 infusion:

* Your medical history will be recorded.
* You will have a physical exam.
* You will have an ECG.
* Blood (about 1 tablespoon) will be drawn for routine tests.
* Blood (about 2 ½ tablespoons) will be drawn for immune-response research tests.

Before the third CT-011 infusion:

* You will have x-rays and CT scans of the neck, chest, abdomen, and pelvis to check the disease status. You may also have a PET scan if your doctor thinks it is needed.
* If your bone marrow was affected by the lymphoma before starting this study, you will have 2 bone marrow biopsies and 1 bone marrow aspirate collected, to check the disease status.

About 4 weeks after the fourth infusion of CT-011:

* Your medical history will be recorded.
* You will have a physical exam.
* You will have an ECG.
* Blood (about 1 tablespoon) will be drawn for routine tests.
* You will have x-rays and CT scans of the neck, chest, abdomen, and pelvis to check the status of your lymphoma. You may also have a PET scan if your doctor thinks it is needed.
* If your bone marrow was affected by lymphoma before starting therapy, you will have 2 bone marrow biopsies and 1 bone marrow aspirate collected to check the status of the disease.
* Blood (about 2 ½ tablespoons) will be drawn for immune-response research studies.

Before CT-011 infusions 5 through 12:

* Your medical history will be recorded.
* You will have a physical exam.
* Blood (about 1 tablespoon) will be drawn for routine tests.

Length of Study:

You may continue receiving CT-011 for up to a total of 12 infusions. You will be taken off study if you have intolerable side effects or the disease gets worse.

Long-Term Follow-Up:

You will be asked to return to the clinic for the following long-term follow-up tests:

About every 3 months after you complete 4 infusions of CT-011:

* Your medical history will be recorded.
* You will have a physical exam.
* You will have an ECG at the final study completion visit.
* Blood (about 1 tablespoon) will be drawn for routine tests.
* You will have x-rays and CT scans of the neck, chest, abdomen, and pelvis to check the disease status.

If your CT scans show that the lymphoma has gone away completely during the above visits, you may also have a PET scan and 2 bone marrow biopsies and 1 bone marrow aspirate collected to confirm the disease status.

At 3, 6, 9, and 12 months after the end of treatment:

-Blood (about 2 ½ tablespoons each time) will be drawn for immune-response research studies.

This is an investigational study. Rituximab is FDA approved and commercially available for the treatment of non-Hodgkin's lymphomas, including follicular lymphoma.

CT-011 is not FDA approved or commercially available. At this time, this drug is being used in research only.

Up to 30 patients will take part in this study. All will be enrolled at MD Anderson.

Arms: arm 1: Combination of the immunotherapy drugs, CT-011 and rituximab.
Interventions: intervention 1: CT-011 intervention 2: Rituximab
Intervention descriptions: intervention 1: Administered intravenously at a dose of 3.0 mg/kg on days 1, 29 (+/- 7 days), 57 (+/- 7 days), and 85 (+/- 7 days). intervention 2: Administered intravenously at the standard dose of 375 mg/m\^2 weekly for 4 weeks on days 17 (+/- 1 day), 24 (+/- 1 day), 31 (+/- 1 day), and 38 (+/- 1 day).

Protocol documents: