IRB Number:

07-002428

Trial Status:

Open for Enrollment

Phase: II

Why is this study being done?

Patients are being asked to take part in this research study because they have follicular B-cell Non-Hodgkin lymphoma and have not had any chemotherapy or radiation treatment.
This research study is being done to find out what effects, good and/or bad, the drug denileukin diftitox combined with rituximab has on the patient and their follicular B-cell Non-Hodgkin lymphoma.

It is important to realize that while rituximab is frequently used as initial treatment for
this type of lymphoma, chemotherapy is also often used in combination with rituximab as
the first treatment for follicular lymphoma. Treatment with chemotherapy plus rituximab may result in more patients responding to treatment and for a longer time, but also in more side effects.

While doctors hope rituximab and denileukin diftitox will be more useful against cancer compared to rituximab alone or rituximab in combination with chemotherapy drugs, there is no proof of this yet.

Who is Eligible to Participate in the Study?

-Age 18 or older
-Diagnosed with follicular B-cell non-Hodgkin lymphoma and have not had any chemotherapy or radiation treatment.

*More specific, detailed eligibility and/ or exclusion criteria are associated with this trial.

What is Involved With this Study?

If agreeing to be in the study, patients will be asked to participate in the following:

Before beginning the study:
Before registering on the study, a sample of the patient's tumor tissue will be needed to confirm their diagnosis of follicular B-cell Non-Hodgkin lymphoma. The sample will
come from the patient's most recent biopsy, so they will not need to have an extra biopsy done. This is required to be a part of this study.

If the tests show that the patient can be in the study, and they choose to take part, then before treatment begins, patients will need the following tests and procedures. They are part of regular cancer care.
- Pregnancy test (for female patients only)
- Medical history
- Complete physical exam, including height and weight
- Tumor measurement.
- Blood tests. (About 8 teaspoons of blood will be drawn).
- CT scan (a test that uses computers and X-rays to take pictures of the body's organs)
- PET scan (computer pictures of the bloodstream)
- Bone marrow biopsy and fluid sample.

Patients will need these tests and procedures that are either being tested in this study or being done to see how the study is affecting the patient's body.
- Blood and/or tissue taken for research tests. This is required. (About 8 teaspoons of blood will be drawn for this).

During the study
Before getting each of the patient's rituximab treatments, the patient will be given acetaminophen by mouth and diphenhydramine either by mouth or through a vein in their arm (IV). These drugs will be given to avoid a general over-reaction to the study drugs. When the patient gets treatment with denileukin diftitox, they will also get dexamethasone either by mouth or IV, which will help control any reactions from taking the chemotherapy drugs. A cycle is three weeks. Patients will be given rituximab weekly for four weeks and denileukin diftitox for four cycles (12 weeks) on the following schedule.

- Rituximab: On Days 1, 8, 15, and 22 from the start of study, patients will be given rituximab through a vein in their arm. The patient's blood pressure will be monitored during the time they are getting rituximab.
- Denileukin diftitox: Every three weeks for four cycles (12 weeks), patients will get denileukin diftitox through a vein in their arm on Days 1-5. On the first day of Cycle 1 and Cycle 2, the denileukin diftitox and the rituximab will be given on the same day. The first dose of denileukin diftitox will take 40 to 60 minutes, but if there are no problems or reactions, the rest of the treatments may only take 15 minutes. Saline may also be given before the denileukin diftitox and after completing the infusion.

During the study, patients will need the following tests and procedures.
- Blood tests weekly while the patient is taking treatment. (About 1 teaspoon of blood will be drawn for this.)
- Tumor measurement
- Review of any side effects
- Blood draws taken for research. (About 8 teaspoons of blood will be drawn for this).
These tests are required.

When the patient is finished taking denileukin diftitox and rituximab:
After four cycles, the patient will stop getting chemotherapy, but they will still be followed by the study doctor and will have the following tests. Patients will be followed for up to five years.

One month after completing treatment:
-- Physical exam, including weight
-- Blood tests
-- Tumor measurement
-- Review of any bad side effects
-- CT scan
-- PET scan
- -- Blood draws taken for research (About 8 teaspoons of blood will be drawn for this).

At four, seven, and 10 months after completing treatment:
-- Physical exam, including weight
-- Blood tests
-- Tumor measurement
-- Review of any bad side effects
-- CT scan
-- Bone marrow biopsy and fluid to confirm response to treatment.
- -- Blood draws taken for research (only at four months) (About 8 teaspoons of blood will be drawn for this).

One year after completing treatment:
-- Physical exam, including weight
-- Blood tests
-- Tumor measurement
-- Review of any bad side effects
-- CT scan

Every six months for years 2-5;
-- Physical exam, including weight
-- Blood tests
-- Tumor measurement
-- CT scan

If the patient's disease gets worse, they will have the following tests and procedures until they begin some other therapy.
-- Physical exam, including weight
-- Blood tests
-- Tumor measurement
-- CT scan

The drugs used in this study are considered investigational, which means they have either not been approved by the U.S. Food and Drug Administration (FDA) for routine clinical use or for the use described in this study. However the FDA has allowed the use of these drugs in this research study.

How long will the Study run?

Patients will be in this study for up to five years.

Sponsor(s): North Central Cancer Treatment Group (NCCTG)

Study Activation/Registration Date: 04/07/2008

IRB Review and Approval Date: 03/28/2008

Study Type: Treatment

Projected Accrual: The plan is to enroll up to 53 patients to participate from multiple medical centers.

Costs of Study:There may be standard patient care costs related to participating in a cancer research study.

Principal Investigator: Stephen M. Ansell, MD

Who can I Contact for Additional Information on this Trial?

Complete Request Form for Cancer Clinical Trial Information at Mayo Clinic or
For more information about this study or other clinical trial options, please contact our Mayo Clinic Cancer Center Clinical Trials Referral Office.

• Patients living within the United States, call 507-538-7623, or e-mail cancerclinicaltrials@mayo.edu


• Patients living outside the United States may call our International Office at 507-284-8884, or e-mail intl.mcr@mayo.edu.

What is/are the Locations of this Clinical Trial?

• Rochester, MN

Last updated: 05/12/2008