IRB Number:

07-000789

Trial Status:

Open for Enrollment

Phase: III

Why is this study being done?

This study is being done to:
- Find out what effects (good and bad) the modification of the stem cell collection machine (apheresis machine) has on the collection of lymphocytes (the body immune cells that attack lymphoma).
- To see if collecting more lymphocytes by the new apheresis machine settings will or will not slow, decrease, or stop the growth of the patient's lymphoma.

Who is Eligible to Participate in the Study?

- Age 18 or older
- Diagnosed with any non-Hodgkin lymphoma type and is a candidate to proceed with autologous peripheral blood stem cell transplantation for non-Hodgkin lymphoma
- Four weeks since last chemotherapy (Rituxan is not considered chemotherapy for the purpose of this study)

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

What is Involved With this Study?

Patients that are candidates to proceed with autologous stem cell transplantation for lymphoma can participate in the study. They will have a physical examination, ECG
(electrocardiogram), blood tests (about 8-10 teaspoons of blood), urine test, chest x-ray, and other diagnostic x-rays and/or scans ordered by the doctor to learn about the patient's disease and if they are a candidate for autologous stem cell transplantation.

Randomization: If patient is a candidate to proceed for autologous stem cell transplantation and would like to participate in this study, they will be put in one of two
groups by chance (as in the flip of a coin). One group will collect their stem cells using the standard apheresis machine settings and the other group will collect their stem cells using the modified apheresis machine setting. Neither the patient nor their doctor will know which group the patient will be in. Enough stem cells will be collected to proceed with autologous stem cell transplantation if the patient is put in either of the two groups.

The following procedures and treatment will be the same for both groups and the only difference will be the settings on the stem cell machines used during collection:

Procedure for Stem Cell and lymphocyte Collection: Patients may have a catheter (tube)placed in a large vein to allow the removal of blood from their veins. They will have their
blood stem cells collected using a apheresis machine which is used to collect white blood cells (lymphocytes) and sometimes platelets. The purpose of this procedure is to harvest (collect) stem cells and lymphocytes to be reinfused at the same time of the patient's blood stem cell transplant.

For the procedure, patients will lay down on a bed for approximately 2 to 4 hours. Blood will leave the patient's body through one of the openings in their catheter and will
travel through the machine where part of the white blood cells will be removed, and then returned to their body through the second opening in their catheter.

Blood Stem Cell and Lymphocytes Processing and Storage: Great care will be taken in the processing, freezing, and storage of the patient's peripheral blood stem cells and
lymphocytes.

High-Dose Chemotherapy: After the collection process the patient will be admitted to the hospital to receive standard chemotherapy as determined by their doctor. After completing this treatment the patient's stored blood cells will be thawed and put back into their body by vein as a transfusion. G-CSF will be given once a day under the skin to help recovery of the patient's bone marrow until their white blood cell count recovers.

Required Tests and Follow-up: If choosing to participate in this research study, patients will have a physical examination, electrocardiogram (ECG, a recording of the heart's electrical activity), standard and research blood tests (approximately 8-10 teaspoons of blood), urine test, chest x-ray and other diagnostic x-rays, and/or scans ordered by the doctor to learn about the patient's disease.

A teaspoon of the stem cell collection and 4 teaspoons of blood for research studies will be collected at day 15, 3 months, 6 months, 9 months, and 12 months after the patient's transplant.

During treatment and for approximately 20 days after the blood stem cell transplant, patients will have three to six teaspoonfuls of blood also drawn daily to check
their blood counts, and the effect of treatment on their organ function.

At three, six, nine, and 12 months after completion of the transplant, and then every four months until two years from the time of starting this study, patients will have a physical examination, standard blood tests (4 to 6 teaspoons), CT-scans or MRI and other exams and procedures ordered by their doctor to evaluate their disease status. Patients may be asked to undergo a second bone marrow biopsy if there was lymphoma present in their past bone marrow.

How long will the Study run?

Patients will be in the study for two years after starting this study.

Sponsor(s): Mayo Clinic

Study Activation/Registration Date: 12/10/2007

IRB Review and Approval Date: 03/01/2007

Study Type: Treatment

Projected Accrual: The plan is to have up to 126 people take part in this study at Mayo Clinic.

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

Principal Investigator: L.F. Porrata, 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: 07/09/2008