Immunotherapy With NK Cell, Rituximab and Rhu-GMCSF in Non-Myeloablative Allogeneic Stem Cell Transplantation
Rituximab is designed to attach to lymphoma cells, causing them to die. GM-CSF and NK cells
may increase rituximab's ability to kill these cells.
Before you can start treatment on this study, you will have what are called "screening
tests." These tests will help the doctor decide if you are eligible to take part in this
study. You will have your complete medical history recorded and a physical exam. Your blood
(about 2 tablespoons) will be collected for routine tests. A bone marrow aspirate will be
performed. To collect a bone marrow aspirate, an area of the hip or chest bone is numbed
with anesthetic and a small amount of bone marrow is withdrawn through a large needle. You
will have computerized tomography (CT) scans as well as positron emission tomography (PET)
or gallium scans to learn the status of your disease. Women who are able to have children
must have a negative blood or urine pregnancy test.
If you are found eligible to take part in this study, you will receive treatment as an
outpatient. You will receive GM-CSF 3 times a week for 4 weeks through a vein, starting the
day before you receive the administration of rituximab. You will receive rituximab over 4 to
8 hours through a vein, once weekly for 4 weeks. You will also get a boost of NK cells from
the same donor from whom you received your original transplant. These cells will be infused
through a vein (over 30 to 60 minutes) after the 4th dose of rituximab. If you are
receiving a cell infusion from somebody who you are not related to, the infusion may have to
be done later if cells were not available as scheduled.
The CliniMACS System is a medical device that is used to separate types of blood cells from
blood that is removed from the body during leukapheresis. These separated cells are
processed for use in treatments such as stem cell transplants.
During this treatment, you will be examined as needed, and blood samples (1 tablespoon once
or twice a week) will be taken for routine tests. You may need to receive blood
transfusions during this study if your blood cell counts remain low.
You may be taken off this study if your disease gets worse or intolerable side effects
You will have long-term, follow-up visits while on study. You will be seen at 4 to 6 weeks
after you receive NK cell infusion; every 3 months during the first year; and then once a
year. During each of these visits, you will have CT and PET scans, a bone marrow biopsy, and
blood drawn (about 4 teaspoons) to learn the status of your disease.
This is an investigational study. Rituximab and GM-CSF are FDA approved and commercially
available. NK cells are authorized by the FDA for use in research only. Up to 40
participants will take part in this study. All will be enrolled at M. D. Anderson.
The CliniMACS device is not FDA approved. At this time, it is being used in research only.
Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Dose-limiting toxicities (DLTs) for NK cells infusions after non-myeloablative transplantation for lymphoid malignancies
Evaluated for toxicity within 6 weeks of treatment
Issa F. Khouri, MD
M.D. Anderson Cancer Center
United States: Food and Drug Administration
|UT MD Anderson Cancer Center||Houston, Texas 77030|