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Immunotherapy With NK Cell, Rituximab and Rhu-GMCSF in Non-Myeloablative Allogeneic Stem Cell Transplantation

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Lymphoma, Leukemia, Stem Cell Transplantation

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Trial Information

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with anesthetic and a small amount of bone marrow is withdrawn through a large needle.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.

Inclusion Criteria:

1. Patients with previous diagnosis of CD20+ B-cell CLL and non-Hodgkin's lymphoma who
have failed standard conventional chemotherapy, and who had persistent disease at 3
months, or progressive disease after non-myeloablative allogeneic transplantation.

2. Donor willingness to donate peripheral blood (same donor of the original transplant).

3. Negative Beta HCG in a woman with child bearing potential defined as not
post-menopausal for 12 months or not previous surgical sterilization.

Exclusion Criteria:

1. Pregnancy or lactation

2. HIV , HTLV-I or hepatitis.

3. Active infection(s) >/= grade 3.

4. Severe active concomitant medical or psychiatric illness.

5. Concurrent active GVHD requiring tacrolimus

Type of Study:


Study Design:

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

Outcome Measure:

Dose-limiting toxicities (DLTs) for NK cells infusions after non-myeloablative transplantation for lymphoid malignancies

Outcome Time Frame:

Evaluated for toxicity within 6 weeks of treatment

Safety Issue:


Principal Investigator

Issa F. Khouri, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

M.D. Anderson Cancer Center


United States: Food and Drug Administration

Study ID:




Start Date:

September 2006

Completion Date:

Related Keywords:

  • Lymphoma
  • Leukemia
  • Stem Cell Transplantation
  • Chronic Lymphocytic Leukemia
  • CLL
  • Non-Hodgkin's Lymphoma
  • B-Cell Lymphoma
  • Lymphoma
  • Leukemia
  • NK Cells
  • Rituximab
  • GM-CSF
  • Non-myeloablative Allogeneic Stem Cell Transplantation
  • Stem Cell Transplant
  • Leukemia
  • Lymphoma



UT MD Anderson Cancer Center Houston, Texas  77030