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Immunotherapy With NK Cell, Rituximab and Rhu-GMCSF in Non-Myeloablative Allogeneic Stem Cell Transplantation
This study is currently recruiting participants.
Verified by M.D. Anderson Cancer Center, November 2008
First Received: October 2, 2006   Last Updated: November 13, 2008   History of Changes
Sponsors and Collaborators: M.D. Anderson Cancer Center
Bayer Healthcare Pharmaceuticals, Inc./Bayer Schering Pharma
Information provided by: M.D. Anderson Cancer Center
ClinicalTrials.gov Identifier: NCT00383994
  Purpose

Primary Objectives:

  1. To determine the safety of Natural Killer (NK) cells and Rituximab + rhu-GMCSF in patients with persistent or recurrent B-cell lymphoid malignancies after non-myeloablative stem cell transplantation.
  2. To determine factors associated with response.

Condition Intervention
Lymphoma
Leukemia
Stem Cell Transplantation
Drug: GM-CSF
Drug: Rituximab
Biological: NK Cell Infusion

MedlinePlus related topics: Cancer Leukemia, Adult Acute Leukemia, Adult Chronic Leukemia, Childhood Lymphoma
Drug Information available for: Granulocyte-macrophage colony-stimulating factor Sargramostim Rituximab
U.S. FDA Resources
Study Type: Interventional
Study Design: Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Safety/Efficacy Study
Official Title: Immunotherapy With NK Cell, Rituximab and Rhu-GMCSF in Non-Myeloablative Allogeneic Stem Cell Transplantation

Further study details as provided by M.D. Anderson Cancer Center:

Primary Outcome Measures:
  • To find if giving a boost of natural killer (NK) cells from a donor, combined with Rituxan (rituximab), can help to control disease in patients who have already received an allogeneic stem cell transplant. [ Time Frame: 4 Years ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 40
Study Start Date: September 2006
Estimated Primary Completion Date: September 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
1: Experimental
Immunotherapy in Non-myeloablative Allogeneic Stem Cell Transplantation
Drug: GM-CSF
250 micrograms subcutaneously 3 times a week for 4 weeks starting a day before the administration of Rituximab.
Drug: Rituximab
375 mg/m^2 followed by 1000 mg/m^2 weekly for 3 weeks for a total of 4 doses.
Biological: NK Cell Infusion
NK cells will be infused one week after the fourth dose of Rituximab and GM-CSF.

Detailed Description:

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.

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 occur.

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.

  Eligibility

Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

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

  • Pregnancy or lactation
  • HIV , HTLV-I or hepatitis.
  • Active infection(s) >/= grade 3.
  • Severe active concomitant medical or psychiatric illness.
  • Concurrent active GVHD requiring tacrolimus
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00383994

Contacts
Contact: Issa F. Khouri, MD 713-745-2803

Locations
United States, Texas
U.T.M.D. Anderson Cancer Center Recruiting
Houston, Texas, United States, 77030
Principal Investigator: Issa F. Khouri, MD            
Sponsors and Collaborators
M.D. Anderson Cancer Center
Bayer Healthcare Pharmaceuticals, Inc./Bayer Schering Pharma
Investigators
Principal Investigator: Issa F. Khouri, MD U.T.M.D. Anderson Cancer Center
  More Information

Additional Information:
No publications provided

Responsible Party: U.T.M.D. Anderson Cancer Center ( Issa F. Khouri, MD/Professor )
Study ID Numbers: 2005-0234
Study First Received: October 2, 2006
Last Updated: November 13, 2008
ClinicalTrials.gov Identifier: NCT00383994     History of Changes
Health Authority: United States: Food and Drug Administration

Keywords provided by M.D. Anderson Cancer Center:
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

Study placed in the following topic categories:
Leukemia, Lymphoid
Immunoproliferative Disorders
Immunologic Factors
Rituximab
Lymphoma, B-Cell
Lymphoma, Small Cleaved-cell, Diffuse
Leukemia
Lymphatic Diseases
Chronic Lymphocytic Leukemia
B-cell Lymphomas
Leukemia, Lymphocytic, Chronic, B-Cell
Antirheumatic Agents
Lymphoma, Non-Hodgkin
Lymphoproliferative Disorders
Leukemia, B-cell, Chronic
Lymphoma

Additional relevant MeSH terms:
Neoplasms by Histologic Type
Immunoproliferative Disorders
Immune System Diseases
Immunologic Factors
Antineoplastic Agents
Rituximab
Physiological Effects of Drugs
Pharmacologic Actions
Leukemia
Lymphatic Diseases
Neoplasms
Therapeutic Uses
Lymphoproliferative Disorders
Antirheumatic Agents
Lymphoma

ClinicalTrials.gov processed this record on May 07, 2009