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Robert Negrin

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Cytokine Induced Killer Cells as Post-Transplant Immunotherapy Following Allogeneic Hematopoietic Cell Transplantation

Contact Information

Stanford University School of Medicine 300 Pasteur Drive Stanford, CA 94305

Primary Contact:

BMT Referrals (650) 723-0822
To view all clinical trials at Stanford, please see the Clinical Trials Directory.

Brief

To determine if the use of activated T cells can effectively treat relapsed disease following allogeneic hematopoietic cell transplantation without causing GVHD.

Recruiting Status:

Recruiting

Stanford Recruiting Status:

Recruiting

Condition(s):

Intervention(s):

  • Gene Transfer: infusion of activated T cells

Phase:

Phase 1

Eligibility

Ages Eligible for Study:

18 years to 75 years

Genders Eligible for Study:

Male and Female

Health of Volunteers:

People with the conditions listed in this trial can participate as controls.

Key Inclusion Criteria:

? Patients must be between 18 and 75 years of age, inclusive.
? Patients must have undergone an HLA matched allogeneic transplant for hematologic malignancy other than CML who have recurrent or persistent disease and are otherwise eligible for donor leukocyte infusions. CML patients with persistent disease after receiving donor lymphocyte infusion of at least 1x10^8 cells/kg will be eligible for CIK cell therapy.
? Patients must have no evidence of active graft-versus-host disease and must be on a stable immunosuppressive regimen.
? Patients must not have any active infections.
? Patients must have a performance status of >70% on the Karnofsky scale (see Appendix A).
? Patients must have adequate renal function with a serum creatinine of < 2 mg/dl or creatinine clearance of > 50 cc/min.
? Patients must have adequate liver function with a direct bilirubin of <3 mg/dl or transaminases <3 times the upper limit of normal.
? Patients must have negative antibody serology for the human immunodeficiency virus (HIV1 and 2) and hepatitis C virus and negative test for hepatitis B surface antigen.
? Patients must have no psychosocial trait which would compromise their ability to comply with the prescribed treatment protocol.
? Patients must sign informed consent prior to initiation of any study-related treatments.

Donor Inclusion:
? Donors must be an HLA matched sibling.
? Donors must be 18-75 years of age, inclusive.
? Donors must be in a state of general good health and must be free of minor illnesses.
? Donors must have a white blood cell count >3.5x10^9/liter, platelets >150x10^9/liter and hematocrit >35%.
? Donors must be capable of undergoing leukapheresis.
? Donors must be able to understand and sign informed consent.

Key Exclusion Criteria:

? Diagnosis of CML except patients who have failed prior donor leukocyte infusion with a minimum cell dose of 1x10^8 cells/kg.
? Patients who have been diagnosed with a second cancer (except carcinoma in situ of the cervix and basal cell carcinoma of the skin) which is currently active or has been treated within three years prior to screening.

Donor exlusion:
? Donors must not be seropositive for HIV 1 and 2, Hepatitis B surface antigen, Hepatitis B Core antibody, Hepatitis C Antibody, HTLV antibody, CMV IgM, or RPR (Treponema).
? Female donors must not be pregnant or lactating and should be willing to use an acceptable form of birth control prior to apheresis.
? Donors must not have psychological traits or psychological or medical conditions which make them unlikely to tolerate the procedure.

Additional Study Details

Official Title:

Cytokine Induced Killer Cells as Post-Transplant Immunotherapy Following Allogeneic Hematopoietic Cell Transplantation

Anticipated start date:

6/8/2004

Lead Sponsor:

NIH

Investigator(s):

Study Type:

Interventional

Purpose:

Treatment

Allocation:

Non-randomized

Masking:

Open

Control:

none

Assignment:

Single Group

Endpoints:

Safety/Efficacy

Primary Outcomes:

  • 1. To determine the feasibility of expanding allogeneic cytokine induced killer cells suitable for clinical application using a continuous perfusion culture system.
  • 2. To determine the infusional toxicity of ex vivo expanded allogeneic CIK cells in patients with recurrent or refractory disease following allogeneic hematopoietic cell transplantation.
  • 3. To determine the incidence of Graft-versus-Host Disease (GVHD) following infusion of allogeneic CIK cells.
  • 4. To determine the maximum tolerated dose (MTD) of expanded CIK cells for infusion.

Secondary Outcomes:

  • 1. To determine the incidence of disease response following treatment with allogeneic CIK cells.
  • 2. To assess donor-specific chimerism before and after treatment with allogeneic CIK cells.
  • 3. To optimize the ex vivo expansion of CIK cells using a continuous perfusion culture system.

Total Number to be Enrolled:

20

Total Number to be Enrolled at Stanford:

20

More Information

Trial Unique Id: BMT162

Secondary ID(s):

  • BMT162
  • NCT00185757

Locations & Contacts

Stanford Locations & Contacts:

Stanford University School of Medicine 300 Pasteur Drive Stanford, CA 94305

Primary Contact:

BMT Referrals (650) 723-0822

Non-Stanford Locations:

The Stanford website does not have any locations outside of Stanford listed for this trial. You may want to check clinicaltrials.gov for posible additional locations.

This listing was last updated:

8/18/2009

PLEASE NOTE:

Study Coordinators and Research Nurses cannot give medical advice over the phone. Telephone numbers are provided for obtaining additional information on specific clinical research trials only. If you have specific questions which require clinical expertise, please call your primary care physician. If you do not have a primary care physician please feel free to call the SHC Physician Referral Service at (800) 756-9000 or send an email.

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