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

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborator:
Information provided by (Responsible Party):
Robert Negrin, Stanford University
ClinicalTrials.gov Identifier:
NCT00185757
First received: September 12, 2005
Last updated: December 13, 2012
Last verified: December 2012
  Purpose

The purpose of the study is to determine if the use of activated T cells can effectively treat relapsed disease following allogeneic hematopoietic cell transplantation without causing GVHD.


Condition Intervention Phase
Multiple Myeloma
Blood and Marrow Transplant (BMT)
Drug: Cytokine Induced Killer Cells
Phase 1

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Cytokine Induced Killer Cells as Post-Transplant Immunotherapy Following Allogeneic Hematopoietic Cell Transplantation

Resource links provided by NLM:


Further study details as provided by Stanford University:

Primary Outcome Measures:
  • To determine the feasibility of expanding allogeneic cytokine induced killer cells suitable for clinical application using a continuous perfusion culture system. [ Time Frame: 21 to 28days before infusion ] [ Designated as safety issue: Yes ]
  • To determine the infusional toxicity of ex vivo expanded allogeneic CIK cells in patients with recurrent or refractory disease following allogeneic hematopoietic cell transplantation. [ Time Frame: day of infusion up to 24 hours after infusion ] [ Designated as safety issue: Yes ]
  • To determine the incidence of Graft-versus-Host Disease (GVHD) following infusion of allogeneic CIK cells. [ Time Frame: first 100 days after infusion ] [ Designated as safety issue: Yes ]
  • To determine the maximum tolerated dose (MTD) of expanded CIK cells for infusion. [ Time Frame: day plus 100 after infusion ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • o determine the incidence of disease response following treatment with allogeneic CIK cells. [ Time Frame: one year ] [ Designated as safety issue: No ]
  • To assess donor-specific chimerism before and after treatment with allogeneic CIK cells. [ Time Frame: 3 months ] [ Designated as safety issue: No ]
  • To optimize the ex vivo expansion of CIK cells using a continuous perfusion culture system. [ Time Frame: 21-28 days ] [ Designated as safety issue: No ]

Estimated Enrollment: 20
Study Start Date: June 2004
Estimated Study Completion Date: December 2012
Estimated Primary Completion Date: December 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Cytokine-induced Killer Cells
The first cohort =1X10 7 cf expanded cells/kg. The second cohort = 5x10 7 expanded cells/kg. The second cohort = 1X10 8 expanded cells/kg.
Drug: Cytokine Induced Killer Cells
CIK cell dose escalation will be performed in cohorts of three patients per group. The initial dose utilized will be 1x107 expanded cells/kg. Previously, unmanipulated donor lymphocytes administered at this dose did not result in significant GVHD 7. The expansion of the CIK cell population is expected to diminish the T cell subsets responsible for GVHD further reducing the risk of GVHD to recipients. The dose will be increased to 5x107 expanded cells/kg and 1x108 expanded cells/kg in successive escalations based on no significant infusional toxicity or GVHD in the recipients

  Eligibility

Ages Eligible for Study:   18 Years to 75 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:- Evidence of recurrent or persistent hematologic malignancy following HLA matched allogeneic hematopoietic cell transplant

  • eligible for DLI
  • no evidence of GVHD
  • stable immunosuppressive regimen
  • adequate renal and liver function

Exclusion Criteria:- CML patients who have not received DLI, active infections

  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00185757

Locations
United States, California
Stanford University School of Medicine
Stanford, California, United States, 94305
Sponsors and Collaborators
Robert Negrin
Investigators
Principal Investigator: Robert S Negrin Stanford University
  More Information

No publications provided

Responsible Party: Robert Negrin, Professor of Medicine, Stanford University
ClinicalTrials.gov Identifier: NCT00185757     History of Changes
Other Study ID Numbers: BMT162, 95070, BMT162, 13644
Study First Received: September 12, 2005
Last Updated: December 13, 2012
Health Authority: United States: Institutional Review Board
United States: Food and Drug Administration

Additional relevant MeSH terms:
Multiple Myeloma
Neoplasms, Plasma Cell
Neoplasms by Histologic Type
Neoplasms
Hemostatic Disorders
Vascular Diseases
Cardiovascular Diseases
Paraproteinemias
Blood Protein Disorders
Hematologic Diseases
Hemorrhagic Disorders
Lymphoproliferative Disorders
Immunoproliferative Disorders
Immune System Diseases

ClinicalTrials.gov processed this record on October 19, 2014