Text Size

Prophylactic Transfer of Leukemia-reactive T Cells After Allogeneic Transplantation

This study is currently recruiting participants.
Verified June 2012 by University Hospital Carl Gustav Carus
Sponsor:
Information provided by (Responsible Party):
University Hospital Carl Gustav Carus
ClinicalTrials.gov Identifier:
NCT00460629
First received: April 12, 2007
Last updated: June 25, 2012
Last verified: June 2012
History of Changes
  Purpose

Efforts to decrease the risk of GvHD by depleting T cells from the graft in CML patients have been complicated by an increased incidence of leukemia-relapse. Newer protocols using CD34+ selected hematopoietic cells from matched-sibling donors and subsequent infusion of T cells in incremental doses to treat or avoid relapse of disease seem to be more promising. In this study, we try to further optimize this approach by the prophylactic infusion of cytotoxic T cells activated ex-vivo against leukemia-associated/specific antigens using peptide-pulsed dendritic cells.


Condition Intervention Phase
Chronic Myeloid Leukemia
 Procedure: Application of activated donor T cells
 Phase 1
Phase 2

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: Specific Cellular Immunotherapy in Patients With Chronic Myeloid Leukemia After Allogeneic Stem Cell Transplantation

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by University Hospital Carl Gustav Carus:

Primary Outcome Measures:
  • Feasibility of the infusion of in-vitro activated donor T cells [ Time Frame: 5 years ] [ Designated as safety issue: Yes ]
  • kinetic of BCR-ABL load after transplantation [ Time Frame: 5 years ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Rate of acute and chronic GvHD [ Time Frame: 3 years ] [ Designated as safety issue: Yes ]
  • Rate of infectious complications [ Time Frame: 2 years ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 20
Study Start Date: March 2005
Primary Completion Date: December 2011 (Final data collection date for primary outcome measure)
Intervention Details:
    Procedure: Application of activated donor T cells
    Ex-vivo generated donor T cells stimulated by antigen presenting cells loaded with peptides derived from leukemia-associated antigens
Detailed Description:

The conditioning protocol contains:

Total Body Irradiation 8-12 Gy (4-6 x 2 Gy, a 2 x/die) day -9 to-7 Thiotepa 10 mg/kg (2 x 5 mg/kg) day -5 Fludarabine 200 mg/m2 (5 x 40 mg/m2) day -6 to-2 ATG Fresenius 25 mg/kg (5 x 5 mg/kg) day -6 to-2 Cyclosporine A 1 mg/kg Day -10 to-3

on day 0 CD34+ cells after immunomagnetic selection are infused. > 4 x 10e6/kg CD34 cells/kg are required.

On days 28, 56 and 112 after transplantation, cytotoxic T cells generated in-vitro are infused in patients who do not have signs of acute GvHD.

Regular follow-up compromises immune monitoring including Tetramer analyses of Peptide-reactive T cells

  Eligibility

Ages Eligible for Study:   18 Years to 60 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • age 18-60
  • Ph+ CML
  • HLA A0201, 0301, 1101, B0801
  • BCR-ABL b3a2 positive
  • no significant comorbidities
  • resistance or intolerance of imatinib

Exclusion Criteria:

  • HIV positive
  • blast crisis
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00460629

Contacts
Contact: Martin Bornhäuser, MD +49351458 ext 4704 martin.bornhaeuser@uniklinikum-dresden.de

Locations
Germany
Medizinische Klinik und Poliklinik I Recruiting
Dresden, Germany, 01307
Sponsors and Collaborators
University Hospital Carl Gustav Carus
Investigators
Principal Investigator: Martin Bornhäuser, MD Medical Clinic, University Hospital Dresden
  More Information

Publications:

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Responsible Party: University Hospital Carl Gustav Carus
ClinicalTrials.gov Identifier: NCT00460629     History of Changes
Other Study ID Numbers: EK126092000
Study First Received: April 12, 2007
Last Updated: June 25, 2012
Health Authority: Germany: Federal Institute for Drugs and Medical Devices

Keywords provided by University Hospital Carl Gustav Carus:
Adoptive immunotherapy
BCR-ABL reactive T cells
Allogeneic Transplantation

Additional relevant MeSH terms:
Leukemia
Leukemia, Myeloid
Leukemia, Myelogenous, Chronic, BCR-ABL Positive
Neoplasms by Histologic Type
 Neoplasms
Myeloproliferative Disorders
Bone Marrow Diseases
Hematologic Diseases

ClinicalTrials.gov processed this record on May 19, 2013