Prophylactic Transfer of Leukemia-reactive T Cells After Allogeneic Transplantation

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00460629
Recruitment Status : Completed
First Posted : April 16, 2007
Last Update Posted : June 20, 2013
Information provided by (Responsible Party):
University Hospital Carl Gustav Carus

Brief Summary:
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 or disease Intervention/treatment Phase
Chronic Myeloid Leukemia Procedure: Application of activated donor T cells Phase 1 Phase 2

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

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 20 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Specific Cellular Immunotherapy in Patients With Chronic Myeloid Leukemia After Allogeneic Stem Cell Transplantation
Study Start Date : March 2005
Actual Primary Completion Date : December 2011

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

Primary Outcome Measures :
  1. Feasibility of the infusion of in-vitro activated donor T cells [ Time Frame: 5 years ]
  2. kinetic of BCR-ABL load after transplantation [ Time Frame: 5 years ]

Secondary Outcome Measures :
  1. Rate of acute and chronic GvHD [ Time Frame: 3 years ]
  2. Rate of infectious complications [ Time Frame: 2 years ]

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Ages Eligible for Study:   18 Years to 60 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00460629

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

Publications of Results:
Publications automatically indexed to this study by Identifier (NCT Number):
Responsible Party: University Hospital Carl Gustav Carus Identifier: NCT00460629     History of Changes
Other Study ID Numbers: EK126092000
First Posted: April 16, 2007    Key Record Dates
Last Update Posted: June 20, 2013
Last Verified: June 2013

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

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