Back to resultsProphylactic Transfer of Leukemia-reactive T Cells After Allogeneic Transplantation
Primary Purpose
Chronic Myeloid Leukemia
Status
Completed
Phase
Phase 1
Locations
Germany
Study Type
Interventional
Intervention
Application of activated donor T cells
Sponsored by
About this trial
This is an interventional treatment trial for Chronic Myeloid Leukemia focused on measuring Adoptive immunotherapy, BCR-ABL reactive T cells, Allogeneic Transplantation
Eligibility 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
Sites / Locations
- Medizinische Klinik und Poliklinik I
Outcomes
Primary Outcome Measures
Feasibility of the infusion of in-vitro activated donor T cells
kinetic of BCR-ABL load after transplantation
Secondary Outcome Measures
Rate of acute and chronic GvHD
Rate of infectious complications
Full Information
NCT ID
NCT00460629
First Posted
April 12, 2007
Last Updated
June 19, 2013
Sponsor
University Hospital Carl Gustav Carus
1. Study Identification
Unique Protocol Identification Number
NCT00460629
Brief Title
Prophylactic Transfer of Leukemia-reactive T Cells After Allogeneic Transplantation
Official Title
Specific Cellular Immunotherapy in Patients With Chronic Myeloid Leukemia After Allogeneic Stem Cell Transplantation
Study Type
Interventional
2. Study Status
Record Verification Date
June 2013
Overall Recruitment Status
Completed
Study Start Date
March 2005 (undefined)
Primary Completion Date
December 2011 (Actual)
Study Completion Date
undefined (undefined)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University Hospital Carl Gustav Carus
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
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
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Chronic Myeloid Leukemia
Keywords
Adoptive immunotherapy, BCR-ABL reactive T cells, Allogeneic Transplantation
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 1, Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
20 (Anticipated)
8. Arms, Groups, and Interventions
Intervention Type
Procedure
Intervention Name(s)
Application of activated donor T cells
Intervention Description
Ex-vivo generated donor T cells stimulated by antigen presenting cells loaded with peptides derived from leukemia-associated antigens
Primary Outcome Measure Information:
Title
Feasibility of the infusion of in-vitro activated donor T cells
Time Frame
5 years
Title
kinetic of BCR-ABL load after transplantation
Time Frame
5 years
Secondary Outcome Measure Information:
Title
Rate of acute and chronic GvHD
Time Frame
3 years
Title
Rate of infectious complications
Time Frame
2 years
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Martin Bornhäuser, MD
Organizational Affiliation
Medical Clinic, University Hospital Dresden
Official's Role
Principal Investigator
Facility Information:
Facility Name
Medizinische Klinik und Poliklinik I
City
Dresden
ZIP/Postal Code
01307
Country
Germany
12. IPD Sharing Statement
Citations:
PubMed Identifier
16990776
Citation
Bornhauser M, Thiede C, Babatz J, Schetelig J, Illmer T, Kiani A, Platzbecker U, Herr W, Rieber EP, Ehninger G, Schmitz M. Infusion of bcr/abl peptide-reactive donor T cells to achieve molecular remission of chronic myeloid leukemia after CD34+ selected allogeneic hematopoietic cell transplantation. Leukemia. 2006 Nov;20(11):2055-7. doi: 10.1038/sj.leu.2404383. Epub 2006 Aug 31. No abstract available.
Results Reference
result
PubMed Identifier
21540460
Citation
Bornhauser M, Thiede C, Platzbecker U, Kiani A, Oelschlaegel U, Babatz J, Lehmann D, Holig K, Radke J, Tuve S, Wermke M, Wehner R, Jahnisch H, Bachmann MP, Rieber EP, Schetelig J, Ehninger G, Schmitz M. Prophylactic transfer of BCR-ABL-, PR1-, and WT1-reactive donor T cells after T cell-depleted allogeneic hematopoietic cell transplantation in patients with chronic myeloid leukemia. Blood. 2011 Jun 30;117(26):7174-84. doi: 10.1182/blood-2010-09-308569. Epub 2011 May 3.
Results Reference
derived
Learn more about this trial
Prophylactic Transfer of Leukemia-reactive T Cells After Allogeneic Transplantation
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