Specific Cellular Immunotherapy in Patients With Chronic Myeloid Leukemia After Allogeneic Stem Cell Transplantation
18 Years
60 Years
Both
Chronic Myeloid Leukemia
Trial Information
Specific Cellular Immunotherapy in Patients With Chronic Myeloid Leukemia After Allogeneic Stem Cell Transplantation
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
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
Type of Study:
Interventional
Study Design:
Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Outcome Measure:
Feasibility of the infusion of in-vitro activated donor T cells
Outcome Time Frame:
5 years
Safety Issue:
Yes
Principal Investigator
Martin Bornhäuser, MD
Investigator Role:
Principal Investigator
Investigator Affiliation:
Medical Clinic, University Hospital Dresden
Authority:
Germany: Federal Institute for Drugs and Medical Devices
Study ID:
EK126092000
NCT ID:
NCT00460629
Start Date:
March 2005
Completion Date:
Related Keywords:
- Chronic Myeloid Leukemia
- Adoptive immunotherapy
- BCR-ABL reactive T cells
- Allogeneic Transplantation
- Leukemia
- Leukemia, Myeloid
- Leukemia, Myelogenous, Chronic, BCR-ABL Positive
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