Status:
COMPLETED
Safety Assessment of a Multipeptide-gene Vaccine in CML
Lead Sponsor:
Tehran University of Medical Sciences
Conditions:
Leukemia, Myeloid, Chronic
Eligibility:
All Genders
18-65 years
Phase:
PHASE1
Brief Summary
The primary purpose of this study is to evaluate the safety of a peptide-gene vaccine against CML in patients under Imatinib treatment. We will also perform some laboratory tests suggesting biologica...
Detailed Description
* Patients will continue to take their current dose of Imatinib. * Patients will undergo HLA-typing to define the HLA A, B, and DR. * One constant dose of ten bcr-abl peptides (100μg each) will be adm...
Eligibility Criteria
Inclusion
- Patients with Philadelphia chromosome positive CML who are:
- of subtype b3a2
- In first complete hematologic response;
- have received imatinib for \> 12 months of which the last 3 months were at a stable dose of at least 400 mg/day;
- have PCR detectable BCR-ABL transcript by qRT-PCR, and
- with persistent disease, as defined by \<1 log reduction in peripheral blood or bone marrow BCR-ABL transcripts levels compared with a standardized baseline.
- Greater than or equal to 18 years in age
- No known infection with human immunodeficiency virus
- Physician and patient willingness to maintain the baseline dose of imatinib throughout the study period
- Written informed consent obtained from the patient
Exclusion
- Female patients who are pregnant or breast feeding or adults of childbearing age who are not using adequate birth control.
- Current use of systemic immunosuppressive medications
- ALT or AST \>3X Upper limit Normal
- Prior allogeneic stem cell transplantation
- Other experimental therapy within the past two months
- Prior participation in vaccine studies within the past six months
- Oxygen saturation of less than 95% at room air
- History of recent acute myocardial infarction, unstable angina, or pulmonary decompensation requiring hospitalization within the past 3 months.
- Concurrent and or uncontrolled psychiatric or medical condition which may interfere with the study completion.
Key Trial Info
Start Date :
February 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
November 1 2011
Estimated Enrollment :
12 Patients enrolled
Trial Details
Trial ID
NCT00455221
Start Date
February 1 2008
End Date
November 1 2011
Last Update
June 4 2012
Active Locations (1)
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1
Hematology-Oncology & SCT Research Center
Tehran, Tehran Province, Iran, 14114