Safety Assessment of a Peptide Vaccine Derived From Bcr-abl Along With Cytokine Genes in CML Patients Undergoing Imatinib Treatment
- 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 administered
subcutaneously in all patients triweekly for 8 doses.
- Four different doses of IL-12 and GM-CSF plasmids will be tested in this trial. The
plasmids will be administered subcutaneously near the vaccination site 24 hours before
- The first three patients will receive the lower dose of both IL-12 and GM-CSF plasmids.
If this is well tolerated, then the next three patients will receive the lower dose of
IL-12 plasmid and higher dose of GM-CSF plasmid. If this is well tolerated, then the
next three patients will receive the higher dose of IL-12 and lower dose of GM-CSF
plasmids. If this is well tolerated, then the next three patients will receive the
higher dose of both IL-12 and GM-CSF plasmids. Once assigned to a dose, the patient
will receive the same dose throughout their participation in this trial.
- Each vaccination may consist of one to several shots placed under the skin on the
forearm, thigh or trunk area, and the sites will rotate per vaccination.
- During the clinic visit for vaccinations, blood tests will be drawn. If, during the
course of therapy, side effects develop that the doctor feels pose a threat to the
patient, treatment will be stopped.
- Patients will also undergo DTH skin tests before and after vaccination to see if an
immune reaction is occurring at the injection site.
- Patients' lymphocytes will be tested before and after vaccination regarding IFN-γ and
IL-4 production to assess immune system activation.
- During the course of treatment we will measure the effect the vaccine is having on the
patients CML every three months by:
1. doing a bone marrow biopsy and aspirate analysis, and
2. measuring the amount of BCR-ABL that is detectable by RT-PCR in the patients'
peripheral blood and bone marrow aspirate.
Allocation: Non-Randomized, Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
To assess safety of bcr-abl peptide vaccination in Ph+ or MRD CML patients
At enroll in study and 3 months after intervention
Seyed Hamidollah Ghaffari, PhD
Tehran University of Medical Sciences
Iran: Ministry of Health