Safety Assessment of a Multipeptide-Gene Vaccine in CM

Phase 1

Conditions: Chronic Myeloid Leukemia (CML).

Registration Number: IRCT138705071030N1

Lead Sponsor: Tehran University of Medical Sciences

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Complete

Sex: All

Target Recruitment: 12

Inclusion Criteria

Inclusion Criteria:

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 Criteria

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.

Study & Design

Study Type: interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
To assess safety of bcr-abl peptide vaccination in Ph+ or MRD CML patients. Timepoint: At enroll in study and 3 months after intervention. Method of measurement: log decrease in qRT-PCR BCR-ABL for at least 3 months.

Secondary Outcome Measures

Name	Time	Method
Molecular response. Timepoint: At enroll in study and 3 months after intervention. Method of measurement: log decrease in qRT-PCR BCR-ABL for at least 3 months.