Safety Assessment of a Multipeptide-gene Vaccine in CML

Plain-language summary

This study assessed the safety of a multipeptide vaccine targeting the Bcr-abl fusion protein, given with a cytokine gene adjuvant, in patients with Philadelphia chromosome-positive chronic myeloid leukaemia. Participants had received imatinib for at least 12 months and were in first complete haematological response. It was carried out as a Phase 1 study and has been completed.

The summary above is a plain-language rendering of the official record. The original English title is shown for reference.

Trial details

Phase

Phase 1

Status

Completed

Sponsor

Tehran University of Medical Sciences

Intervention

Bcr-abl multipeptide vaccine, Cytokine gene adjuvant

Start date

2/1/2008

Estimated completion

11/1/2011

Countries

Iran

Related genes

Locations

• Tehran, Iran

Eligibility criteria

Criteria are reproduced from the ClinicalTrials.gov record in the original English. Only the trial team can determine eligibility.

Inclusion Criteria:

* Patients with Philadelphia chromosome positive CML who are:

  1. of subtype b3a2
  2. In first complete hematologic response;
  3. have received imatinib for \> 12 months of which the last 3 months were at a stable dose of at least 400 mg/day;
  4. have PCR detectable BCR-ABL transcript by qRT-PCR, and
  5. 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.