A Multi-Center Pilot Phase II Trial of a Synthetic Tumor-Specific Breakpoint Peptide Vaccine in Patients With Chronic Myeloid Leukemia (CML) and Minimal Residual Disease
- Determine the antileukemic effects of tumor-specific Breakpoint Cluster Region-Abelson
Murine Leukemia(BCR-ABL) junction specific peptide vaccine, as measured by a decrease
in circulating BCR-ABL transcripts by reverse-transcriptase polymerase chain reaction
(RT-PCR), that persist for at least 3 months, in patients with chronic phase chronic
- Determine the percentage of patients treated with this vaccine who become
RT-PCR-negative for BCR-ABL transcripts.
- Compare response in patients with B3A2 junctions vs B2A2 junctions when treated with
- Determine the immunologic response over 1 year in patients treated with this vaccine.
- Correlate response with specific HLA types in these patients.
- Determine the safety of this vaccine in these patients.
OUTLINE: This is a pilot, multicenter study.
Patients receive BCR-ABL junction-specific peptide vaccine subcutaneously in weeks 2, 4, 6,
8, and 11 and then once monthly for 10 months.
BCR-ABL transcript levels are assessed by quantitative reverse-transcriptase polymerase
chain reaction at baseline, weeks 2, 4, and 6, every 3 months during treatment, and then 2
weeks after completion of study treatment.
PROJECTED ACCRUAL: A total of 20 patients will be accrued for this study.
Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Number of Participants With One-log Decrease in Circulation Breakpoint Cluster Region-Abelson Murine Leukemia(BCR-ABL) Transcripts That Persists for at Least Three Months During the 1-year Treatment Period.
One-log decrease in circulating BCR-ABL transcripts (RT-PCR) that persists for at least three months during the 1-year treatment period.
Every 3 months for the duration of the 1-year treatment period. .
Michael Deininger, MD, PhD
OHSU Knight Cancer Institute
United States: Federal Government
|OHSU Knight Cancer Institute||Portland, Oregon 97239|