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Main
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Note: This record shows only the 20 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ClinicalTrials.gov |
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Last refreshed on:
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17 October 2012 |
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Main ID: |
NCT00428077 |
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Date of registration:
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25/01/2007 |
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Primary sponsor: |
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Public title:
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Vaccine Therapy in Treating Patients With Chronic Phase Chronic Myelogenous Leukemia
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Scientific title:
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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 |
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Date of first enrolment:
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October 2005 |
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Target sample size:
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4 |
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Recruitment status: |
Terminated |
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URL:
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http://clinicaltrials.gov/show/NCT00428077 |
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Study type:
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Interventional |
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Study design:
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Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
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Countries of recruitment
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United States
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Contacts
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Name:
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Michael Deininger, MD, PhD |
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Address:
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Telephone:
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Email:
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Affiliation:
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OHSU Knight Cancer Institute |
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Key inclusion & exclusion criteria
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DISEASE CHARACTERISTICS:
- Diagnosis of Philadelphia chromosome-positive or BCR-ABL-positive chronic phase
chronic myelogenous leukemia (CML)
- In complete cytogenetic remission confirmed by 2 bone marrows = 1 month apart
- Minimal residual disease
- Detectable BCR-ABL transcript levels obtained < 6 months apart AND = 0.5-log lower
than the lowest value obtained within the past 6 months
PATIENT CHARACTERISTICS:
- Karnofsky performance status 80-100%
- Bilirubin < 2 times upper limit of normal (ULN)
- Creatinine < 1.5 times ULN
- ALT and AST < 2.5 times ULN
PRIOR CONCURRENT THERAPY:
- Recovered from prior therapy
- No major surgery within the past 4 weeks
- No prior chemotherapy
- No prior immunosuppressive therapy
- No prior corticosteroids
- No prior stem cell transplantation
- No radiotherapy within the past 4 weeks
- No other concurrent investigational agents
Age minimum:
18 Years
Age maximum:
N/A
Gender:
Both
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Health Condition(s) or Problem(s) studied
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Leukemia
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Intervention(s)
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Biological: bcr-abl peptide vaccine
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Genetic: reverse transcriptase-polymerase chain reaction
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Primary Outcome(s)
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Comparison of Response in Patients With B3A2 Junctions vs B2A2 Junctions
[Time Frame: 12-24 Months]
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Correlation of Response With Specific HLA Types
[Time Frame: 12-24 Months]
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Immunologic Response Over 1 Year
[Time Frame: 12 months]
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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.
[Time Frame: Every 3 months for the duration of the 1-year treatment period. .]
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Percentage of Patients Who Become RT-PCR-negative for BCR-ABL Transcripts
[Time Frame: 12-24 Months]
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Secondary Outcome(s)
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Safety of a Vaccine Containing Native and Synthetic Chronic Myeloid Leukemia (CML) Peptides Over 1 Year Treatment.
[Time Frame: Weeks 2, 4, 6, 9, and monthly thereafter up to 2 years.]
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Secondary ID(s)
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CDR0000526322
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OHSU-1358
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OHSU-HEM-05053-L
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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