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Sponsors and Collaborators: |
M.D. Anderson Cancer Center BreakThrough Therapeutics |
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Information provided by: | M.D. Anderson Cancer Center |
ClinicalTrials.gov Identifier: | NCT00267085 |
The goal of this clinical research study is to learn if giving 1 of 2 vaccines (CML-VAX B2 or CML-VAX B3) together with imatinib mesylate can decrease or eliminate all evidence of disease in patients who have CML that is in remission after treatment with imatinib mesylate, but who still have small amounts of detectable disease.
Condition | Intervention | Phase |
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Chronic Myeloid Leukemia Minimal Residual Disease |
Biological: Synthetic Tumor-Specific Breakpoint Peptide Vaccine |
Phase II |
Study Type: | Interventional |
Study Design: | Treatment, Non-Randomized, Open Label, Historical Control, Single Group Assignment, Safety/Efficacy Study |
Official Title: | A Pilot Phase II Trial of a Synthetic Tumor-Specific Breakpoint Peptide Vaccine in Patients With Chronic Myeloid Leukemia (CML) and Minimal Residual Disease |
Enrollment: | 11 |
Study Start Date: | December 2005 |
Study Completion Date: | July 2008 |
Primary Completion Date: | September 2007 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
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1: Experimental
CML-VAX B2 or CML-VAX B3
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Biological: Synthetic Tumor-Specific Breakpoint Peptide Vaccine
CML-VAX B2 or CML-VAX B3
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Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
United States, Texas | |
U.T.M.D. Anderson Cancer Center | |
Houston, Texas, United States, 77030 |
Principal Investigator: | Jorge E. Cortes, M.D. | U.T.M.D. Anderson Cancer Center |
Responsible Party: | The University of Texas M. D. Anderson Cancer Center ( Jorge Cortes M.D./Professor ) |
Study ID Numbers: | 2005-0392 |
Study First Received: | December 19, 2005 |
Last Updated: | July 31, 2008 |
ClinicalTrials.gov Identifier: | NCT00267085 |
Health Authority: | United States: Food and Drug Administration |
Chronic Myeloid Leukemia Minimal Residual Disease Peptide Vaccine |
Neoplasm, Residual Leukemia Chronic myelogenous leukemia Hematologic Diseases |
Myeloproliferative Disorders Leukemia, Myelogenous, Chronic, BCR-ABL Positive Leukemia, Myeloid Bone Marrow Diseases |
Neoplastic Processes Neoplasms Pathologic Processes Neoplasms by Histologic Type |