Vaccine Therapy in Treating Patients With Philadelphia Chromosome-Positive Chronic Myelogenous Leukemia (CML0206)
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|ClinicalTrials.gov Identifier: NCT00466726|
Recruitment Status : Completed
First Posted : April 27, 2007
Results First Posted : August 28, 2018
Last Update Posted : August 28, 2018
RATIONALE: Vaccines made from peptides may help the body build an effective immune response to kill cancer cells. Colony-stimulating factors, such as GM-CSF, may increase the number of immune cells found in bone marrow or peripheral blood. Giving booster vaccinations may make a stronger immune response and prevent or delay the recurrence of cancer.
PURPOSE: This phase II trial is studying how well vaccine therapy works in treating patients with Philadelphia chromosome-positive chronic myelogenous leukemia.
|Condition or disease||Intervention/treatment||Phase|
|Leukemia||Biological: bcr-abl p210-b3a2 breakpoint-derived multipeptide vaccine Biological: sargramostim||Phase 2|
- Determine the activity of bcr-abl p210-b3a2 breakpoint-derived pentapeptide vaccine (CMLVAX100), in terms of peripheral blood bcr-abl/abl ratio reduction, in patients with Philadelphia chromosome-positive chronic myelogenous leukemia.
- Determine the reduction of molecular residual disease at 3 months in patients treated with this vaccine.
- Determine the reduction of molecular residual disease at 12 months in patients treated with maintenance boosts of this vaccine.
- Determine the rate of complete molecular response at any time after vaccination.
- Determine in vivo and in vitro peptide-specific immune response induced by the vaccine.
OUTLINE: This is a prospective, nonrandomized, open-label, multicenter study.
Patients receive sargramostim (GM-CSF) subcutaneously (SC) on days 1 and 2 and bcr-abl p210-b3a2 breakpoint-derived pentapeptide vaccine (CMLVAX100) SC on day 2. Treatment repeats every 2 weeks for 6 courses. Patients then receive CMLVAX100 SC once monthly for 3 months and then once every 3 months for 6 months (for a total of 1 year). Patients may receive additional CMLVAX100 SC every 6 months for at least 3 years. Treatment continues in the absence of disease progression or unacceptable toxicity.
PROJECTED ACCRUAL: A total of 69 patients will be accrued for this study.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||57 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Phase II Multicenter Study of P210-B3A2 Derived Peptide Vaccine in Chronic Myeloid Leukemia Patients in Complete Cytogenetic Response With Persistent Molecular Residual Disease During Imatinib Treatment|
|Study Start Date :||March 2007|
|Actual Primary Completion Date :||July 2014|
|Actual Study Completion Date :||July 2014|
- Number of Patients Showing a Reduction by at Least 50% of Peripheral Blood BCR-ABL/ABL Ratio Compared to the Individual Prevaccine Level [ Time Frame: At 6 and 9 months ]Response rate evaluated after immunization and reinforcement boosts (evaluation after 6 months, ) and persisting at the 9th month (after 10th vaccination)
- Number of Patients With Undetectable Transcript at Any Time After Immunization [ Time Frame: Up to 6 months ]
- Number of Patients With Peptide-specific Immune Response Induced by the Vaccinations [ Time Frame: At 9 months ]A significant in vitro b3a2-peptide-specific CD4+ T cell proliferation
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00466726
|Study Chair:||Monica Bocchia, MD||Nouvo Policlinico "LE SCOTTE'|