Ignite Creation Date:
2024-05-05 @ 5:30 PM
Last Modification Date:
2024-10-26 @ 9:32 AM
Study NCT ID:
NCT00466726
Status:
COMPLETED
Last Update Posted:
2018-08-28
First Post:
2007-04-25
Brief Title:
Vaccine Therapy in Treating Patients With Philadelphia Chromosome-Positive Chronic Myelogenous Leukemia
Sponsor:
Gruppo Italiano Malattie EMatologiche dellAdulto
Organization:
Gruppo Italiano Malattie EMatologiche dellAdulto
Study Overview
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
Status:
COMPLETED
Status Verified Date:
2018-08
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
CML0206
Brief Summary:
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
PURPOSE This phase II trial is studying how well vaccine therapy works in treating patients with Philadelphia chromosome-positive chronic myelogenous leukemia
Detailed Description:
OBJECTIVES
Primary
Determine the activity of bcr-abl p210-b3a2 breakpoint-derived pentapeptide vaccine CMLVAX100 in terms of peripheral blood bcr-ablabl ratio reduction in patients with Philadelphia chromosome-positive chronic myelogenous leukemia
Secondary
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
Primary
Determine the activity of bcr-abl p210-b3a2 breakpoint-derived pentapeptide vaccine CMLVAX100 in terms of peripheral blood bcr-ablabl ratio reduction in patients with Philadelphia chromosome-positive chronic myelogenous leukemia
Secondary
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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| 2006-006189-40 | EUDRACT_NUMBER | None | None |