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
18 Years
N/A
Both
Leukemia
Trial Information
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
OBJECTIVES:
Primary
- 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.
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.
Inclusion Criteria
DISEASE CHARACTERISTICS:
- Diagnosis of chronic myelogenous leukemia (CML) meeting the following criteria:
- Philadelphia chromosome positive disease
- b3a2 breakpoint mutation
- Prior treatment with conventional imatinib mesylate for ≥ 18 months required
- Complete cytogenetic response documented on ≥ 2 different examinations
- Persistence of molecularly detectable residual disease (any level of
bcr-abl transcript)
- Patients continue to receive imatinib mesylate at the same dose (conventional
treatment) during study treatment
PATIENT CHARACTERISTICS:
- WHO performance status 0-1
- Bilirubin ≤ 2 times upper limit of normal (ULN)
- AST and ALT ≤ 2.5 times ULN
- Creatinine ≤ 1.5 times ULN
- Not pregnant or nursing
- Negative pregnancy test
- Fertile patients must use effective contraception
- No severe active infection or other serious medical illness that would preclude study
completion
- No known immunodeficiency
- No autoimmune disorders
PRIOR CONCURRENT THERAPY:
- No concurrent immunosuppression or systemic immunosuppressive medication
- No concurrent dose escalation of imatinib mesylate
- No other concurrent investigational products
Type of Study:
Interventional
Study Design:
Allocation: Non-Randomized, Masking: Open Label, Primary Purpose: Treatment
Outcome Measure:
Response rate at 6 and 9 months
Safety Issue:
No
Principal Investigator
Monica Bocchia, MD
Investigator Role:
Study Chair
Investigator Affiliation:
Nouvo Policlinico "LE SCOTTE'
Authority:
Unspecified
Study ID:
CDR0000540577
NCT ID:
NCT00466726
Start Date:
March 2007
Completion Date:
Related Keywords:
- Leukemia
- chronic myelogenous leukemia, BCR-ABL1 positive
- accelerated phase chronic myelogenous leukemia
- blastic phase chronic myelogenous leukemia
- chronic phase chronic myelogenous leukemia
- relapsing chronic myelogenous leukemia
- Leukemia
- Leukemia, Myeloid
- Leukemia, Myelogenous, Chronic, BCR-ABL Positive
- Philadelphia Chromosome
Name | Location |
|---|
