Phase 2
N=57
Vaccine Therapy in Treating Patients With Philadelphia Chromosome-Positive Chronic Myelogenous Leukemia
Leukemia
Bottom Line
View on ClinicalTrials.gov: NCT00466726 ↗Enrolled (actual)
57
Serious AEs
0.0%
Results posted
Aug 2018
Primary outcome: Primary: Number of Patients Showing a Reduction by at Least 50% of Peripheral Blood BCR-ABL/ABL Ratio Compared to the Individual Prevaccine Level — 22; 14 participants
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- bcr-abl p210-b3a2 breakpoint-derived multipeptide vaccine (Biological); sargramostim (Biological)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Gruppo Italiano Malattie EMatologiche dell'Adulto
- Primary completion
- Jul 2014
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Patients Showing a Reduction by at Least 50% of Peripheral Blood BCR-ABL/ABL Ratio Compared to the Individual Prevaccine Level |
22; 14 | — |
| SECONDARY Number of Patients With Undetectable Transcript at Any Time After Immunization |
14 | — |
| SECONDARY Number of Patients With Peptide-specific Immune Response Induced by the Vaccinations |
29 | — |
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.
Eligibility 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
Data sourced from ClinicalTrials.gov (NCT00466726). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.