Clinical trial · Interventional
Vaccine Therapy in Treating Patients With Philadelphia Chromosome-Positive Chronic Myelogenous Leukemia
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
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Leukemia | Leukemia | ONTOLOGY_EXACT | 0.90 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| bcr-abl p210-b3a2 breakpoint-derived multipeptide vaccine | Biological | — | UNRESOLVED |
| sargramostim | Biological | — | UNRESOLVED |
Design
Arms and outcomes
Arms (0)
[]Primary outcomes (1)
- measure
- Number of Patients Showing a Reduction by at Least 50% of Peripheral Blood BCR-ABL/ABL Ratio Compared to the Individual Prevaccine Level
- timeFrame
- At 6 and 9 months
- description
- Response rate evaluated after immunization and reinforcement boosts (evaluation after 6 months, ) and persisting at the 9th month (after 10th vaccination)
Secondary outcomes (2)
- measure
- Number of Patients With Undetectable Transcript at Any Time After Immunization
- timeFrame
- Up to 6 months
- measure
- Number of Patients With Peptide-specific Immune Response Induced by the Vaccinations
- timeFrame
- At 9 months
- description
- A significant in vitro b3a2-peptide-specific CD4+ T cell proliferation
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 120 Years
Show eligibility criteria text
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 productsReferences
Publications (1)
- RESULTBCR-ABL Derived Peptide Vaccine in Chronic Myeloid Leukemia Patients with Molecular Minimal Residual Disease During Imatinib: Interim Analysis of a Phase 2 Multicenter GIMEMA CML Working Party Trial.