Clinical trial · Interventional
Vaccine Therapy and Imatinib Mesylate in Treating Patients With Chronic Phase Chronic Myelogenous Leukemia
Vaccination for CML Patients With Persistent Disease on Imatinib Mesylate
- 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 gene-modified cancer cells may help the body build an effective immune response to kill cancer cells. Imatinib mesylate may stop the growth of cancer cells by blocking some of the enzymes needed for cell growth. Giving vaccine therapy together with imatinib mesylate may be an effective treatment for chronic myelogenous leukemia. PURPOSE: This phase I trial is studying the side effects and best dose of vaccine therapy when given together with imatinib mesylate in treating patients with chronic phase 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 |
|---|---|---|---|
| GM-K562 cell vaccine | Biological | — | UNRESOLVED |
| imatinib mesylate | Drug | Imatinib Mesylate | ALIAS |
Design
Arms and outcomes
Arms (0)
[]Primary outcomes (1)
- measure
- Safety and Toxicity
- timeFrame
- 3 years
- description
- To assess the safety and toxicity of GM-K462 vaccination in CP CML patients who have acheived a complete hematologic response to imatinib.
Secondary outcomes (2)
- measure
- Disease Response
- timeFrame
- 3 years
- description
- To assess disease response after GM-K562 vaccination by serial BCR-ABL Q-PCR measurements
- measure
- Tumor immunity
- timeFrame
- 3 years
- description
- To characterize the development of tumor immunity in response to vaccination with GM-K562 cells
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
DISEASE CHARACTERISTICS: * Diagnosis of chronic myelogenous leukemia * Chronic phase disease * Philadelphia chromosome positive disease * Disease in first complete hematologic response, defined by all of the following: * Complete normalization of peripheral blood counts with WBC \< 10,000/mm\^3 * Platelet count \< 450,000/mm\^3 * No immature cells (e.g., myelocytes, metamyelocytes, or blasts) in the peripheral blood * Persistent molecular evidence of disease * Detectable BCR-ABL transcript by quantitative polymerase chain reaction * Less than 2 log reduction in peripheral blood or bone marrow BCR-ABL transcripts levels compared to a standardized baseline * Must have received imatinib mesylate for \> 1 year of which the last 3 months were at stable dose ≥ 300 mg/day PATIENT CHARACTERISTICS: * Not pregnant or nursing * Fertile patients must use effective contraception * Negative pregnancy test * No known HIV * ALT or AST ≤ 3 times upper limit of normal * Oxygen saturation ≥ 93% at room air * No history of recent acute myocardial infarction * No history of unstable angina * No pulmonary decomposition requiring hospitalization within the past 3 months * No concurrent and/or uncontrolled psychiatric or medical condition that would preclude study compliance PRIOR CONCURRENT THERAPY: * See Disease Characteristics * No prior allogeneic stem cell transplantation * At least 2 months since other prior experimental therapy * At least 6 months since prior participation in another vaccine study * No concurrent systemic immunosuppressive medication
References
Publications (0)
Data not yet available