Clinical trial · Interventional
Vaccine Therapy in Treating Patients With Chronic Myelogenous Leukemia
Phase II, Multicenter Vaccination of Patients With Chronic Myelogenous Leukemia With a Multivalent Tumor Specific Breakpoint Peptide Vaccine
NCT00004052CI-TRIAL-00011026completedPhase 2ClinicalTrials.gov clinicaltrialsProvenance
- 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 may make the body build an immune response to kill cancer cells. PURPOSE: Phase II trial to study the effectiveness of vaccine therapy in treating patients who have 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 peptide vaccine | Biological | — | UNRESOLVED |
| QS21 | Biological | — | UNRESOLVED |
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 16 Years
Show eligibility criteria text
DISEASE CHARACTERISTICS: * Histologically proven chronic myelogenous leukemia * Must have (9;22) translocation or bcr/abl transcript, and b3a2 breakpoint * No accelerated or blastic phase * Must be in hematologic remission with peripheral WBC less than 20,000/mm\^3 PATIENT CHARACTERISTICS: Age: * Over 16 Performance status: * Karnofsky 70-100% Life expectancy: * Not specified Hematopoietic: * See Disease Characteristics * Absolute granulocyte count greater than 1,200/mm\^3 * Platelet count greater than 70,000/mm\^3 * Hemoglobin greater than 9.0 g/dL * No active bleeding Hepatic: * Bilirubin less than 2.0 mg/dL * Lactate dehydrogenase less than 2 times normal Renal: * Creatinine less than 2.0 mg/dL Cardiovascular: * No New York Heart Association class III or IV heart disease Other: * No uncontrolled active infection requiring antibiotics * No other serious illness * No immunodeficiency other than from prior bone marrow transplantation * Not pregnant or nursing PRIOR CONCURRENT THERAPY: Biologic therapy: * At least 6 months since prior allogeneic or autologous bone marrow transplantation * Prior vaccination with pentavalent peptide at less than study dose level allowed * At least 4 weeks since prior immunotherapy other than interferon, donor lymphocyte infusion, or pentavalent vaccine * Concurrent interferon allowed Chemotherapy: * At least 2 weeks since prior low-dose subcutaneous cytarabine * At least 4 weeks since prior chemotherapy other than hydroxyurea * No concurrent chemotherapy except hydroxyurea Endocrine therapy: * No concurrent corticosteroids Radiotherapy: * At least 4 weeks since prior radiotherapy * No concurrent radiotherapy Surgery: * No concurrent surgery Other: * Concurrent imatinib mesylate allowed * No other concurrent systemic therapy
References
Publications (0)
Data not yet available
No reference posted for this study.