Clinical trial · Interventional
Vaccine Therapy in Treating Patients With Chronic Phase Chronic Myelogenous Leukemia
A Multi-Center Pilot Phase II Trial of a Synthetic Tumor-Specific Breakpoint Peptide Vaccine in Patients With Chronic Myeloid Leukemia (CML) and Minimal Residual Disease
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Why stopped (as posted): Withdrawn because there were no dramatic changes in the main endpoint, as well as low enrollment numbers. The data are not interpretable in terms of efficacy.
Summary
Brief summary (as posted)
RATIONALE: Vaccines made from a peptide may help the body build an effective immune response to kill cancer cells. PURPOSE: This phase II trial is studying how well vaccine therapy works 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 |
|---|---|---|---|
| bcr-abl peptide vaccine | Biological | — | UNRESOLVED |
| reverse transcriptase-polymerase chain reaction | Genetic | — | UNRESOLVED |
Design
Arms and outcomes
Arms (0)
[]Primary outcomes (5)
- measure
- Number of Participants With One-log Decrease in Circulation Breakpoint Cluster Region-Abelson Murine Leukemia(BCR-ABL) Transcripts That Persists for at Least Three Months During the 1-year Treatment Period.
- timeFrame
- Every 3 months for the duration of the 1-year treatment period. .
- description
- One-log decrease in circulating BCR-ABL transcripts (RT-PCR) that persists for at least three months during the 1-year treatment period.
- measure
- Percentage of Patients Who Become RT-PCR-negative for BCR-ABL Transcripts
- timeFrame
- 12-24 Months
- measure
- Comparison of Response in Patients With B3A2 Junctions vs B2A2 Junctions
- timeFrame
- 12-24 Months
- measure
- Immunologic Response Over 1 Year
- timeFrame
- 12 months
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
DISEASE CHARACTERISTICS: * Diagnosis of Philadelphia chromosome-positive or BCR-ABL-positive chronic phase chronic myelogenous leukemia (CML) * In complete cytogenetic remission confirmed by 2 bone marrows ≥ 1 month apart * Minimal residual disease * Detectable BCR-ABL transcript levels obtained \< 6 months apart AND ≤ 0.5-log lower than the lowest value obtained within the past 6 months PATIENT CHARACTERISTICS: * Karnofsky performance status 80-100% * Bilirubin \< 2 times upper limit of normal (ULN) * Creatinine \< 1.5 times ULN * ALT and AST \< 2.5 times ULN PRIOR CONCURRENT THERAPY: * Recovered from prior therapy * No major surgery within the past 4 weeks * No prior chemotherapy * No prior immunosuppressive therapy * No prior corticosteroids * No prior stem cell transplantation * No radiotherapy within the past 4 weeks * No other concurrent investigational agents
References
Publications (0)
Data not yet available