Vaccine Therapy in Treating Patients With Philadelphia Chromosome-Positive Chronic Myelogenous Le… (NCT00466726) | Clinical Trial Compass
CompletedPhase 2
Vaccine Therapy in Treating Patients With Philadelphia Chromosome-Positive Chronic Myelogenous Leukemia
Italy57 participantsStarted 2007-03
Plain-language 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.
Who can participate
Age range
18 Years – 120 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
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
Trial details
NCT IDNCT00466726
SponsorGruppo Italiano Malattie EMatologiche dell'Adulto