Interferon and GM-CSF Compared With Imatinib Mesylate and Vaccine Therapy in Patients With Chroni… (NCT00363649) | Clinical Trial Compass
CompletedPhase 2
Interferon and GM-CSF Compared With Imatinib Mesylate and Vaccine Therapy in Patients With Chronic Phase CML on a TKI
United States36 participantsStarted 2006-09
Plain-language summary
RATIONALE: Tyrosine kinase inhibitors may stop the growth of cancer cells by blocking some of the enzymes needed for cell growth. Interferon alfa may interfere with the growth of cancer cells. GM-CSF may help cells that are involved in the body's immune response work better. Vaccines made from a person's cancer cells may help the body build an effective immune response to kill cancer cells.
PURPOSE: This randomized phase II trial is studying tyrosine kinase inhibitors, interferon alfa, and GM-CSF to see how well they work compared to tyrosine kinase inhibitors and vaccine therapy in treating patients with chronic phase 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) in chronic phase based on cytogenetic detection of the Philadelphia chromosome and/or detection of the BCR-ABL rearrangement by any of the following molecular methods:
* Recombinant DNA analysis of the BCR-ABL fusion gene
* Fluorescence in situ hybridization (FISH)
* Polymerase chain reaction detection of the BCR-ABL hybrid mRNA
* Documentation of complete cytogenetic response by conventional cytogenetic or FISH analysis while on a stable dose of tyrosine kinase inhibitor
* No other phase of CML
PATIENT CHARACTERISTICS:
* ECG performance status 0-2
* Life expectancy \> 24 months
* Not pregnant
* Negative pregnancy test
* Fertile patients must use effective contraception
* Creatinine ≤ 2.0 mg/dL
* Bilirubin ≤ 2.0 times upper limit of normal (ULN)
* AST and ALT ≤ 2.5 times ULN
* No other malignancy within the past 5 years except in situ cervical carcinoma or adequately treated nonmelanoma skin cancer
* No other disease requiring long-term corticosteroids or immunosuppressants
PRIOR CONCURRENT THERAPY:
* At least 28 days since prior investigational agents
* No prior bone marrow transplant or other transplant
* No concurrent immunosuppressants (e.g., steroids, cyclosporine, azathioprine, mycophenolate mofetil, sirolimus, or tacrolimus)
* No concurrent hydroxyurea, busulfan, or cytoreductive agents (other than frontline TKI)
* No other concurrent anticancer agents or therapies
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
Progression-free Survival
Timeframe: 1 year after treatment has been stopped
2
Complete Remission Rate
Timeframe: Up to 18 months
Trial details
NCT IDNCT00363649
SponsorSidney Kimmel Comprehensive Cancer Center at Johns Hopkins