Interferon and GM-CSF Compared With Imatinib Mesylate and Vaccine Therapy in Patients With Chronic Phase CML on a TKI
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.
|Leukemia||Biological: GM-K562 cell vaccine Biological: recombinant interferon alfa Biological: sargramostim||Phase 2|
|Study Design:||Allocation: Randomized
Primary Purpose: Treatment
|Official Title:||A Randomized Phase II Trial of Interferon + GM-CSF Versus K562/GM-CSF Vaccination in CML Patients Achieving a Complete Cytogenetic Response to Frontline Tyrosine Kinase Inhibitor Therapy|
- Progression-free survival at 1 year
- Rate of molecular complete remission
- Time to Philadelphia chromosome (Ph) negativity as measured by polymerase chain reaction
- Disease-free survival
- Percent molecular complete remission
- Time to progression
|Study Start Date:||September 2006|
|Estimated Study Completion Date:||July 2020|
|Estimated Primary Completion Date:||July 2020 (Final data collection date for primary outcome measure)|
Experimental: Arm I
Patients will receive injections of interferon alfa and GM-CSF once a day for 6 months. Some patients may receive treatment for up to 1 year. After 1 year, some patients may receive treatment as in arm II.
Biological: recombinant interferon alfa
Given by injectionBiological: sargramostim
Given by injection
Experimental: Arm II
Patients will receive an injection of GM-K562 cell vaccine every 3 weeks for at least 6 months. Some patients may receive treatment for up to 1 year. After 1 year, some patients may receive treatment as in arm I. NOTE: Study Arm B is not available to newly accrued and enrolled subjects based on the interim analysis directing all new subjects to the combination of Interferon + GM-CSF (Arm A).
Biological: GM-K562 cell vaccine
Given by injection
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Please refer to this study by its ClinicalTrials.gov identifier: NCT00363649
|United States, Maryland|
|Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins|
|Baltimore, Maryland, United States, 21231|
|Principal Investigator:||B. Douglas Smith, MD||Sidney Kimmel Comprehensive Cancer Center|