Interferon and GM-CSF Compared With Imatinib Mesylate and Vaccine Therapy in Patients With Chronic Phase CML on a TKI
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|ClinicalTrials.gov Identifier: NCT00363649|
Recruitment Status : Completed
First Posted : August 15, 2006
Results First Posted : November 13, 2018
Last Update Posted : November 13, 2018
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.
|Condition or disease||Intervention/treatment||Phase|
|Leukemia||Biological: GM-K562 cell vaccine Biological: Interferon alfa Biological: Sargramostim||Phase 2|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||36 participants|
|Intervention Model:||Crossover Assignment|
|Intervention Model Description:||Participants were randomly assigned to Arm A or Arm B and received up to twelve months of protocol therapy. If at any point a participant progressed, relapsed, or had unacceptable toxicity, they could cross over to the other arm. Participants could only cross over once.|
|Masking:||None (Open Label)|
|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|
|Actual Study Start Date :||September 2006|
|Actual Primary Completion Date :||September 2017|
|Actual Study Completion Date :||September 2017|
Experimental: Arm A
Patients will receive injections of interferon alfa and sargramostim 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: Interferon alfa
Given by injection
Given by injection
Other Name: GM-CSF
Experimental: Arm B
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 + sargramostim (Arm A).
Biological: GM-K562 cell vaccine
Given by injection
- Progression-free Survival [ Time Frame: 1 year after treatment has been stopped ]Number of patients alive and without disease progression or relapse
- Complete Remission Rate [ Time Frame: Up to 18 months ]Percentage of patients who achieved molecular remission as defined by polymerase chain reaction negativity.
- Time to Complete Molecular Remission [ Time Frame: Up to 27 months ]Number of months from randomization to molecular remission as defined by polymerase chain reaction negativity.
- Disease-free Survival [ Time Frame: Up to 8 years ]Median number of days to progression of disease in participants who stopped all treatment as directed by the protocol.
- Early Discontinuation [ Time Frame: 1 year ]Number of participants unable to complete protocol-specified treatment due to toxicity.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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 at Johns Hopkins|