Leukemia Clinical Trial
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
Verified date | October 2018 |
Source | Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Completed |
Enrollment | 36 |
Est. completion date | September 2017 |
Est. primary completion date | September 2017 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years to 120 Years |
Eligibility |
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 |
Country | Name | City | State |
---|---|---|---|
United States | Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins | Baltimore | Maryland |
Lead Sponsor | Collaborator |
---|---|
Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins | National Cancer Institute (NCI) |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Progression-free Survival | Number of patients alive and without disease progression or relapse | 1 year after treatment has been stopped | |
Primary | Complete Remission Rate | Percentage of patients who achieved molecular remission as defined by polymerase chain reaction negativity. | Up to 18 months | |
Secondary | Time to Complete Molecular Remission | Number of months from randomization to molecular remission as defined by polymerase chain reaction negativity. | Up to 27 months | |
Secondary | Disease-free Survival | Median number of days to progression of disease in participants who stopped all treatment as directed by the protocol. | Up to 8 years | |
Secondary | Early Discontinuation | Number of participants unable to complete protocol-specified treatment due to toxicity. | 1 year |
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