To investigate whether patients with chronic-phase chronic myeloid leukemia (CP-CML) who have achieved a complete cytogenetic response (CCyR) on imatinib (IM) or nilotinib (N) can then be treated with a combination of the tyrosine kinase inhibitor (TKI) and interferon-α2b (PEG-IFN-a2b, \[IFN\]) for 2 years, subsequently have their therapy discontinued, and then maintain a durable molecular response off all therapy. Relapse-free survival (RFS) rate 1 year after discontinuation of the TKI and IFN will be the measurement of this objective.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
12
Patients will receive pegylated interferon α-2b (Pegintron®) (PEG-IFN-α2b) 150 µg subcutaneously, once a week. Patients and/or caregivers identified by the patient will be taught how to perform subcutaneous injections of the PEG-IFN-α2b by trained nurses in the chemotherapy infusion center at the University of Michigan Comprehensive Cancer Center. Those patients who do not feel comfortable receiving the injections outside of the cancer center, or are deemed unreliable in administering injections per the training nurse, will return to the cancer center infusion room on a weekly basis to receive subsequent injections.
Universtiy of Michigan
Ann Arbor, Michigan, United States
Relapse-free Survival (RFS) Rate 1 Year After Discontinuation of the TKI and IFN
To investigate whether patients with chronic-phase chronic myeloid leukemia (CP-CML) who have achieved a complete cytogenetic response (CCyR) on imatinib (IM) or nilotinib (N) can then be treated with a combination of the tyrosine kinase inhibitor (TKI) and interferon-α2b (PEG-IFN-a2b, \[IFN\]) for 2 years, subsequently have their therapy discontinued, and then maintain a durable molecular response off all therapy. Relapse-free survival (RFS) rate 1 year after discontinuation of the TKI and IFN will be the measurement of this objective.
Time frame: 3 years (2 years of treatment with TKI and IFN + 1 year of follow-up)
Quantitative Reverse Transcriptase-polymerase Chain Reaction (qRT-PCR) for the Bcr-Abl Transcript.
To determine whether the addition of PEG-IFN-a2b to a TKI (imatinib or nilotinib) improves upon the quality of the molecular remission seen with TKI alone, as measured by quantitative reverse transcriptase-polymerase chain reaction (qRT-PCR) for the Bcr-Abl transcript.
Time frame: 3 years (2 years of treatment with TKI and IFN + 1 year of follow-up)
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