Imatinib or Nilotinib With Pegylated Interferon-α2b in Chronic Myeloid Leukemia
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|ClinicalTrials.gov Identifier: NCT00573378|
Recruitment Status : Withdrawn
First Posted : December 14, 2007
Last Update Posted : June 24, 2016
|Condition or disease||Intervention/treatment||Phase|
|Chronic Myeloid Leukemia||Drug: PEG-IFN-a2b||Phase 2|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||0 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||A Combination of Imatinib or Nilotinib Together With Pegylated Interferon-α2b in Chronic-Phase Chronic Myeloid Leukemia: A Phase II Pilot Study Targeting Both the Primitive and Differentiated CML Progenitor Populations|
|Study Start Date :||October 2007|
|Actual Primary Completion Date :||November 2015|
|Estimated Study Completion Date :||October 2016|
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.
Other Name: Pegintron®
- Relapse-free survival (RFS) rate 1 year after discontinuation of the TKI and IFN [ Time Frame: 2 years ]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.
- Quantitative reverse transcriptase-polymerase chain reaction (qRT-PCR) for the Bcr-Abl transcript. [ Time Frame: 2 years ]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.
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): NCT00573378
|United States, Michigan|
|Universtiy of Michigan|
|Ann Arbor, Michigan, United States, 48109|
|Principal Investigator:||Dale L. Bixby, M.D.||University of Michigan|