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Imatinib or Nilotinib With Pegylated Interferon-α2b in Chronic Myeloid Leukemia

NCT00573378 · Status: TERMINATED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 12

Last updated 2023-01-25

Study results available
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Summary

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.

Conditions

  • Chronic Myeloid Leukemia

Interventions

DRUG

PEG-IFN-a2b

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.

Sponsors & Collaborators

  • University of Michigan Rogel Cancer Center

    lead OTHER

Principal Investigators

  • Dale L. Bixby, M.D. · University of Michigan

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2007-09-30
Primary Completion
2010-10-31
Completion
2015-12-31
FDA Drug
Yes

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00573378 on ClinicalTrials.gov