Pegasys in Patients With Chronic Myeloid Leukemia (CML)
Condition: Leukemia
MeSH terms: Leukemia; Leukemia, Myeloid; Leukemia, Myelogenous, Chronic, BCR-ABL Positive
Intervention: PEG-IFNá-2a
Intervention description: 45 mcg given subcutaneously as a single weekly dose for 24 months.
Intervention MeSH terms: Peginterferon alfa-2a
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 2.0
Sex: All
Minimum age: 16 Years
Healthy volunteers: No
Keywords: Leukemia; Chronic Myeloid Leukemia; CML; Tyrosine Kinase Inhibitors; TKI; Complete cytogenetic remission; CCyR; Minimal residual disease; MRD; PEG-IFNa-2a; Pegasys; Peginterferon Alpha-2a; Philadelphia chromosome (Ph)-positive; BCR-ABL1-positive

Summary:

      The goal of this clinical research study is to learn if adding pegylated interferon-alfa 2a
      (Pegasys) to the TKI that you are already receiving can help to control CML. The safety of
      this treatment combination will also be studied.

      Pegasys is a form of the drug interferon. It is designed to help the body's immune system to
      fight infections. It may also affect the body's response to cancer.

      A TKI (imatinib mesylate, nilotinib, or dasatinib) is designed to bind to and shut off a
      protein in tumor cells called Bcr-Abl. Shutting Bcr-Abl off may prevent CML cells from
      growing, and may cause them to die.

      You are already receiving a TKI. This consent form will describe the administration of
      Pegasys, any tests and procedures that need to be performed while you are receiving Pegasys,
      and any risks/benefits there may be from receiving Pegasys.
    

Eligibility criteria:

        Inclusion Criteria:

          1. Patients 16 years or older with Philadelphia chromosome (Ph)-positive or
             BCR-ABL1-positive CML (as determined by cytogenetics, FISH, or PCR).

          2. Patients are receiving an FDA-approved TKI for the management of CML.

          3. Patients must have received TKI therapy for at least 24 months and not have increased
             their TKI dose in the last 6 months.

          4. Patients must be in complete cytogenetic remission.

          5. Patients must have detectable BCR-ABL1 transcript levels meeting at least one of the
             following criteria: 1. The patient has received therapy for at least 2 years and does
             not have a sustained major molecular response, or 2. The patient has received therapy
             for at least 5 years and does not have a sustained complete molecular response.

          6. Patients must not have had a known continuous interruption of TKI therapy of greater
             than 14 consecutive days or for a total of 6 weeks in the 6 months prior to
             enrollment.

          7. Patients must sign an informed consent indicating that they are aware of the
             investigational nature of this study.

          8. Eastern Cooperative Oncology Group (ECOG) performance status </= 2.

          9. Adequate organ function defined as: bilirubin < 2x upper limit of normal (ULN) (unless
             associated with Gilbert's syndrome), creatinine </= 1.5x ULN, and serum glutamate
             pyruvate transaminase (sGPT) or serum glutamate oxaloacetate transaminase (sGOT) </=
             2.5x ULN.

         10. Men and women of childbearing potential should practice effective methods of
             contraception. Women of childbearing potential must have a negative serum or urine
             pregnancy test within 1 week of enrollment.

        Exclusion Criteria:

          1. Patients receiving any non-FDA approved TKI.

          2. Patients who are pregnant or breast-feeding.

          3. Patients with clinically significant heart disease (NYHA Class III or IV).