Pegasys in Patients With Chronic Myeloid Leukemia (CML)

Stopped early · Phase 2

Conditions studied: Leukemia

In brief

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.

Key facts

Study ID

NCT01392170

Run by

M.D. Anderson Cancer Center

People needed

2

Starts

2011-10-01

Expected to finish

2014-03-01

Last updated by the study team

2015-05-04

Who can join

Age: 16 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Patients 16 years or older with Philadelphia chromosome (Ph)-positive or BCR-ABL1-positive CML (as determined by cytogenetics, FISH, or PCR).
• Patients are receiving an FDA-approved TKI for the management of CML.
• Patients must have received TKI therapy for at least 24 months and not have increased their TKI dose in the last 6 months.
• Patients must be in complete cytogenetic remission.
• 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.
• 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.
• Patients must sign an informed consent indicating that they are aware of the investigational nature of this study.
• Eastern Cooperative Oncology Group (ECOG) performance status </= 2.
• 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.
• 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.

You may not qualify if…

• Patients receiving any non-FDA approved TKI.
• Patients who are pregnant or breast-feeding.
• Patients with clinically significant heart disease (NYHA Class III or IV).

Where it is running

• University of Texas MD Anderson Cancer Center — Houston, Texas, United States

Full record on ClinicalTrials.gov

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