Pegasys in Patients With Chronic Myeloid Leukemia (CML)

• Status: Terminated
• Trial end date: 2014-03-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: M.D. Anderson Cancer Center
• Treatments: Interferon-alpha; Peginterferon alfa-2a

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

9. Adequate organ function defined as: bilirubin < 2x upper limit of normal (ULN) (unless associated with Gilbert's syndrome), creatininepyruvate 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).