NCT00303290

PEG Interferon Alpha 2B and Low-Dose Ara-C in Early Chronic Phase CML

Therapy of Early Chronic Phase Chronic Myelogenous Leukemia (CML) With SCH54031 (PEG Interferon Alpha 2B/PEG Intron) and Low-Dose Cytosine Arabinoside (Ara-C)

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 76 (actual)
• Sponsor: M.D. Anderson Cancer Center · Academic / Other
• Sex: All
• Age: 12 Years
• Healthy volunteers: Not accepted

Summary

The goal of this clinical research study is to see if a new interferon which is given only once a week with ARA-C works as well as standard interferon and low dose ARA-C. The safety of this treatment will also be studied.

Detailed description

If you agree to take part in this study, during treatment, you will have blood tests every 1 to 4 weeks. After 10 years, blood tests are recommended 2 times per year. Bone marrow samples will be taken every 3 months during the first year and then every 3 to 6 months. If you are on this study for 10 years or longer, the bone marrow collections will only be performed if the doctor thinks it is needed. To collect a bone marrow biopsy, an area of the hip is numbed with anesthetic, and a small amount of bone marrow and bone is withdrawn through a large needle. During treatment, you will receive PEG-Intron once a week. You will also receive Ara-C injections under the skin. You will be taught to inject yourself, or a family member or friend can be taught how to give injections. Treatment will be given to you in the outpatient clinic at MD Anderson or in a clinic close to you. You will receive treatment as long as it is helping to control the disease. Treatment will go on for about 5 to 20 years. This is an investigational study. The FDA has approved PEG-Intron only for research studies. About 100 patients will take part in this study. All will be enrolled at MD Anderson.

Conditions

• Chronic Myeloid Leukemia

Interventions

Type	Name	Description
DRUG	Peg Interferon Alpha 2b (Peg Intron)	4.5 micrograms/kg once a week
DRUG	Ara-C (cytosine arabinoside)	10 mg under the skin daily

Timeline

• Start date: 2000-01-01
• Primary completion: 2014-11-01
• Completion: 2014-11-01
• First posted: 2006-03-16
• Last updated: 2015-11-26

Locations

1 site across 1 country: United States