PEG Interferon Alpha 2B and Low-Dose Ara-C in Early Chronic Phase CML
|Chronic Myeloid Leukemia||Drug: Peg Interferon Alpha 2b (Peg Intron) Drug: Ara-C (cytosine arabinoside)||Phase 1|
|Study Design:||Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||Therapy of Early Chronic Phase Chronic Myelogenous Leukemia (CML) With SCH54031 (PEG Interferon Alpha 2B/PEG Intron) and Low-Dose Cytosine Arabinoside (Ara-C)|
- Complete Cytogenetic Response Rate after One Year on Therapy [ Time Frame: 1 year ]Cytogenetic responses evaluated by routine cytogenetics.
|Study Start Date:||January 2000|
|Study Completion Date:||November 2014|
|Primary Completion Date:||November 2014 (Final data collection date for primary outcome measure)|
Experimental: PEG-Intron + ARA-C
Peg Interferon Alpha 2b (Peg Intron) 4.5 micrograms/kg once a week. ARA-C 10 mg under the skin daily.
Drug: Peg Interferon Alpha 2b (Peg Intron)
4.5 micrograms/kg once a weekDrug: Ara-C (cytosine arabinoside)
10 mg under the skin daily
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a bone marrow biopsy, an area of the hip is numbed with anesthetic, and a small amount of bone marrow and bone is withdrawn through a large needle.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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00303290
|United States, Texas|
|The University of Texas M.D. Anderson Cancer Center|
|Houston, Texas, United States, 77030-4009|
|Principal Investigator:||Jorge E Cortes, MD||The University of Texas N.D. Anderson Cancer Center|