PEG Interferon Alpha 2B and Low-Dose Ara-C in Early Chronic Phase CML
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT00303290|
Recruitment Status : Completed
First Posted : March 16, 2006
Last Update Posted : November 26, 2015
|Condition or disease||Intervention/treatment||Phase|
|Chronic Myeloid Leukemia||Drug: Peg Interferon Alpha 2b (Peg Intron) Drug: Ara-C (cytosine arabinoside)||Phase 1|
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a bone marrow biopsy, an area of the hip is numbed with anesthetic, and a small amount of bone marrow and bone is withdrawn through a large needle.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.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||76 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|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)|
|Study Start Date :||January 2000|
|Actual Primary Completion Date :||November 2014|
|Actual Study Completion Date :||November 2014|
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 week
Drug: Ara-C (cytosine arabinoside)
10 mg under the skin daily
- Complete Cytogenetic Response Rate after One Year on Therapy [ Time Frame: 1 year ]Cytogenetic responses evaluated by routine cytogenetics.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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|