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. Identifier: NCT00303290
Recruitment Status : Completed
First Posted : March 16, 2006
Last Update Posted : November 26, 2015
Information provided by (Responsible Party):
M.D. Anderson Cancer Center

March 15, 2006
March 16, 2006
November 26, 2015
January 2000
November 2014   (Final data collection date for primary outcome measure)
Complete Cytogenetic Response Rate after One Year on Therapy [ Time Frame: 1 year ]
Cytogenetic responses evaluated by routine cytogenetics.
To maintain the proportion of patients achieving a major cytogenetic response in patients with Ph-positive early chronic phase CML using PEG-Intron subcutaneously weekly and Ara-C subcutaneously daily.
Complete list of historical versions of study NCT00303290 on Archive Site
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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)
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.

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a bone marrow biopsy, an area of the hip is numbed with anesthetic, and a small amount of bone marrow and bone is withdrawn through a large needle.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.

Phase 1
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Chronic Myeloid Leukemia
  • 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
    Other Names:
    • Cytosar
    • Cytarabine
    • DepoCyt
    • Cytosine arabinosine hydrochloride
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)
  • Drug: Ara-C (cytosine arabinoside)
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*   Includes publications given by the data provider as well as publications identified by Identifier (NCT Number) in Medline.
Same as current
November 2014
November 2014   (Final data collection date for primary outcome measure)

Inclusion Criteria:

  1. Patients age 12 years or older with a diagnosis of Ph-positive or bcr-positive CML in early chronic phase CML (diagnosis < 12 months).
  2. Serum bilirubin less than 2mg%, serum creatinine less than 2mg%, and a performance status of 2 or less on Zubrod scale.
  3. Patients under age 55 years should have HLA A,B,C, and DR typing performed on themselves and their siblings. Patients under age 20 years and patients with late chronic phase, accelerated phase or blastic phase will be offered allogeneic bone marrow transplantation from a matched sibling as the first priority.

Exclusion Criteria:

  1. Severe heart disease (Class III, IV) Psychiatric disability (psychosis) Pregnant or lactating females
  2. Women of pregnancy potential must practice birth control methods because of the potential risk of fetal teratogenecity with these agents.
  3. Patients must sign an informed consent indicating they are aware of the investigational nature of this study, in keeping with the policies of the hospital.
  4. Definition of CML Phases: a. Early chronic phase: time from diagnosis to therapy < 12 months Late chronic phase: time from diagnosis to therapy > 12 months b. Blastic phase: presence of 30% blasts or more in the peripheral blood or bone marrow. c. Accelerated phase CML: presence of any of the following features: - Peripheral or marrow blasts 15% or more - Peripheral or marrow basophils 20% or more - Thrombocytopenia < 100 x 109L unrelated to therapy - Documented extramedullary blastic disease outside liver or spleen
  5. Continuation of # 4 d. Clonal evolution defined as the presence of additional clones other than the Ph chromosome is part of accelerated phase CML. Ph chromosome variants or complex Ph chromosome translocations are not considered to indicate disease acceleration. We have recently found clonal evolution to have a variable prognostic impact and may be suppressed with IFN-A therapy (22,23). Hence these patients will be eligible if no other therapy (22,23). Hence these patients will be eligible if no other accelerated phase signs are present.
Sexes Eligible for Study: All
12 Years and older   (Child, Adult, Older Adult)
Contact information is only displayed when the study is recruiting subjects
United States
NCI-2010-00887 ( Registry Identifier: NCI CTRP )
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M.D. Anderson Cancer Center
M.D. Anderson Cancer Center
Principal Investigator: Jorge E Cortes, MD The University of Texas N.D. Anderson Cancer Center
M.D. Anderson Cancer Center
November 2015

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP