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

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborator:
Schering-Plough
Information provided by (Responsible Party):
M.D. Anderson Cancer Center
ClinicalTrials.gov Identifier:
NCT00303290
First received: March 15, 2006
Last updated: June 6, 2013
Last verified: June 2013

March 15, 2006
June 6, 2013
January 2000
January 2015   (final data collection date for primary outcome measure)
Complete Cytogenetic Response Rate after One Year on Therapy [ Time Frame: 1 year ] [ Designated as safety issue: No ]
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 ClinicalTrials.gov 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a bone marrow biopsy, an area of the hip is numbed with anesthetic, and a small amount of bone marrow and bone is withdrawn through a large needle.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.

Interventional
Phase 1
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: 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.
Interventions:
  • 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 ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Active, not recruiting
100
Not Provided
January 2015   (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.
Both
12 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00303290
DM99-127
No
M.D. Anderson Cancer Center
M.D. Anderson Cancer Center
Schering-Plough
Principal Investigator: Jorge E Cortes, MD The University of Texas N.D. Anderson Cancer Center
M.D. Anderson Cancer Center
June 2013

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