PEG Interferon Alpha 2B and Low-Dose Ara-C in Early Chronic Phase CML
NCT ID: NCT00303290
Last Updated: 2015-11-26
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE1
76 participants
INTERVENTIONAL
2000-01-31
2014-11-30
Brief Summary
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Detailed Description
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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
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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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.
Peg Interferon Alpha 2b (Peg Intron)
4.5 micrograms/kg once a week
Ara-C (cytosine arabinoside)
10 mg under the skin daily
Interventions
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Peg Interferon Alpha 2b (Peg Intron)
4.5 micrograms/kg once a week
Ara-C (cytosine arabinoside)
10 mg under the skin daily
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
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
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.
12 Years
ALL
No
Sponsors
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Schering-Plough
INDUSTRY
M.D. Anderson Cancer Center
OTHER
Responsible Party
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Principal Investigators
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Jorge E Cortes, MD
Role: PRINCIPAL_INVESTIGATOR
The University of Texas N.D. Anderson Cancer Center
Locations
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The University of Texas M.D. Anderson Cancer Center
Houston, Texas, United States
Countries
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Related Links
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University of Texas MD Anderson Cancer Center Website
Other Identifiers
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NCI-2010-00887
Identifier Type: REGISTRY
Identifier Source: secondary_id
DM99-127
Identifier Type: -
Identifier Source: org_study_id