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Main
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Note: This record shows only the 20 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ClinicalTrials.gov |
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Last refreshed on:
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17 October 2012 |
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Main ID: |
NCT00303290 |
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Date of registration:
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15/03/2006 |
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Primary sponsor: |
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Public title:
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PEG Interferon Alpha 2B and Low-Dose Ara-C in Early Chronic Phase CML
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Scientific title:
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Therapy of Early Chronic Phase Chronic Myelogenous Leukemia (CML) With SCH54031 (PEG Interferon Alpha 2B/PEG Intron) and Low-Dose Cytosine Arabinoside (Ara-C) |
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Date of first enrolment:
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January 2000 |
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Target sample size:
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100 |
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Recruitment status: |
Active, not recruiting |
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URL:
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http://clinicaltrials.gov/show/NCT00303290 |
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Study type:
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Interventional |
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Study design:
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Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
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Countries of recruitment
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United States
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Contacts
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Name:
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Jorge E Cortes, MD |
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Address:
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Telephone:
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Email:
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Affiliation:
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The University of Texas N.D. Anderson Cancer Center |
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Key inclusion & exclusion criteria
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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.
Age minimum:
12 Years
Age maximum:
N/A
Gender:
Both
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Health Condition(s) or Problem(s) studied
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Chronic Myeloid Leukemia
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Intervention(s)
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Drug: Ara-C (cytosine arabinoside)
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Drug: Peg Interferon Alpha 2b (Peg Intron)
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Primary Outcome(s)
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Complete Cytogenetic Response Rate after One Year on Therapy
[Time Frame: 1 year]
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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