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Main
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Note: This record shows only 22 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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19 February 2015 |
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Main ID: |
NCT00483067 |
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Date of registration:
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05/06/2007 |
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Prospective Registration:
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No |
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Primary sponsor: |
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Public title:
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2-Chlorodeoxyadenosine and Cytarabine in Patients With Idiopathic Hypereosinophilic Syndrome (HES)
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Scientific title:
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Phase II Study: 2-Chlorodeoxyadenosine (2-CdA) and Cytarabine (Ara-C) in Idiopathic Hypereosinophilic Syndrome (HES) |
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Date of first enrolment:
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March 1998 |
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Target sample size:
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13 |
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Recruitment status: |
Completed |
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URL:
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http://clinicaltrials.gov/show/NCT00483067 |
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Study type:
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Interventional |
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Study design:
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Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
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Phase:
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Phase 2
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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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Michael Andreeff, MD, PhD |
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Address:
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Telephone:
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Email:
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Affiliation:
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M.D. Anderson Cancer Center |
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Key inclusion & exclusion criteria
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Inclusion Criteria:
1. Patient must have diagnosis of idiopathic HES, defined as (1) no recent history of
allergic reaction or parasitic infection; (2) sustained (> 6 months)
hypereosinophilia (1,500/mm^3); and (3) signs or symptoms of organ involvement.
2. Age less than 76 years old.
3. Patient is not pregnant.
4. Zubrod performance status < 3.
5. Life expectancy is not severely limited by concomitant illness.
6. Serum creatinine < 2 mg/dL.
7. Serum bilirubin < 2 times upper limit of normal (2 mg/dL).
8. Alanine aminotransferase (SGPT) < 2 times upper limit of normal (112 IU/L).
9. Participant has completed the informed consent process, understands the
investigational nature of the study, agrees to participate, and has signed the
informed consent.
Exclusion Criteria:
1. Evidence of chronic active hepatitis or cirrhosis, and > 1 month from prior episode
of hepatitis.
2. Presence of an active infection.
3. HIV positive.
4. Has eosinophilic leukemia (defined by presence of clonal cytogenetic abnormalities).
5. Recent history of parasite infection.
6. Recent history of allergic reaction.
Age minimum:
N/A
Age maximum:
76 Years
Gender:
Both
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Health Condition(s) or Problem(s) studied
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Leukemia
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Intervention(s)
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Drug: Ara-C
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Drug: G-CSF (Granulocyte colony-stimulating factor)
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Drug: 2-CdA
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Primary Outcome(s)
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Patient Outcomes at 6 Weeks
[Time Frame: Baseline to 6 weeks timepoint (day 42)]
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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Results
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Results available:
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Date Posted:
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Date Completed:
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URL:
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