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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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16 December 2017 |
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Main ID: |
NCT00118287 |
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Date of registration:
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08/07/2005 |
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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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Azacitidine and Etanercept in Treating Patients With Myelodysplastic Syndromes
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Scientific title:
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Therapy of Myelodysplastic Syndrome (MDS) With Azacitidine Given in Combination With Etanercept: A Phase I/II Study. |
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Date of first enrolment:
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April 2005 |
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Target sample size:
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32 |
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Recruitment status: |
Completed |
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URL:
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https://clinicaltrials.gov/show/NCT00118287 |
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Study type:
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Interventional |
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Study design:
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Intervention model: Single Group Assignment. Primary purpose: Treatment. Masking: None (Open Label).
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Phase:
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Phase 1/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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Bart Scott |
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Address:
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Telephone:
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Email:
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Affiliation:
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Fred Hutchinson Cancer Research Center/University of Washington Cancer Consortium |
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Key inclusion & exclusion criteria
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Inclusion Criteria:
- Int-2 or high risk MDS patients
- Patients with low-risk or int-1 risk MDS by International Prognostic Scoring System
(IPSS) criteria with:
- Single or multilineage cytopenia (absolute neutrophil count [ANC] < 1500/µL,
hemoglobin [Hgb],10g/dL, or platelet count < 100,000/µL); or
- Transfusion requirement of at least 2 units of packed red blood cells over an 8
week period
- Serum creatinine =< 1.5x ULN (upper limit of normal)
- Aspartate aminotransferase (AST)/alanine aminotransferase (ALT) =< 2x ULN
- Performance status =< 2 (Eastern Cooperative Oncology Group [ECOG] scale, 0-5)
Exclusion Criteria:
- Patients who have previously received hematopoietic stem cell transplants,
specifically for MDS
- Patients with a diagnosis of acute myeloid leukemia (AML) by World Health Organization
(WHO) criteria (i.e >= 20% blasts) at time of enrollment
- Women of child bearing potential who are currently pregnant, lactating or who are not
willing to use contraception during the entire duration of the study
- Men who are unwilling to use contraception while receiving 5-aza
- Patients with severe disease other than MDS which is expected to prevent compliance
with the present protocol
- Patients with severe infections (pneumonia, septicemia, etc) within the 2 weeks prior
to the anticipated start of protocol treatment
- Patients who are currently receiving or within the preceding 2 weeks have received
cytotoxic therapy, hemopoietic growth factors, immunomodulatory therapy, or other
experimental therapy for the treatment of MDS
- Current evidence of uncontrolled cardiac arrhythmia or congestive heart failure
- Platelet count =< 10,000/mcl
- Absolute neutrophil count =< 250/mcl
- Prior treatment with 5-aza
- Known or suspected hypersensitivity to azacitidine or mannitol
Age minimum:
18 Years
Age maximum:
N/A
Gender:
All
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Health Condition(s) or Problem(s) studied
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Secondary Myelodysplastic Syndromes
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de Novo Myelodysplastic Syndromes
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Previously Treated Myelodysplastic Syndromes
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Intervention(s)
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Drug: azacitidine
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Biological: etanercept
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Primary Outcome(s)
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Frequency of Hematologic Responses, as Defined by International Working Group (IWG) Criteria
[Time Frame: Up to 2 years]
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Secondary ID(s)
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NCI-2011-01818
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1926.00
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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