Azacitidine and Etanercept in Treating Patients With Myelodysplastic Syndromes
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ClinicalTrials.gov Identifier: NCT00118287 |
Recruitment Status
:
Completed
First Posted
: July 11, 2005
Results First Posted
: May 24, 2017
Last Update Posted
: May 24, 2017
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Condition or disease | Intervention/treatment | Phase |
---|---|---|
de Novo Myelodysplastic Syndromes Previously Treated Myelodysplastic Syndromes Secondary Myelodysplastic Syndromes | Drug: azacitidine Biological: etanercept | Phase 1 Phase 2 |
PRIMARY OBJECTIVES:
I. Determine the frequency of hematologic responses in patients with MDS to 5-aza (azacitidine) plus etanercept.
II. Determine the efficacy of 5-aza combined with etanercept in patients with low or intermediate (int)-1 risk who fail to respond to anti-thymocyte globulin (ATG) plus etanercept and for the purpose of this trial are considered as having progressive or "more advanced" disease.
III. Correlate results of ex vivo/in vitro studies on phenotypic, cytogenetic and functional disease characteristics with in vivo treatment responses, to identify parameters that are associated with a high probability of response.
OUTLINE:
Patients receive etanercept subcutaneously (SC) twice weekly during weeks 1 and 2 and azacitidine SC or intravenously (IV) over 10-40 minutes on days 1-7. Treatment repeats every 28 days for at least 3 courses. Treatment continues in the absence of disease progression or unacceptable toxicity.
Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 32 participants |
Intervention Model: | Single Group Assignment |
Masking: | None (Open Label) |
Primary Purpose: | Treatment |
Official Title: | Therapy of Myelodysplastic Syndrome (MDS) With Azacitidine Given in Combination With Etanercept: A Phase I/II Study. |
Study Start Date : | April 2005 |
Actual Primary Completion Date : | October 2008 |

Arm | Intervention/treatment |
---|---|
Experimental: Treatment (chemotherapy, chemoprotection)
Patients receive etanercept SC twice weekly during weeks 1 and 2 and azacitidine SC or IV over 10-40 minutes on days 1-7. Treatment repeats every 28 days for at least 3 courses. Treatment continues in the absence of disease progression or unacceptable toxicity.
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Drug: azacitidine
Given SC or IV
Other Names:
Biological: etanercept
Given SC
Other Names:
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- Frequency of Hematologic Responses, as Defined by International Working Group (IWG) Criteria [ Time Frame: Up to 2 years ]Count of participants with a hematologic improvement (erythroid, platelet, or neutrophil response), assessed at 3 months.

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Ages Eligible for Study: | 18 Years and older (Adult, Senior) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
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

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00118287
United States, Washington | |
Fred Hutchinson Cancer Research Center/University of Washington Cancer Consortium | |
Seattle, Washington, United States, 98109 |
Principal Investigator: | Bart Scott | Fred Hutchinson Cancer Research Center/University of Washington Cancer Consortium |
Responsible Party: | Bart Scott, Principal Investigator, Fred Hutchinson Cancer Research Center |
ClinicalTrials.gov Identifier: | NCT00118287 History of Changes |
Other Study ID Numbers: |
1926.00 NCI-2011-01818 ( Registry Identifier: CTRP (Clinical Trial Reporting Program) ) |
First Posted: | July 11, 2005 Key Record Dates |
Results First Posted: | May 24, 2017 |
Last Update Posted: | May 24, 2017 |
Last Verified: | April 2017 |
Additional relevant MeSH terms:
Syndrome Myelodysplastic Syndromes Preleukemia Disease Pathologic Processes Bone Marrow Diseases Hematologic Diseases Precancerous Conditions Neoplasms Azacitidine Etanercept Antimetabolites, Antineoplastic Antimetabolites Molecular Mechanisms of Pharmacological Action |
Antineoplastic Agents Enzyme Inhibitors Anti-Inflammatory Agents, Non-Steroidal Analgesics, Non-Narcotic Analgesics Sensory System Agents Peripheral Nervous System Agents Physiological Effects of Drugs Anti-Inflammatory Agents Antirheumatic Agents Gastrointestinal Agents Immunosuppressive Agents Immunologic Factors |