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Azacitidine and Etanercept in Treating Patients With Myelodysplastic Syndromes

Information source: Fred Hutchinson Cancer Research Center
ClinicalTrials.gov processed this data on August 20, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: de Novo Myelodysplastic Syndromes; Previously Treated Myelodysplastic Syndromes; Secondary Myelodysplastic Syndromes

Intervention: azacitidine (Drug); etanercept (Biological)

Phase: Phase 1/Phase 2

Status: Completed

Sponsored by: Fred Hutchinson Cancer Research Center/University of Washington Cancer Consortium

Official(s) and/or principal investigator(s):
Bart Scott, Principal Investigator, Affiliation: Fred Hutchinson Cancer Research Center/University of Washington Cancer Consortium


This phase I/II trial studies how well giving azacitidine together with etanercept works in treating patients with myelodysplastic syndromes (MDS). Drugs used in chemotherapy, such as azacitidine, works in different ways to stop the growth of cancer cells, either by killing the cells or by stopping them from dividing. Chemoprotective drugs, such as etanercept, may protect normal cells from the side effects of chemotherapy

Clinical Details

Official title: Therapy of Myelodysplastic Syndrome (MDS) With Azacitidine Given in Combination With Etanercept: A Phase I/II Study.

Study design: Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Primary outcome: Frequency of hematologic responses, as defined by International Working Group (IWG) criteria

Detailed description: 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.


Minimum age: 18 Years. Maximum age: N/A. Gender(s): Both.


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

Locations and Contacts

Fred Hutchinson Cancer Research Center/University of Washington Cancer Consortium, Seattle, Washington 98109, United States
Additional Information

Starting date: April 2005
Last updated: February 17, 2012

Page last updated: August 20, 2015

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