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Anti-Thymocyte Globulin and Etanercept in Treating Patients With Myelodysplastic Syndromes

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ClinicalTrials.gov Identifier: NCT00217386
Recruitment Status : Completed
First Posted : September 22, 2005
Last Update Posted : September 15, 2010
Information provided by:

Study Description
Brief Summary:

RATIONALE: Biological therapies, such as anti-thymocyte globulin and etanercept, may stimulate the immune system in different ways and stop cancer cells from growing. Giving anti-thymocyte globulin together with etanercept may kill more cancer cells.

PURPOSE: This phase II trial is studying how well giving anti-thymocyte globulin together with etanercept works in treating patients with myelodysplastic syndromes.

Condition or disease Intervention/treatment Phase
Leukemia Myelodysplastic Syndromes Myelodysplastic/Myeloproliferative Diseases Biological: anti-thymocyte globulin Biological: etanercept Phase 2

Detailed Description:


  • Determine the response rate in patients with low- or intermediate-1-risk myelodysplastic syndromes treated with anti-thymocyte globulin and etanercept.
  • Correlate ex vivo and in vitro phenotypic, cytogenetic, and functional disease characteristics with in vivo response in patients treated with this regimen.
  • Determine parameters that are associated with a high probability of response or non-response in patients treated with this regimen.

OUTLINE: This is a multicenter study.

Patients receive anti-thymocyte globulin IV over 8 hours on days 1-4. Patients also receive etanercept subcutaneously on days 8, 11, 15, and 18. Treatment with etanercept repeats every 28 days for at least 2 courses. Patients exhibiting hematologic improvement after course 2 may receive up to 2 additional courses of etanercept in the absence of disease progression or unacceptable toxicity. Patients with unresponsive disease or disease progression after course 2 are removed from the study and offered other treatment.

After completion of study treatment, patients are followed periodically.

PROJECTED ACCRUAL: A total of 30 patients will be accrued for this study within 3 years.

Study Design

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 30 participants
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Therapy of Early Stage Myelodysplastic Syndrome (MDS) With ATG and Etanercept
Study Start Date : March 2004
Primary Completion Date : December 2007

Arms and Interventions

Outcome Measures

Primary Outcome Measures :
  1. Response rate
  2. Correlate results of ex vivo/in vitro studies on phenotypic, cytogenetic, and functional disease characteristics with in vivo treatment responses
  3. Identify parameters that are associated with a high probability of response

Eligibility Criteria

Information from the National Library of Medicine

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


  • Diagnosis of myelodysplastic syndromes (MDS)

    • Low- or intermediate-1-risk disease, as defined by International Prognostic Scoring System (IPSS) criteria, meeting 1 of the following criteria:

      • Single or multilineage cytopenia, as defined by all of the following:

        • Absolute neutrophil count < 1,500/mm^3
        • Hemoglobin < 10 g/dL
        • Platelet count < 100,000/mm^3
      • Transfusion requirement of ≥ 2 units of packed red blood cells within an 8-week period
  • Not eligible for stem cell transplantation due to any of the following reasons:

    • No suitable bone marrow donor available
    • Not eligible for a transplantation protocol
    • Not willing to undergo transplantation
  • No intermediate-2- or high-risk MDS
  • No chronic myelomonocytic leukemia



  • 18 and over

Performance status

  • Not specified

Life expectancy

  • Not specified


  • See Disease Characteristics


  • Not specified


  • Not specified


  • No pneumonia within the past 2 weeks


  • Not pregnant or nursing
  • Negative pregnancy test
  • Fertile patients must use effective contraception
  • No other severe disease that would preclude study compliance
  • No other active severe infection (e.g., septicemia) within the past 2 weeks


Biologic therapy

  • More than 4 weeks since prior and no concurrent hematopoietic growth factors for MDS
  • More than 4 weeks since prior immunomodulatory therapy for MDS
  • No prior anti-thymocyte globulin
  • No prior hematopoietic stem cell transplantation
  • No other concurrent immunomodulatory therapy for MDS


  • Not specified

Endocrine therapy

  • Prednisone < 5 mg/day allowed


  • Not specified


  • Not specified


  • More than 4 weeks since prior and no concurrent cytotoxic therapy for MDS
  • More than 4 weeks since prior experimental therapy for MDS
  • No other concurrent experimental therapy for MDS
Contacts and Locations

Information from the National Library of Medicine

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): NCT00217386

United States, Washington
St. Joseph Cancer Center
Bellingham, Washington, United States, 98225-1898
Olympic Medical Center
Port Angeles, Washington, United States, 98362
Seattle Cancer Care Alliance
Seattle, Washington, United States, 98109-1023
Fred Hutchinson Cancer Research Center
Seattle, Washington, United States, 98109-1024
Sponsors and Collaborators
Fred Hutchinson Cancer Research Center
National Cancer Institute (NCI)
Principal Investigator: Bart L. Scott, MD Fred Hutchinson Cancer Research Center
More Information

Responsible Party: Bart L. Scott, Fred Hutchinson Cancer Research Center
ClinicalTrials.gov Identifier: NCT00217386     History of Changes
Other Study ID Numbers: 1872.00
CDR0000430702 ( Registry Identifier: PDQ )
First Posted: September 22, 2005    Key Record Dates
Last Update Posted: September 15, 2010
Last Verified: September 2010

Keywords provided by Fred Hutchinson Cancer Research Center:
de novo myelodysplastic syndromes
previously treated myelodysplastic syndromes
secondary myelodysplastic syndromes
myelodysplastic/myeloproliferative disease, unclassifiable
atypical chronic myeloid leukemia

Additional relevant MeSH terms:
Myelodysplastic Syndromes
Myeloproliferative Disorders
Myelodysplastic-Myeloproliferative Diseases
Pathologic Processes
Bone Marrow Diseases
Hematologic Diseases
Precancerous Conditions
Antilymphocyte Serum
Anti-Inflammatory Agents, Non-Steroidal
Analgesics, Non-Narcotic
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Anti-Inflammatory Agents
Antirheumatic Agents
Gastrointestinal Agents
Immunosuppressive Agents
Immunologic Factors