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

This study has been completed.
National Cancer Institute (NCI)
Information provided by:
Fred Hutchinson Cancer Research Center Identifier:
First received: September 20, 2005
Last updated: September 13, 2010
Last verified: September 2010

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 Intervention Phase
Myelodysplastic Syndromes
Myelodysplastic/Myeloproliferative Diseases
Biological: anti-thymocyte globulin
Biological: etanercept
Phase 2

Study Type: Interventional
Study Design: Masking: Open Label
Primary Purpose: Treatment
Official Title: Therapy of Early Stage Myelodysplastic Syndrome (MDS) With ATG and Etanercept

Resource links provided by NLM:

Further study details as provided by Fred Hutchinson Cancer Research Center:

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

Estimated Enrollment: 30
Study Start Date: March 2004
Primary Completion Date: December 2007 (Final data collection date for primary outcome measure)
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.


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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its identifier: 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 Identifier: NCT00217386     History of Changes
Other Study ID Numbers: 1872.00
CDR0000430702 ( Registry Identifier: PDQ )
Study First Received: September 20, 2005
Last Updated: September 13, 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
Immunologic Factors
Physiological Effects of Drugs
Immunosuppressive Agents
Anti-Inflammatory Agents, Non-Steroidal
Analgesics, Non-Narcotic
Sensory System Agents
Peripheral Nervous System Agents
Anti-Inflammatory Agents
Antirheumatic Agents
Gastrointestinal Agents processed this record on May 25, 2017