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Biological Therapy in Treating Patients With Myelodysplastic Syndrome

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ClinicalTrials.gov Identifier: NCT00005853
Recruitment Status : Completed
First Posted : January 27, 2003
Last Update Posted : April 2, 2010
National Cancer Institute (NCI)
Information provided by:
Fred Hutchinson Cancer Research Center

Brief Summary:

RATIONALE: Biological therapies use different ways to stimulate the immune system and stop cancer cells from growing. Combining different types of biological therapies may kill more cancer cells.

PURPOSE: Phase II trial to study the effectiveness of biological therapy in treating patients who have myelodysplastic syndrome.

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

Detailed Description:


  • Determine the frequency of hematologic responses in patients with myelodysplastic syndrome treated with anti-thymocyte globulin and tumor necrosis factor receptor IgG chimera.
  • Correlate phenotypic, cytogenetic, and functional disease characteristics with treatment responses in these patients.
  • Determine the safety of this treatment regimen in this patient population.

OUTLINE: Patients receive anti-thymocyte globulin IV over 8 hours daily for 4 days followed by tumor necrosis factor receptor IgG chimera subcutaneously twice weekly for 16 weeks.

Patients are followed at 8, 16, and 20 weeks.

PROJECTED ACCRUAL: A total of 15 patients will be accrued for this study.

Study Type : Interventional  (Clinical Trial)
Primary Purpose: Treatment
Official Title: Therapy of Myelodysplastic Syndrome (MDS) With Antithymocyte Globulin (ATG) and TNFR:Fc
Study Start Date : December 1999
Primary Completion Date : August 2005
Study Completion Date : August 2005

Information from the National Library of Medicine

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Ages Eligible for Study:   Child, Adult, Senior
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No


  • Diagnosis of myelodysplastic syndrome with no greater than 20% marrow blasts with:

    • Single or multilineage cytopenia (neutrophils less than 2,000/mm^3 and/or platelet count less than 100,000/mm^3 and/or reticulocyte count less than 18,000/mm^3) OR
    • Transfusion requirement of at least 2 units packed red blood cells per month and one of the following:

      • Suitable marrow donor unavailable
      • Ineligible for a transplantation protocol
      • Unwilling to proceed with transplantation
  • No chronic myelomonocytic leukemia



  • Any age

Performance status:

  • Not specified

Life expectancy:

  • Not specified


  • See Disease Characteristics


  • Not specified


  • Not specified


  • No other severe disease that would preclude study
  • No active severe infection (e.g., pneumonia or septicemia) or severe infections within the past 2 weeks


Biologic therapy:

  • See Disease Characteristics
  • At least 4 weeks since prior hematopoietic growth factors
  • No concurrent hematopoietic growth factors


  • At least 4 weeks since prior cytotoxic therapy
  • No concurrent cytotoxic therapy

Endocrine therapy:

  • Not specified

Radiation therapy:

  • Not specified


  • Not specified


  • At least 4 weeks since prior immunomodulatory therapy
  • No concurrent immunomodulatory therapy

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): NCT00005853

United States, Washington
Fred Hutchinson Cancer Research Center
Seattle, Washington, United States, 98109
Sponsors and Collaborators
Fred Hutchinson Cancer Research Center
National Cancer Institute (NCI)
Study Chair: H. Joachim Deeg, MD Fred Hutchinson Cancer Research Center

ClinicalTrials.gov Identifier: NCT00005853     History of Changes
Other Study ID Numbers: 1478.00
CDR0000067878 ( Registry Identifier: PDQ )
First Posted: January 27, 2003    Key Record Dates
Last Update Posted: April 2, 2010
Last Verified: March 2010

Keywords provided by Fred Hutchinson Cancer Research Center:
refractory anemia
refractory anemia with ringed sideroblasts
refractory anemia with excess blasts
refractory anemia with excess blasts in transformation
de novo myelodysplastic syndromes
previously treated myelodysplastic syndromes
secondary myelodysplastic syndromes
refractory cytopenia with multilineage dysplasia
childhood myelodysplastic syndromes

Additional relevant MeSH terms:
Myelodysplastic Syndromes
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