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Therapy of Myelodysplastic Syndrome (MDS) With Antithymocyte Globulin (ATG) and TNFR:Fc


Phase 2
N/A
N/A
Not Enrolling
Both
Leukemia, Myelodysplastic Syndromes

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Trial Information

Therapy of Myelodysplastic Syndrome (MDS) With Antithymocyte Globulin (ATG) and TNFR:Fc


OBJECTIVES:

- 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.

Inclusion Criteria


DISEASE CHARACTERISTICS:

- 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

PATIENT CHARACTERISTICS:

Age:

- Any age

Performance status:

- Not specified

Life expectancy:

- Not specified

Hematopoietic:

- See Disease Characteristics

Hepatic:

- Not specified

Renal:

- Not specified

Other:

- 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

PRIOR CONCURRENT THERAPY:

Biologic therapy:

- See Disease Characteristics

- At least 4 weeks since prior hematopoietic growth factors

- No concurrent hematopoietic growth factors

Chemotherapy:

- At least 4 weeks since prior cytotoxic therapy

- No concurrent cytotoxic therapy

Endocrine therapy:

- Not specified

Radiation therapy:

- Not specified

Surgery:

- Not specified

Other:

- At least 4 weeks since prior immunomodulatory therapy

- No concurrent immunomodulatory therapy

Type of Study:

Interventional

Study Design:

Primary Purpose: Treatment

Principal Investigator

H. Joachim Deeg, MD

Investigator Role:

Study Chair

Investigator Affiliation:

Fred Hutchinson Cancer Research Center

Authority:

United States: Federal Government

Study ID:

1478.00

NCT ID:

NCT00005853

Start Date:

December 1999

Completion Date:

August 2005

Related Keywords:

  • Leukemia
  • Myelodysplastic Syndromes
  • 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
  • Leukemia
  • Myelodysplastic Syndromes
  • Preleukemia

Name

Location

Fred Hutchinson Cancer Research CenterSeattle, Washington  98109