Therapy of Myelodysplastic Syndrome (MDS) With Antithymocyte Globulin (ATG) and TNFR:Fc
N/A
N/A
Both
Leukemia, Myelodysplastic Syndromes
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 Center | Seattle, Washington 98109 |
