Granulocyte-Macrophage Colony Stimulating Factor (GM-CSF) After T-Lymphocyte Depleted Allogeneic BMT for Myelodysplastic Syndromes
18 Years
65 Years
Both
Leukemia, Myelodysplastic Syndromes, Myelodysplastic/Myeloproliferative Diseases
Trial Information
Granulocyte-Macrophage Colony Stimulating Factor (GM-CSF) After T-Lymphocyte Depleted Allogeneic BMT for Myelodysplastic Syndromes
OBJECTIVES:
- Determine the effect of sargramostim (GM-CSF) on the progression-free 1-year survival
of patients with myelodysplastic syndrome who have undergone T-cell-depleted CD34+
augmented allogeneic bone marrow transplantation.
OUTLINE: All patients receive elutriated, CD34+ stem cell augmented donor bone marrow
according to another protocol on day 0.
Patients receive sargramostim (GM-CSF) subcutaneously on days 5-60.
Patients are followed on days 120, 180, 360 and periodically thereafter.
PROJECTED ACCRUAL: A total of 45 patients will be accrued for this study within 3-4 years.
Inclusion Criteria
DISEASE CHARACTERISTICS:
- Cytologically proven myelodysplastic syndrome (MDS) of one of the following types:
- Refractory anemia with excess blasts (RAEB)
- RAEB in transformation
- Chronic myelomonocytic leukemia
- MDS with multiple chromosomal abnormalities
- MDS with life threatening cytopenias in at least 2 cell lines
- Platelet count < 30,000/mm^3 OR
- Absolute neutrophil count no greater than 1,000/mm^3 OR
- Anemia requiring transfusion support
- Leukemia out of MDS (meet any of above requirements, but greater than 30% blasts
in marrow)
- No acute leukemia
- Medically eligible for bone marrow transplant according to standard operating
procedure of the Sidney Kimmel Cancer Center at Johns Hopkins Blood and Bone Marrow
Transplant
PATIENT CHARACTERISTICS:
Age:
- 18 to 65
Performance status:
- ECOG 0-1
Life expectancy:
- Not specified
Hematopoietic:
- See Disease Characteristics
Hepatic:
- Not specified
Renal:
- Not specified
Other:
- No prior acute allergic reactions to sargramostim (GM-CSF)
- Not pregnant
- Fertile patients must use effective contraception
PRIOR CONCURRENT THERAPY:
Biologic therapy:
- Not specified
Chemotherapy:
- Not specified
Endocrine therapy:
- Not specified
Radiotherapy:
- Not specified
Surgery:
- Not specified
Type of Study:
Interventional
Study Design:
Masking: Open Label, Primary Purpose: Treatment
Principal Investigator
B. Douglas Smith, MD
Investigator Role:
Principal Investigator
Investigator Affiliation:
Sidney Kimmel Comprehensive Cancer Center
Authority:
United States: Federal Government
Study ID:
CDR0000067160, J9852
NCT ID:
NCT00003961
Start Date:
April 1999
Completion Date:
Related Keywords:
- Leukemia
- Myelodysplastic Syndromes
- Myelodysplastic/Myeloproliferative Diseases
- refractory anemia with excess blasts
- refractory anemia with excess blasts in transformation
- chronic myelomonocytic leukemia
- de novo myelodysplastic syndromes
- previously treated myelodysplastic syndromes
- secondary myelodysplastic syndromes
- refractory cytopenia with multilineage dysplasia
- atypical chronic myeloid leukemia
- myelodysplastic/myeloproliferative disease, unclassifiable
- Leukemia
- Myelodysplastic Syndromes
- Preleukemia
- Myeloproliferative Disorders
- Myelodysplastic-Myeloproliferative Diseases
Name | Location |
|---|---|
| Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins | Baltimore, Maryland 21231-2410 |
