Allogeneic Peripheral Blood Stem Cell (PBSC) Transplantation for the Treatment of "Less Advanced" Myelodysplasi
N/A
65 Years
Both
Leukemia, Myelodysplastic Syndromes
Trial Information
Allogeneic Peripheral Blood Stem Cell (PBSC) Transplantation for the Treatment of "Less Advanced" Myelodysplasi
OBJECTIVES:
- Determine the non-relapse toxicity and mortality on day 100 and at 1 year after
transplantation in patients with low or intermediate-risk myelodysplastic syndrome
treated with busulfan, cyclophosphamide, and allogeneic peripheral blood stem cell
transplantation.
- Determine the incidence of donor stem cell engraftment and relapse-free survival in
these patients treated with this regimen.
- Determine the incidence and severity of acute and chronic graft-versus-host disease and
invasive fungal infections in these patients treated with this regimen.
- Determine the incidence of relapse in these patients treated with this regimen.
OUTLINE: Peripheral blood stem cells (PBSC) or bone marrow are harvested from a related or
unrelated compatible donor. PBSC are selected for CD34+ cells.
Patients receive oral busulfan every 6 hours on days -7 to -4 and cyclophosphamide IV on
days -3 and -2. Allogeneic PBSC or bone marrow is infused on day 0.
As graft-versus-host disease prophylaxis, patients receive cyclosporine IV beginning on day
-1 and continuing orally twice daily (if feasible) until day 51 followed by a taper.
Patients also receive methotrexate IV on days 1, 3, 6, and 11.
Patients are followed through day 100, every 6 months for 2 years, and then annually
thereafter.
PROJECTED ACCRUAL: A total of 40 patients will be accrued for this study within 3 years.
Inclusion Criteria
DISEASE CHARACTERISTICS:
- Diagnosis of low or intermediate-risk myelodysplastic syndrome
- Refractory anemia (RA)
- RA with ringed sideroblasts
- No advanced myelodysplastic syndrome (i.e., at least 5% blasts in the marrow, more
than 1% blasts in the peripheral blood, or blasts in the cerebrospinal fluid)
- No poor-risk cytogenetics (i.e., abnormalities of chromosome 7 or complex
abnormalities)
- HLA-A, B, C, DRB1, and DQB1 compatible related or unrelated donor available
- Mismatch for a single HLA-A, B, C, DRB1, or DQB1 allele allowed
PATIENT CHARACTERISTICS:
Age:
- 65 and under
Performance status:
- Not specified
Life expectancy:
- Not specified
Hematopoietic:
- Not specified
Hepatic:
- AST no greater than 2 times normal
Renal:
- Creatinine no greater than 2 times upper limit of normal
- Creatinine clearance at least 50%
Cardiovascular:
- No cardiac insufficiency requiring treatment
- No symptomatic coronary artery disease
Pulmonary:
- No severe hypoxemia (pO2 less than 70 mm Hg with DLCO less than 70% predicted)
- No mild hypoxemia (pO2 less than 80 mm Hg with DLCO less than 60% predicted)
Other:
- No other disease that would limit life expectancy
- HIV negative
- Not pregnant or nursing
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:
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:
1536.00
NCT ID:
NCT00024050
Start Date:
February 2001
Completion Date:
August 2007
Related Keywords:
- Leukemia
- Myelodysplastic Syndromes
- refractory anemia
- refractory anemia with ringed sideroblasts
- de novo myelodysplastic syndromes
- previously treated myelodysplastic syndromes
- secondary myelodysplastic syndromes
- childhood myelodysplastic syndromes
- Leukemia
- Myelodysplastic Syndromes
- Preleukemia
Name | Location |
|---|---|
| Fred Hutchinson Cancer Research Center | Seattle, Washington 98109 |
