Myelodysplastic Syndrome Clinical Trial
Chemotherapy and Peripheral Stem Cell Transplantation in Treating Patients With Myelodysplastic Syndrome
Summary
RATIONALE: Drugs used in chemotherapy use different ways to stop cancer cells from dividing so they stop growing or die. Peripheral stem cell transplantation may be able to replace immune cells that were destroyed by chemotherapy.
PURPOSE: Phase II trial to study the effectiveness of chemotherapy followed by peripheral stem cell transplantation in treating patients who have myelodysplastic syndrome.
Full Description
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.
Eligibility 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
Check Your Eligibility
Let’s see if you might be eligible for this study.
What is your age and gender ?
There is 1 Location for this study
Seattle Washington, 98109, United States
How clear is this clinincal trial information?
Please confirm you are a US based health care provider:
Yes, I am a health care Provider No, I am not a health care providerSign Up Now.
Take Control of Your Disease Journey.
Sign up now for expert patient guides, personalized treatment options, and cutting-edge insights that can help you push for the best care plan.