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Chemotherapy and Peripheral Stem Cell Transplantation in Treating Patients With Myelodysplastic Syndrome Clinical Trials Facts presented on Clinical Trials Search is not designed to be a substitute for certified medical advice, travels to or professional assistance by using a genuine doctor. We aren't mDs. Always consult your physician about Chemotherapy and Peripheral Stem Cell Transplantation in Treating Patients With Myelodysplastic Syndrome conditions. Clinical Trials Search.org is a website committed to listing clinical research studies in human subjects. Chemotherapy and Peripheral Stem Cell Transplantation in Treating Patients With Myelodysplastic Syndrome Clinical research trials and Chemotherapy and Peripheral Stem Cell Transplantation in Treating Patients With Myelodysplastic Syndrome health trials occur in a lot of of cities throughout the US. A clinical trial or clinical study is a research project with human volunteer subjects. Clinical drug trials and pharmaceutical clinical trials generally evaluate the potency of new does drugs. The role of the studies / undertakings is to figure out specific human healthcare questions. Clinical trials are a popular manner for mDs, government agencies, and private sector companies to locate treatments for all sorts of conditions, including Chemotherapy and Peripheral Stem Cell Transplantation in Treating Patients With Myelodysplastic Syndrome. Chemotherapy and Peripheral Stem Cell Transplantation in Treating Patients With Myelodysplastic Syndrome Clinical Trials and other clinical trials permit volunteers to get medical treatment choices before they are available to the general public. Many times the test subjects get professional assistance for free of charge, and occasionally they are compensated for their time. Sometimes there is a cost for a Chemotherapy and Peripheral Stem Cell Transplantation in Treating Patients With Myelodysplastic Syndrome clinical trial. Human subjects often get the best healthcare possible for their Chemotherapy and Peripheral Stem Cell Transplantation in Treating Patients With Myelodysplastic Syndrome condition. Risks are a reality, nevertheless, and could include additional or frequent dr. calls, medical hazards (perhaps life-threatening), and/or the treatment being ineffectual. Trials are federally governed with exacting guidelines to protect clinical trials patients.
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Home > "C" Clinical Trials Conditions > Chemotherapy and Peripheral Stem Cell Transplantation in Treating Patients With Myelodysplastic Syndrome  Chemotherapy and Peripheral Stem Cell Transplantation in Treating Patients With Myelodysplastic Syndrome
Chemotherapy and Peripheral Stem Cell Transplantation in Treating Patients With Myelodysplastic Syndrome
For Condition: secondary myelodysplastic syndromes,Refractory Anemia,previously treated myelodysplastic syndromes,refractory anemia with ringed sideroblasts,de novo myelodysplastic syndromes
Status: Recruiting
Sponsor(s): Fred Hutchinson Cancer Research Center , National Cancer Institute (NCI)
Synopsis: 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.
Details: 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:
Study Type: Interventional, Treatment
Minimum Age/Maximum Age: /65 Years
Genders: Both
Protocol Entry 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
Total Enrollment:
Location and Contact Information:
Overall Study Official:
H.Deeg, Study Chair, Fred Hutchinson Cancer Research Center
Fred Hutchinson Cancer Research Center *Recruiting*
Seattle, Washington, 98109
United States
Recruiting H. Deeg 206-667-5985
Additional Information:
Study ID Numbers: CDR0000068887; FHCRC-1536.00,NCI-G01-2009
Study Start Date:
Record last reviewed: September 2001
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00024050
Other Refractory Anemia Studies:
1. Antithymocyte Globulin and Cyclosporine Compared With Standard Therapy in Treating Patients With Myelodysplastic Syndrome
2. Combination Chemotherapy in Treating Children With Newly Diagnosed Acute Myeloid Leukemia or Myelodysplastic Syndrome
3. Combination Chemotherapy With or Without Bone Marrow Transplantation in Treating Children With Acute Myelogenous Leukemia or Myelodysplastic Syndrome
4. Gemtuzumab in Treating Patients With Myelodysplastic Syndrome
5. Chemotherapy and Peripheral Stem Cell Transplantation in Treating Patients With Myelodysplastic Syndrome
Related Studies:
Other Refractory Anemia Clinical Trials
Other Washington Clinical Trials
Other Seattle Clinical Trials
Chemotherapy and Peripheral Stem Cell Transplantation in Treating Patients With Myelodysplastic Syndrome
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