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| Descriptive Information Fields | |||||
| Brief Title † | Chemotherapy and Peripheral Stem Cell Transplantation in Treating Patients With Myelodysplastic Syndrome | ||||
| Official Title † | Allogeneic Peripheral Blood Stem Cell (PBSC) Transplantation for the Treatment of "Less Advanced" Myelodysplasi | ||||
| Brief 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. |
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| Detailed Description | OBJECTIVES:
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. |
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| Study Phase | Phase II | ||||
| Study Type † | Interventional | ||||
| Study Design † | Treatment | ||||
| Primary Outcome Measure † | |||||
| Secondary Outcome Measure † | |||||
| Condition † | Leukemia Myelodysplastic Syndromes |
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| Intervention † | Drug: busulfan Drug: cyclophosphamide Drug: cyclosporine Drug: methotrexate Procedure: allogeneic bone marrow transplantation Procedure: peripheral blood stem cell transplantation |
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| MEDLINE PMIDs | |||||
| Links | Clinical trial summary from the National Cancer Institute's PDQ® database ![]() |
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| Recruitment Information Fields | |||||
| Recruitment Status † | Active, not recruiting | ||||
| Enrollment † | |||||
| Start Date † | February 2001 | ||||
| Completion Date | |||||
| Eligibility Criteria † | DISEASE CHARACTERISTICS:
PATIENT CHARACTERISTICS: Age:
Performance status:
Life expectancy:
Hematopoietic:
Hepatic:
Renal:
Cardiovascular:
Pulmonary:
Other:
PRIOR CONCURRENT THERAPY: Biologic therapy
Chemotherapy
Endocrine therapy
Radiotherapy
Surgery
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| Gender | Both | ||||
| Ages | up to 65 Years | ||||
| Accepts Healthy Volunteers | No | ||||
| Contacts †† | |||||
| Location Countries † | United States | ||||
| Administrative Information Fields | |||||
| NCT ID † | NCT00024050 | ||||
| Organization ID | CDR0000068887 | ||||
| Secondary IDs †† | FHCRC-1536.00, NCI-G01-2009 | ||||
| Study Sponsor † | Fred Hutchinson Cancer Research Center | ||||
| Collaborators †† | National Cancer Institute (NCI) | ||||
| Investigators † |
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| Information Provided By | National Cancer Institute (NCI) | ||||
| Verification Date | October 2003 | ||||
| First Received Date † | September 13, 2001 | ||||
| Last Updated Date | July 23, 2008 | ||||