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Donor Peripheral Stem Cell Transplantation in Treating Patients With Myelodysplastic Syndrome, Acute Myeloid Leukemia, or Myeloproliferative Disorder Clinical Trials Data presented on Clinical Trials Search isn't meant to be a substitute for qualified health advice, calls or treatment using a genuine doctor. We are not docs. Always consult your dr. on Donor Peripheral Stem Cell Transplantation in Treating Patients With Myelodysplastic Syndrome, Acute Myeloid Leukemia, or Myeloproliferative Disorder conditions. Clinical Trials Search.org is a site dedicated to listing clinical research studies in human subjects. Donor Peripheral Stem Cell Transplantation in Treating Patients With Myelodysplastic Syndrome, Acute Myeloid Leukemia, or Myeloproliferative Disorder Clinical research trials and Donor Peripheral Stem Cell Transplantation in Treating Patients With Myelodysplastic Syndrome, Acute Myeloid Leukemia, or Myeloproliferative Disorder healthcare trials occur in a lot of of places throughout the United States. A clinical trial or clinical study is a research project with human volunteer subjects. Clinical drug trials and pharmaceutical clinical trials generally assess the potency of new drugs. The intent of the studies / undertakings is to figure out certain human medical questions. Clinical trials are a popular means for mDs, government agencies, and private sector corporations to locate remedies for all kinds of circumstances, including Donor Peripheral Stem Cell Transplantation in Treating Patients With Myelodysplastic Syndrome, Acute Myeloid Leukemia, or Myeloproliferative Disorder. Donor Peripheral Stem Cell Transplantation in Treating Patients With Myelodysplastic Syndrome, Acute Myeloid Leukemia, or Myeloproliferative Disorder Clinical Trials and other clinical trials allow volunteers to obtain health treatment alternatives before they are available to the masses. Many times the participants undergo treatment for free, and sometimes they are paid for their time. Occasionally there is a cost for a Donor Peripheral Stem Cell Transplantation in Treating Patients With Myelodysplastic Syndrome, Acute Myeloid Leukemia, or Myeloproliferative Disorder clinical trial. Participants typically obtain the most effective healthcare available for their Donor Peripheral Stem Cell Transplantation in Treating Patients With Myelodysplastic Syndrome, Acute Myeloid Leukemia, or Myeloproliferative Disorder condition. Dangers are a reality, nonetheless, and can include extra or frequent mD trips, medical hazards (potentially life-endangering), and/or the treatment being uneffective. Trials are federally regulated with rigid guidelines to protect clinical trials patients.
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Home > "D" Clinical Trials Conditions > Donor Peripheral Stem Cell Transplantation in Treating Patients With Myelodysplastic Syndrome, Acute Myeloid Leukemia, or Myeloproliferative Disorder  Donor Peripheral Stem Cell Transplantation in Treating Patients With Myelodysplastic Syndrome, Acute Myeloid Leukemia, or Myeloproliferative Disorder
Donor Peripheral Stem Cell Transplantation in Treating Patients With Myelodysplastic Syndrome, Acute Myeloid Leukemia, or Myeloproliferative Disorder
For Condition: chronic myeloproliferative disorders,myelodysplastic and myeloproliferative disease,chronic leukemia,atypical chronic myeloid leukemia,acute leukemia
Status: Recruiting
Sponsor(s): Fred Hutchinson Cancer Research Center , National Cancer Institute (NCI)
Synopsis: RATIONALE: Peripheral stem cell transplantation may be able to replace immune cells that were destroyed by chemotherapy used to kill cancer cells. Sometimes the transplanted cells can make an immune response against the body's normal tissues. Methotrexate and cyclosporine may prevent this from happening. PURPOSE: Phase I/II trial to study the effectiveness of donor peripheral stem cell transplantation in treating patients who have myelodysplastic syndrome, acute myeloid leukemia, or myeloproliferative disorder.
Details: OBJECTIVES: - Determine the incidence of grades II, III, and IV graft-vs-host disease (GVHD) in patients with myelodysplastic syndromes (MDS), acute myeloid leukemia transformed from MDS, or myeloproliferative disorders treated with immunologically engineered, filgrastim (G-CSF)-mobilized, allogeneic peripheral blood stem cell transplantation. - Determine the incidence of graft failure, relapse, and transplant-related mortality by day 100, in patients treated with this regimen. - Determine the incidence of chronic GVHD, in terms of number and duration of immunosuppressant therapies, in patients treated with this regimen. - Determine the feasibility of partial T cell depletion in G-CSF-mobilized peripheral blood stem cells. OUTLINE: Patients receive conditioning with oral busulfan every 6 hours on days -7 to -4 and cyclophosphamide IV on days -3 and -2. Immunologically engineered, filgrastim (G-CSF)-mobilized, allogeneic peripheral blood stem cells are infused on day 0. Patients receive graft vs host disease prophylaxis comprising methotrexate IV on days 1, 3, 6, and 11 and cyclosporine IV over 1-4 hours (orally twice daily when tolerated) on days -1 to 80 and then gradually tapered over 5 months beginning on day 81. Patients are followed regularly through day 100 and then at 1 year. PROJECTED ACCRUAL: A total of 30 patients will be accrued for this study within 3 years.
Eligibility:
Study Type: Interventional, Treatment
Minimum Age/Maximum Age: 18 Years/55 Years
Genders: Both
Protocol Entry Criteria: DISEASE CHARACTERISTICS: - Diagnosis of 1 of the following: - Myelodysplastic syndromes (MDS) that has advanced beyond refractory anemia (RA) - RA with excess blasts (RAEB) (greater than 5% blasts) - RAEB in transformation (greater than 20% but less than 30% blasts) - Acute myeloid leukemia (greater than 30% blasts) that evolved from MDS - Myeloproliferative disorder, including myelofibrosis, chronic myelomonocytic leukemia, agnogenic myeloid metaplasia, polycythemia vera, or essential thrombosis - No chronic myelogenous leukemia with or without excess (greater than 5%) blasts - Must have an HLA-identical, related donor PATIENT CHARACTERISTICS: Age - 18 to 55 Performance status - Not specified Life expectancy - At least 6 months Hematopoietic - Not specified Hepatic - Bilirubin less than 2 times upper limit of normal (ULN)* - SGOT/SGPT less than 2 times ULN* NOTE: * Unless due to malignancy Renal - Creatinine no greater than 2.0 mg/dL OR - Glomerular filtration rate at least 60 mL/min Cardiovascular - Cardiac ejection fraction at least 45% Pulmonary - DLCO at least 60% of predicted Other - HIV negative - Human antimouse antibody negative - Not pregnant or nursing - Fertile patients must use effective contraception PRIOR CONCURRENT THERAPY: Biologic therapy - No other concurrent marrow transplantation - No concurrent growth factors for 21 days after study transplantation Chemotherapy - Not specified Endocrine therapy - Not specified Radiotherapy - Not specified Surgery - Not specified
Total Enrollment:
Location and Contact Information:
Overall Study Official:
AnnWoolfrey, Study Chair, Fred Hutchinson Cancer Research Center
Fred Hutchinson Cancer Research Center *Recruiting*
Seattle, Washington, 98104
United States
Recruiting Ann Woolfrey 206-667-4453
Additional Information:
Study ID Numbers: CDR0000258137; NCI-H02-0099,FHCRC-1628.00
Study Start Date:
Record last reviewed: November 2002
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00049634
Other Atypical Chronic Myeloid Leukemia Studies:
1. Monoclonal Antibody Plus Interleukin-2 in Treating Patients With Leukemia or Lymphoma
2. VNP40101M and Hydroxyurea in Treating Patients With Acute Myeloid Leukemia or High-Risk Myelodysplasia
3. 3-AP and Cytarabine in Treating Patients With Hematologic Cancer
4. Interleukin-2 in Treating Patients With Myelodysplastic Syndrome
5. Vaccine Therapy Plus Immune Adjuvant in Treating Patients With Chronic Myeloid Leukemia, Acute Myeloid Leukemia, or Myelodysplastic Syndrome
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Donor Peripheral Stem Cell Transplantation in Treating Patients With Myelodysplastic Syndrome, Acute Myeloid Leukemia, or Myeloproliferative Disorder
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