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Peripheral Stem Cell Transplantation in Treating Older Patients With Acute Myeloid Leukemia Clinical Trials Resources presented on Clinical Trials Search is not meant to be a substitute for proven health advice, calls or treatment with a real medical. We aren't mDs. Always consult your doctor on Peripheral Stem Cell Transplantation in Treating Older Patients With Acute Myeloid Leukemia conditions. Clinical Trials Search.org is a website dedicated to listing clinical research studies in human subjects. Peripheral Stem Cell Transplantation in Treating Older Patients With Acute Myeloid Leukemia Clinical research trials and Peripheral Stem Cell Transplantation in Treating Older Patients With Acute Myeloid Leukemia healthcare trials take place in a lot of of localities throughout the U.S.. A clinical trial or clinical study is a research project with human volunteer subjects. Clinical drug trials and pharmaceutical clinical trials typically assess the effectiveness of new does drugs. The function of the studies / projects is to figure out specific human medical questions. Clinical trials are a popular means for doctors, government agencies, and private sector corporations to find cures for all varieties of conditions, like Peripheral Stem Cell Transplantation in Treating Older Patients With Acute Myeloid Leukemia. Peripheral Stem Cell Transplantation in Treating Older Patients With Acute Myeloid Leukemia Clinical Trials and other clinical trials allow volunteers to access health treatment options before they are available to the masses. Many times the subjects receive professional assistance for free, and every now and again they are compensated for their time. Sometimes there is a cost for a Peripheral Stem Cell Transplantation in Treating Older Patients With Acute Myeloid Leukemia clinical trial. Human subjects often obtain the finest healthcare possible for their Peripheral Stem Cell Transplantation in Treating Older Patients With Acute Myeloid Leukemia condition. Hazards are a reality, nevertheless, and might include additional or frequent dr. calls, health hazards (potentially life-jeopardizing), and/or the treatment being uneffective. Trials are federally regulated with stern guidelines to protect clinical trials patients.
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Home > "P" Clinical Trials Conditions > Peripheral Stem Cell Transplantation in Treating Older Patients With Acute Myeloid Leukemia  Peripheral Stem Cell Transplantation in Treating Older Patients With Acute Myeloid Leukemia
Peripheral Stem Cell Transplantation in Treating Older Patients With Acute Myeloid Leukemia
For Condition: adult acute monocytic leukemia,secondary acute myeloid leukemia,adult acute myeloid 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 or radiation therapy. Sometimes the transplanted cells may make an immune response against the body's normal tissues. Treatment with cyclosporine and mycophenolate mofetil may prevent this from happening. PURPOSE: Phase II trial to study the effectiveness of donor peripheral stem cell transplantation in treating older patients who have acute myeloid leukemia.
Details: OBJECTIVES: - Determine whether a 1-year disease-free survival of at least 35% can be achieved among older patients with de novo or secondary acute myeloid leukemia in first complete remission treated with nonmyeloablative allogeneic peripheral blood stem cell transplantation. - Determine whether a day 200 nonrelapse-related mortality of less than 15% can be achieved among patients treated with this regimen. - Determine the 1-year overall survival, incidence of relapse, and incidence of graft rejection in patients treated with this regimen. - Determine the incidence of acute and chronic graft-vs-host disease in patients treated with this regimen. OUTLINE: This is a multicenter study. Patients receive fludarabine IV on days -4 to -2. Patients undergo total body irradiation followed by allogeneic peripheral blood stem cell infusion on day 0. Patients receive oral cyclosporine twice daily on days -3 to 56 followed by a taper on days 57-77 and oral mycophenolate mofetil twice daily on days 0-27. Patients are followed every 6 months for 2 years and then annually for 5 years. PROJECTED ACCRUAL: A total of 40 patients will be accrued for this study within 4 years.
Eligibility:
Study Type: Interventional, Treatment
Minimum Age/Maximum Age: 55 Years/
Genders: Both
Protocol Entry Criteria: DISEASE CHARACTERISTICS: - Diagnosis of de novo acute myeloid leukemia (AML) (FAB M0-M2, M4-M7) OR secondary AML in first complete remission after prior induction chemotherapy and 1 or 2 courses of prior consolidation chemotherapy - Transplantation conditioning must occur within 6 months of diagnosis - No involvement of CNS by positive cytospin of cerebrospinal fluid - Availability of a related donor who is genotypically or phenotypically identical - No identical twins PATIENT CHARACTERISTICS: Age - 55 and over Performance status - Karnofsky 70-100% Life expectancy - Not specified Hematopoietic - Not specified Hepatic - No fulminant liver failure - No alcoholic hepatitis - No hepatic encephalopathy grade II or greater - No hepatic synthetic dysfunction evidenced by prolongation of PT with an INR greater than 2.5 - No intractable ascites related to portal hypertension - No bacterial or fungal liver abscess - No chronic viral hepatitis with bilirubin greater than 5 mg/dL - No biliary obstruction with bilirubin greater than 5 mg/dL - No concurrent symptomatic biliary disease Renal - Not specified Cardiovascular - Cardiac ejection fraction at least 40% Pulmonary - DLCO corrected at least 40% - No requirement for supplemental oxygen - Pulmonary nodules allowed if approved by the principal investigator Other - HIV negative - No fungal infections with radiographic progression after treatment with amphotericin B or active triazole for more than 1 month - No history of bleeding esophageal varices - Not pregnant or nursing - Fertile patients must use effective contraception during and for 1 year after study participation PRIOR CONCURRENT THERAPY: Biologic therapy - No concurrent growth factors on days 0-27 of study therapy Chemotherapy - See Disease Characteristics Endocrine therapy - Not specified Radiotherapy - Not specified Surgery - Not specified
Total Enrollment:
Location and Contact Information:
Overall Study Official:
BrendaSandmaier, Study Chair, Fred Hutchinson Cancer Research Center
Huntsman Cancer Institute *Recruiting*
Salt Lake City, Utah, 84112
United States
Recruiting Michael Pulsipher 801-585-3229
Fred Hutchinson Cancer Research Center *Recruiting*
Seattle, Washington, 98109-1024
United States
Recruiting Brenda Sandmaier 206-667-4961
Cancer Institute at Oregon Health and Science University *Recruiting*
Portland, Oregon, 97239
United States
Recruiting Elliot Epner 503-494-1551
Additional Information:
Study ID Numbers: CDR0000256466; NCI-H02-0094,FHCRC-1654.00
Study Start Date:
Record last reviewed: March 2004
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00045435
Other Adult Acute Monocytic Leukemia Studies:
1. Daunorubicin and Cytarabine With or Without Zosuquidar Trihydrochloride in Treating Older Patients With Newly Diagnosed Acute Myeloid Leukemia or Refractory Anemia
2. Combination Chemotherapy With or Without Monoclonal Antibody Therapy Followed by Stem Cell Transplantation in Treating Patients With Acute Myeloid Leukemia
3. Chemotherapy With or Without Gemtuzumab Ozogamicin in Treating Older Patients With Acute Myeloid Leukemia
4. Combination Chemotherapy With or Without Filgrastim and/or Tretinoin in Treating Patients With Acute Myeloid Leukemia
5. Combination Chemotherapy, Interleukin-2, and Peripheral Stem Cell Transplantation in Treating Patients With Acute Myeloid Leukemia
Related Studies:
Other adult acute monocytic leukemia Clinical Trials
Other Utah Clinical Trials
Other Salt Lake City Clinical Trials
Peripheral Stem Cell Transplantation in Treating Older Patients With Acute Myeloid Leukemia
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