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Chemotherapy, Low-Dose Total-Body Irradiation, and Peripheral Stem Cell Transplantation Followed By Chemotherapy and Donor Lymphocyte Infusion in Treating Older Patients With Chronic Myeloid Leukemia Clinical Trials Info presented on Clinical Trials Search isn't intended to be a substitute for qualified medical advice, visits or professional assistance by using a real mD. We are not docs. Always confer with your physician about Chemotherapy, Low-Dose Total-Body Irradiation, and Peripheral Stem Cell Transplantation Followed By Chemotherapy and Donor Lymphocyte Infusion in Treating Older Patients With Chronic Myeloid Leukemia conditions. Clinical Trials Search.org is a website committed to listing clinical research studies in human subjects. Chemotherapy, Low-Dose Total-Body Irradiation, and Peripheral Stem Cell Transplantation Followed By Chemotherapy and Donor Lymphocyte Infusion in Treating Older Patients With Chronic Myeloid Leukemia Clinical research trials and Chemotherapy, Low-Dose Total-Body Irradiation, and Peripheral Stem Cell Transplantation Followed By Chemotherapy and Donor Lymphocyte Infusion in Treating Older Patients With Chronic Myeloid Leukemia health trials occur in many 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 effectivity of new does drugs. The intent of the studies / undertakings is to resolve particular human health questions. Clinical trials are a popular way for physicians, government agencies, and private sector companies to detect remedies for all sorts of conditions, including Chemotherapy, Low-Dose Total-Body Irradiation, and Peripheral Stem Cell Transplantation Followed By Chemotherapy and Donor Lymphocyte Infusion in Treating Older Patients With Chronic Myeloid Leukemia. Chemotherapy, Low-Dose Total-Body Irradiation, and Peripheral Stem Cell Transplantation Followed By Chemotherapy and Donor Lymphocyte Infusion in Treating Older Patients With Chronic Myeloid Leukemia Clinical Trials and other clinical trials permit volunteers to obtain healthcare treatment alternatives before they are available to the masses. Most times the participants undergo professional assistance for without cost, and occasionally they are compensated for their time. Occasionally there is a cost for a Chemotherapy, Low-Dose Total-Body Irradiation, and Peripheral Stem Cell Transplantation Followed By Chemotherapy and Donor Lymphocyte Infusion in Treating Older Patients With Chronic Myeloid Leukemia clinical trial. Test subjects typically receive the most expert healthcare available for their Chemotherapy, Low-Dose Total-Body Irradiation, and Peripheral Stem Cell Transplantation Followed By Chemotherapy and Donor Lymphocyte Infusion in Treating Older Patients With Chronic Myeloid Leukemia condition. Dangers are a reality, however, and may include more or frequent mD visits, healthcare dangers (perhaps life-endangering), and/or the treatment being ineffectual. Trials are federally regulated with rigid guidelines to protect clinical trials patients.
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Home > "C" Clinical Trials Conditions > Chemotherapy, Low-Dose Total-Body Irradiation, and Peripheral Stem Cell Transplantation Followed By Chemotherapy and Donor Lymphocyte Infusion in Treating Older Patients With Chronic Myeloid Leukemia  Chemotherapy, Low-Dose Total-Body Irradiation, and Peripheral Stem Cell Transplantation Followed By Chemotherapy and Donor Lymphocyte Infusion in Treating Older Patients With Chronic Myeloid Leukemia
Chemotherapy, Low-Dose Total-Body Irradiation, and Peripheral Stem Cell Transplantation Followed By Chemotherapy and Donor Lymphocyte Infusion in Treating Older Patients With Chronic Myeloid Leukemia
For Condition: Philadelphia chromosome positive chronic myelogenous leukemia,chronic phase chronic myelogenous leukemia,accelerated phase chronic myelogenous 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 and radiation therapy used to kill cancer cells. Sometimes the transplanted cells can be rejected by the body's tissues. Cyclosporine, mycophenolate mofetil, and donor lymphocytes may prevent this from happening. PURPOSE: Phase II trial to study the effectiveness of fludarabine and low-dose total-body irradiation followed by allogeneic stem cell transplantation in treating older patients who have chronic myeloid leukemia.
Details: OBJECTIVES: - Determine whether mixed hematopoietic chimerism can be safely established with fludarabine, low-dose total body irradiation, and allogeneic peripheral blood stem cell transplantation followed by immunosuppression with cyclosporine and mycophenolate mofetil and donor lymphocyte infusion in older patients with chronic or accelerated phase chronic myelogenous leukemia. - Determine whether mixed chimerism can be converted to full donor hematopoietic chimerism with infusions of donor lymphocytes in these patients. OUTLINE: Patients receive fludarabine IV on days -4 to -2 and low-dose total body irradiation followed by allogeneic peripheral blood stem cell transplantation on day 0. Patients receive oral cyclosporine twice daily on days -3 to 56 followed by a taper. Patients also receive oral mycophenolate mofetil twice daily on days 0-27. At least 2 weeks after completion of cyclosporine and mycophenolate mofetil, patients with persistent or progressive disease receive donor lymphocytes IV over 30 minutes. In the absence of active graft-versus-host disease, patients may receive a total of 3 donor lymphocyte infusions at increasing cell doses. Patients are followed weekly until 90 days after the last donor cell infusion, monthly for 6 months, every 6 months for 2 years, and then annually for 3 years. PROJECTED ACCRUAL: A total of 20 patients will be accrued for this study within 3 years.
Eligibility:
Study Type: Interventional, Treatment
Minimum Age/Maximum Age: 66 Years/74 Years
Genders: Both
Protocol Entry Criteria: DISEASE CHARACTERISTICS: - Histologically confirmed chronic myelogenous leukemia in first or second chronic or first accelerated phase - Philadelphia chromosome positive - Must have an HLA genotypically identical sibling (excluding identical twins) - Not in interferon-induced complete or partial cytogenetic remission - May be 65 years of age and under only if ineligible for FHCRC protocols 1092.00 and 767.00 - Patients at high risk of regimen-related toxicity due to pre-existing chronic disease affecting liver, lungs, and heart are considered on a case-by-case basis PATIENT CHARACTERISTICS: Age: - See Disease Characteristics - 66 to 74 Performance status: - Karnofsky 70-100% (Karnofsky 50-100% for patients age 65 and under) Life expectancy: - Not specified Hematopoietic: - Not specified Hepatic: - See Disease Characteristics - Bilirubin no greater than 2 times upper limit of normal (ULN)* - SGOT and SGPT no greater than 2 times ULN (4 times ULN for patients age 65 and under)* NOTE: * Unless due to malignancy Renal: - Renal failure allowed Cardiovascular: - See Disease Characteristics - No poorly controlled hypertension - Cardiac ejection fraction at least 40% (for patients with a history of cardiac disease or anthracycline use) - No history of congestive heart failure (for patients age 65 and under) Pulmonary: - See Disease Characteristics - DLCO at least 50% of predicted - No severe defects in pulmonary function testing* - No supplementary continuous oxygen* NOTE: * For patients age 65 and under Other: - HIV negative - Not pregnant - Fertile patients must use effective contraception during and for 12 months after study participation PRIOR CONCURRENT THERAPY: Biologic therapy: - See Disease Characteristics - At least 1 month since prior interferon alfa Chemotherapy: - Not specified 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
Baylor University Medical Center *Recruiting*
Dallas, Texas, 75246
United States
Recruiting Edward Agura 214-820-1800
University of Torino *Recruiting*
Torino, , 10126
Italy
Recruiting Benedetto Bruno 39-11-633-4418
Stanford Cancer Center at Stanford University Medical Center *Recruiting*
Stanford, California, 94305-5623
United States
Recruiting Judith Shizuru 650-723-0822
Universitaet Leipzig *Recruiting*
Leipzig, , D-04103
Germany
Recruiting Dietger Niederwieser 49-341-971-3050
Fred Hutchinson Cancer Research Center *Recruiting*
Seattle, Washington, 98109-1024
United States
Recruiting Brenda Sandmaier 206-667-4961
Additional Information:
Study ID Numbers: CDR0000065928; FHCRC-1209.00,NCI-G97-1359
Study Start Date:
Record last reviewed: November 2003
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00003145
Other Accelerated Phase Chronic Myelogenous Leukemia Studies:
1. Imatinib Mesylate With or Without Interferon Alfa or Cytarabine Compared With Interferon Alfa Followed by Allogeneic Stem Cell Transplantation in Treating Patients With Newly Diagnosed Chronic Phase Chronic Myelogenous Leukemia
2. Chemotherapy and Biological Therapy in Treating Patients With Chronic Phase Chronic Myelogenous Leukemia
3. Donor Bone Marrow Transplantation in Treating Patients With Hematologic Cancer
4. Imatinib Mesylate and Interferon Alfa in Treating Patients With Chronic Myelogenous Leukemia
5. Arsenic Trioxide in Treating Patients With Relapsed or Refractory Chronic Myelogenous Leukemia
Related Studies:
Other accelerated phase chronic myelogenous leukemia Clinical Trials
Other Clinical Trials
Other Torino Clinical Trials
Chemotherapy, Low-Dose Total-Body Irradiation, and Peripheral Stem Cell Transplantation Followed By Chemotherapy and Donor Lymphocyte Infusion in Treating Older Patients With Chronic Myeloid Leukemia
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