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Study 16 of 2744 for search of: | United States, Louisiana |
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Sponsors and Collaborators: |
Southwest Oncology Group National Cancer Institute (NCI) |
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Information provided by: | National Cancer Institute (NCI) |
ClinicalTrials.gov Identifier: | NCT00053014 |
RATIONALE: Peripheral stem cell transplantation may be able to replace immune cells that were destroyed by chemotherapy and radiation therapy. Sometimes the transplanted cells can make an immune response against the body's normal tissues. Cyclosporine and mycophenolate mofetil may prevent this from happening.
PURPOSE: Phase II trial to study the effectiveness of chemotherapy and total-body irradiation followed by donor peripheral stem cell transplantation, cyclosporine, and mycophenolate mofetil in treating older patients who have acute myeloid leukemia.
Condition | Intervention | Phase |
---|---|---|
Leukemia |
Drug: cyclosporine Drug: fludarabine phosphate Drug: mycophenolate mofetil Drug: therapeutic allogeneic lymphocytes Procedure: peripheral blood stem cell transplantation Procedure: radiation therapy |
Phase II |
Study Type: | Interventional |
Study Design: | Treatment, Open Label |
Official Title: | A Phase II Study Of Chimerism-Mediated Immunotherapy (CMI) Using Nonmyeloablative Allogeneic Peripheral Blood Stem Cell Transplantation In Older Patients With Acute Myeloid Leukemia (AML) In First Complete Remission (A BMT Study) |
Study Start Date: | April 2003 |
OBJECTIVES:
OUTLINE: This is an open-label study.
Patients are followed every 3 months for 1 year, every 6 months for 1 year, and then annually for 3 years.
PROJECTED ACCRUAL: A total of 25-51 patients will be accrued for this study.
Ages Eligible for Study: | 55 Years to 69 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
DISEASE CHARACTERISTICS:
PATIENT CHARACTERISTICS:
Age
Performance status
Life expectancy
Hematopoietic
Hepatic
Renal
Other
No other malignancy within the past 2 years except for the following:
PRIOR CONCURRENT THERAPY:
Biologic therapy
Chemotherapy
Endocrine therapy
Radiotherapy
Surgery
Study Chair: | Peter McSweeney, MD | Rocky Mountain Cancer Centers - Denver Midtown |
Study ID Numbers: | CDR0000269049, SWOG-S0125 |
Study First Received: | January 27, 2003 |
Last Updated: | July 23, 2008 |
ClinicalTrials.gov Identifier: | NCT00053014 |
Health Authority: | United States: Federal Government |
adult acute myeloid leukemia in remission adult acute myeloid leukemia with t(8;21)(q22;q22) adult acute myeloid leukemia with t(16;16)(p13;q22) adult acute myeloid leukemia with inv(16)(p13;q22) adult acute myeloid leukemia with 11q23 (MLL) abnormalities |
Cyclosporine Clotrimazole Miconazole Tioconazole Acute myelogenous leukemia Leukemia, Myeloid Fludarabine monophosphate Leukemia, Myeloid, Acute |
Cyclosporins Leukemia Mycophenolate mofetil Acute myeloid leukemia, adult Fludarabine Congenital Abnormalities Acute myelocytic leukemia |
Antimetabolites Anti-Infective Agents Antimetabolites, Antineoplastic Neoplasms by Histologic Type Molecular Mechanisms of Pharmacological Action Immunologic Factors Antineoplastic Agents Physiological Effects of Drugs |
Enzyme Inhibitors Immunosuppressive Agents Pharmacologic Actions Neoplasms Antifungal Agents Therapeutic Uses Antirheumatic Agents Dermatologic Agents |