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Sponsored by: |
Simmons Cancer Center |
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Information provided by: | National Cancer Institute (NCI) |
ClinicalTrials.gov Identifier: | NCT00044954 |
RATIONALE: Radiation therapy uses high-energy x-rays to damage cancer cells. Drugs used in chemotherapy use different ways to stop cancer cells from dividing so they stop growing or die. Combining chemotherapy with donor peripheral stem cell transplantation may allow the doctor to give higher doses of chemotherapy drugs and kill more tumor cells.
PURPOSE: Phase II trial to study the effectiveness of combining total-body irradiation with fludarabine and donor peripheral stem cell transplantation in treating patients who have hematologic cancer.
Condition | Intervention | Phase |
---|---|---|
Leukemia Lymphoma Multiple Myeloma and Plasma Cell Neoplasm Myelodysplastic Syndromes Myelodysplastic/Myeloproliferative Diseases |
Drug: cyclosporine Drug: fludarabine phosphate Drug: mycophenolate mofetil Drug: therapeutic allogeneic lymphocytes Procedure: allogeneic bone marrow transplantation Procedure: peripheral blood stem cell transplantation Procedure: radiation therapy |
Phase II |
Study Type: | Interventional |
Study Design: | Treatment, Open Label |
Official Title: | Low Dose Total-Body Irradiation And Fludarabine Followed By HLA Matched Allogeneic Stem Cell Transplantation For Hematologic Malgnancies - A Multi-Center Study |
Study Start Date: | November 2001 |
OBJECTIVES:
OUTLINE: This is a multicenter study. Patients are assigned to 1 of 2 groups (high-risk vs low-risk hematologic malignancy). The high-risk group includes acute myelogenous leukemia, myelodysplastic syndromes, accelerated phase chronic myelogenous leukemia (CML), second chronic phase CML, and non-Hodgkin's lymphoma. The low-risk group includes Hodgkin's lymphoma, first chronic phase CML, multiple myeloma, and chronic lymphocytic leukemia.
Patients receive fludarabine IV on days -4 to -2. Patients undergo total-body irradiation on day 0 followed by allogeneic stem cell transplantation. Patients also receive oral mycophenolate mofetil on days 0-28.
High-risk patients receive oral cyclosporine twice daily on days -2 to day 60. Patients with persistent disease, T-cell chimerism, and no graft-vs-host disease (GVHD) on day 90 receive up to 3 doses of donor leukocyte infusion (DLI) over the next 4 months.
Low-risk patients receive oral cyclosporine twice daily on days -2 to day 150. Patients with persistent disease, T-cell chimerism, and no GVHD on day 180 receive up to 3 doses of DLI over the next 4 months.
Quality of life is assessed at baseline and at 1, 3, 6, 9, 12, 18, and 24 months.
Patients are followed at 1, 3, 6, 9, and 12 months and then annually for 2 years.
PROJECTED ACCRUAL: A total of 120 patients (60 per group) will be accrued for this study.
Ages Eligible for Study: | 18 Years to 75 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
DISEASE CHARACTERISTICS:
Diagnosis of one of the following hematologic malignancies:
Chronic myelogenous leukemia (CML)
Acute myelogenous leukemia (AML)
Myelodysplastic syndromes (MDS)
Hodgkin's lymphoma
Non-Hodgkin's lymphoma (NHL)
Chronic lymphocytic leukemia (CLL)
PATIENT CHARACTERISTICS:
Age
Performance status
Life expectancy
Hematopoietic
Hepatic
Renal
Cardiovascular
Pulmonary
Other
PRIOR CONCURRENT THERAPY:
Biologic therapy
Chemotherapy
Endocrine therapy
Radiotherapy
Surgery
United States, Colorado | |
Rocky Mountain Cancer Centers - Denver Midtown | |
Denver, Colorado, United States, 80218 | |
United States, Florida | |
Florida Hospital Cancer Institute | |
Orlando, Florida, United States, 32804 | |
United States, Georgia | |
Blood and Marrow Transplant Group of Georgia | |
Atlanta, Georgia, United States, 30342-4777 | |
United States, Iowa | |
Holden Comprehensive Cancer Center at University of Iowa | |
Iowa City, Iowa, United States, 52242-1009 | |
United States, Missouri | |
Kansas City Cancer Centers - Central | |
Kansas City, Missouri, United States, 64111 | |
United States, New Jersey | |
Cancer Center at Hackensack University Medical Center | |
Hackensack, New Jersey, United States, 07601 | |
St. Joseph's Hospital and Medical Center | |
Paterson, New Jersey, United States, 07503 | |
United States, New York | |
James P. Wilmot Cancer Center at University of Rochester Medical Center | |
Rochester, New York, United States, 14642 | |
United States, Oregon | |
Cancer Institute at Oregon Health and Science University | |
Portland, Oregon, United States, 97239-3098 | |
United States, Tennessee | |
Vanderbilt-Ingram Cancer Center at Vanderbilt Medical Center | |
Nashville, Tennessee, United States, 37212 | |
United States, Texas | |
Simmons Cancer Center at University of Texas Southwestern Medical Center - Dallas | |
Dallas, Texas, United States, 75235-8590 | |
Texas Transplant Institute | |
San Antonio, Texas, United States, 78229 | |
United States, Virginia | |
Massey Cancer Center at Virginia Commonwealth University | |
Richmond, Virginia, United States, 23298-0037 | |
United States, Wisconsin | |
University of Wisconsin Comprehensive Cancer Center | |
Madison, Wisconsin, United States, 53792 |
Study Chair: | Robert H. Collins, MD | Simmons Cancer Center |
Study ID Numbers: | CDR0000069461, UTSMC-0799296, AMGEN-UTSMC-0799296, IBMTR-SC-00-03.1, ROCHE-UTSMC-0799296, SPRI-UTSMC-0799296, NCI-V02-1705 |
Study First Received: | September 6, 2002 |
Last Updated: | November 16, 2008 |
ClinicalTrials.gov Identifier: | NCT00044954 |
Health Authority: | United States: Federal Government |
recurrent adult Hodgkin lymphoma stage I multiple myeloma stage II multiple myeloma stage III multiple myeloma chronic phase chronic myelogenous leukemia accelerated phase chronic myelogenous leukemia adult acute myeloid leukemia in remission recurrent grade 3 follicular lymphoma recurrent adult diffuse large cell lymphoma de novo myelodysplastic syndromes previously treated myelodysplastic syndromes secondary myelodysplastic syndromes recurrent mantle cell lymphoma stage III mantle cell lymphoma |
stage IV mantle cell lymphoma refractory multiple myeloma stage I mantle cell lymphoma contiguous stage II mantle cell lymphoma noncontiguous stage II mantle cell lymphoma atypical chronic myeloid leukemia myelodysplastic/myeloproliferative disease, unclassifiable refractory chronic lymphocytic leukemia 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 adult acute myeloid leukemia with t(15;17)(q22;q12) |
Cyclosporine Chronic myelogenous leukemia Miconazole Lymphoma, Mantle-Cell Hodgkin lymphoma, adult Cyclosporins Preleukemia Hemorrhagic Disorders Multiple myeloma Leukemia, Lymphocytic, Chronic, B-Cell Mycophenolate mofetil Neoplasm Metastasis Acute myeloid leukemia, adult Hodgkin Disease Myelodysplastic syndromes |
Chronic lymphocytic leukemia Lymphoma, Large B-Cell, Diffuse Immunoproliferative Disorders Hematologic Diseases Leukemia, Myeloid, Chronic, Atypical, BCR-ABL Negative Blood Coagulation Disorders Leukemia, B-cell, chronic Myeloproliferative Disorders Acute myelogenous leukemia Leukemia, Myeloid Multiple Myeloma Myelodysplastic myeloproliferative disease Leukemia, Myeloid, Accelerated Phase Fludarabine Leukemia, Lymphoid |
Antimetabolites Anti-Infective Agents Antimetabolites, Antineoplastic Neoplasms by Histologic Type Disease Immune System Diseases Molecular Mechanisms of Pharmacological Action Immunologic Factors Antineoplastic Agents Physiological Effects of Drugs Enzyme Inhibitors |
Immunosuppressive Agents Pharmacologic Actions Neoplasms Pathologic Processes Therapeutic Uses Antifungal Agents Syndrome Cardiovascular Diseases Antirheumatic Agents Dermatologic Agents |