Total-Body Irradiation, Fludarabine, and Peripheral Stem Cell Transplantation in Treating Patients With Hematologic Cancer
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|ClinicalTrials.gov Identifier: NCT00044954|
Recruitment Status : Completed
First Posted : January 27, 2003
Last Update Posted : September 17, 2019
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 or disease||Intervention/treatment||Phase|
|Leukemia Lymphoma Multiple Myeloma and Plasma Cell Neoplasm Myelodysplastic Syndromes Myelodysplastic/Myeloproliferative Diseases||Biological: therapeutic allogeneic lymphocytes Drug: cyclosporine Drug: fludarabine phosphate Drug: mycophenolate mofetil Procedure: allogeneic bone marrow transplantation Procedure: peripheral blood stem cell transplantation Radiation: radiation therapy||Phase 2|
- Determine the response rate and duration of response in patients with low-risk hematologic malignancies treated with low-dose total-body irradiation (TBI) and fludarabine followed by HLA-matched allogeneic stem cell transplantation followed by a slow immunosuppression taper and donor leukocyte infusions (DLI).
- Determine the response rate and duration of response in patients with high-risk hematologic malignancies treated with low-dose TBI and fludarabine followed by HLA-matched allogeneic stem cell transplantation followed by a faster immunosuppression taper and DLI.
- Determine the incidence and extent of graft-versus-host disease, regimen-related toxicity, and engraftment in patients treated with these regimens.
- Assess the quality of life of patients treated with these regimens.
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.
|Study Type :||Interventional (Clinical Trial)|
|Masking:||None (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|
|Actual Study Start Date :||November 1999|
|Actual Primary Completion Date :||November 2006|
|Actual Study Completion Date :||November 2006|
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00044954
|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|