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| ID | Type | Description | Link |
|---|---|---|---|
| UTSMC-0799296 | |||
| AMGEN-UTSMC-0799296 | |||
| IBMTR-SC-00-03.1 | |||
| ROCHE-UTSMC-0799296 | |||
| SPRI-UTSMC-0799296 | |||
| NCI-V02-1705 |
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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.
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.
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| therapeutic allogeneic lymphocytes | Biological | |||
| cyclosporine | Drug | |||
| fludarabine phosphate | Drug | |||
| mycophenolate mofetil | Drug | |||
| allogeneic bone marrow transplantation | Procedure | |||
| peripheral blood stem cell transplantation | Procedure | |||
| radiation therapy | Radiation |
DISEASE CHARACTERISTICS:
Diagnosis of one of the following hematologic malignancies:
Chronic myelogenous leukemia (CML)
Acute myelogenous leukemia (AML)
Myelodysplastic syndromes (MDS)
Multiple myeloma (MM)
Hodgkin's lymphoma
Non-Hodgkin's lymphoma (NHL)
Chronic lymphocytic leukemia (CLL)
Must have 6 out of 6 HLA A-, B-, and DR- identical sibling donor
PATIENT CHARACTERISTICS:
Age
Performance status
Life expectancy
Hematopoietic
Hepatic
Renal
Cardiovascular
Pulmonary
Other
PRIOR CONCURRENT THERAPY:
Biologic therapy
Chemotherapy
Endocrine therapy
Radiotherapy
Surgery
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| Name | Affiliation | Role |
|---|---|---|
| Robert H. Collins, MD | Simmons Cancer Center | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Rocky Mountain Cancer Centers - Denver Midtown | Denver | Colorado | 80218 | United States | ||
| Florida Hospital Cancer Institute |
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| Orlando |
| Florida |
| 32804 |
| United States |
| Blood and Marrow Transplant Group of Georgia | Atlanta | Georgia | 30342-4777 | United States |
| Holden Comprehensive Cancer Center at University of Iowa | Iowa City | Iowa | 52242-1009 | United States |
| Kansas City Cancer Centers - Central | Kansas City | Missouri | 64111 | United States |
| Cancer Center at Hackensack University Medical Center | Hackensack | New Jersey | 07601 | United States |
| St. Joseph's Hospital and Medical Center | Paterson | New Jersey | 07503 | United States |
| James P. Wilmot Cancer Center at University of Rochester Medical Center | Rochester | New York | 14642 | United States |
| Cancer Institute at Oregon Health and Science University | Portland | Oregon | 97239-3098 | United States |
| Vanderbilt-Ingram Cancer Center at Vanderbilt Medical Center | Nashville | Tennessee | 37212 | United States |
| Simmons Cancer Center at University of Texas Southwestern Medical Center - Dallas | Dallas | Texas | 75235-8590 | United States |
| Texas Transplant Institute | San Antonio | Texas | 78229 | United States |
| Massey Cancer Center at Virginia Commonwealth University | Richmond | Virginia | 23298-0037 | United States |
| University of Wisconsin Comprehensive Cancer Center | Madison | Wisconsin | 53792 | United States |
| ID | Term |
|---|---|
| D007938 | Leukemia |
| D008223 | Lymphoma |
| D009101 | Multiple Myeloma |
| D054219 | Neoplasms, Plasma Cell |
| D009190 | Myelodysplastic Syndromes |
| D054437 | Myelodysplastic-Myeloproliferative Diseases |
| D006689 | Hodgkin Disease |
| D015466 | Leukemia, Myeloid, Chronic-Phase |
| D015465 | Leukemia, Myeloid, Accelerated Phase |
| D008224 | Lymphoma, Follicular |
| D016403 | Lymphoma, Large B-Cell, Diffuse |
| D020522 | Lymphoma, Mantle-Cell |
| D054438 | Leukemia, Myeloid, Chronic, Atypical, BCR-ABL Negative |
| D009196 | Myeloproliferative Disorders |
| D015451 | Leukemia, Lymphocytic, Chronic, B-Cell |
| D000013 | Congenital Abnormalities |
| ID | Term |
|---|---|
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
| D006402 | Hematologic Diseases |
| D006425 | Hemic and Lymphatic Diseases |
| D008232 | Lymphoproliferative Disorders |
| D008206 | Lymphatic Diseases |
| D007160 | Immunoproliferative Disorders |
| D007154 | Immune System Diseases |
| D020141 | Hemostatic Disorders |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
| D010265 | Paraproteinemias |
| D001796 | Blood Protein Disorders |
| D006474 | Hemorrhagic Disorders |
| D001855 | Bone Marrow Diseases |
| D015464 | Leukemia, Myelogenous, Chronic, BCR-ABL Positive |
| D007951 | Leukemia, Myeloid |
| D002908 | Chronic Disease |
| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D008228 | Lymphoma, Non-Hodgkin |
| D016393 | Lymphoma, B-Cell |
| D015448 | Leukemia, B-Cell |
| D007945 | Leukemia, Lymphoid |
| D009358 | Congenital, Hereditary, and Neonatal Diseases and Abnormalities |
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| ID | Term |
|---|---|
| D016572 | Cyclosporine |
| C042382 | fludarabine phosphate |
| D009173 | Mycophenolic Acid |
| D036102 | Peripheral Blood Stem Cell Transplantation |
| D011878 | Radiotherapy |
| ID | Term |
|---|---|
| D003524 | Cyclosporins |
| D010456 | Peptides, Cyclic |
| D047028 | Macrocyclic Compounds |
| D011083 | Polycyclic Compounds |
| D010455 | Peptides |
| D000602 | Amino Acids, Peptides, and Proteins |
| D002208 | Caproates |
| D000144 | Acids, Acyclic |
| D002264 | Carboxylic Acids |
| D009930 | Organic Chemicals |
| D005227 | Fatty Acids |
| D008055 | Lipids |
| D018380 | Hematopoietic Stem Cell Transplantation |
| D033581 | Stem Cell Transplantation |
| D017690 | Cell Transplantation |
| D064987 | Cell- and Tissue-Based Therapy |
| D001691 | Biological Therapy |
| D013812 | Therapeutics |
| D014180 | Transplantation |
| D013514 | Surgical Procedures, Operative |
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