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| ID | Type | Description | Link |
|---|---|---|---|
| ECOG-E1499 |
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RATIONALE: Monoclonal antibodies, such as rituximab and yttrium Y 90 ibritumomab tiuxetan, can locate cancer cells and either kill them or deliver radioactive cancer-killing substances to them without harming normal cells. Drugs used in chemotherapy, such as prednisone, cyclophosphamide, doxorubicin, and vincristine, use different ways to stop cancer cells from dividing so they stop growing or die. Combining monoclonal antibody therapy with chemotherapy may kill more cancer cells.
PURPOSE: This phase II trial is studying how well giving rituximab and combination chemotherapy together with yttrium Y 90 ibritumomab tiuxetan works in treating patients with previously untreated mantle cell lymphoma.
OBJECTIVES:
OUTLINE: This is a multicenter study.
Patients who have responding or stable disease proceed to radioimmunotherapy.
Patients are followed every 3 months for 2 years, every 6 months for 3 years, and then annually for 5 years.
PROJECTED ACCRUAL: A total of 57 patients will be accrued for this study within 2.8 years.
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| rituximab | Biological | |||
| cyclophosphamide | Drug | |||
| doxorubicin hydrochloride | Drug | |||
| prednisone | Drug | |||
| vincristine sulfate | Drug | |||
| yttrium Y 90 ibritumomab tiuxetan | Radiation |
DISEASE CHARACTERISTICS:
Histologically confirmed mantle cell lymphoma with expression of bcl-1 and CD20
Measurable or evaluable disease
No known CNS lymphoma
PATIENT CHARACTERISTICS:
Age
Performance status
Life expectancy
Hematopoietic
Hepatic
Renal
Cardiovascular
Other
PRIOR CONCURRENT THERAPY:
Biologic therapy
Chemotherapy
Endocrine therapy
Radiotherapy
Surgery
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| Name | Affiliation | Role |
|---|---|---|
| Mitchell R. Smith, MD, PhD | Fox Chase Cancer Center | Study Chair |
| Leo I. Gordon, MD | Robert H. Lurie Cancer Center |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Comprehensive Cancer Center at University of Alabama at Birmingham | Birmingham | Alabama | 35294-3300 | United States | ||
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| Result | Smith MR, Zhang L, Gordon LI, et al.: Phase II study of R-CHOP followed by 90Y-ibritumomab tiuxetan in untreated mantle cell lymphoma: Eastern Cooperative Oncology Group study E1499. [Abstract] Blood 110 (11): A-389, 2007. | ||
| Result | Smith MR, Chen H, Gordon L, et al.: Phase II study of rituximab + CHOP followed by 90Y-ibritumomab tiuxetan in patients with previously untreated mantle cell lymphoma: an Eastern Cooperative Oncology Group Study (E1499). [Abstract] J Clin Oncol 24 (Suppl 18): A-7503, 422s, 2006. |
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| CCOP - Mayo Clinic Scottsdale Oncology Program |
| Scottsdale |
| Arizona |
| 85259-5404 |
| United States |
| City of Hope Comprehensive Cancer Center | Duarte | California | 91010-3000 | United States |
| Veterans Affairs Medical Center - Palo Alto | Palo Alto | California | 94304-1290 | United States |
| Stanford Cancer Center at Stanford University Medical Center | Stanford | California | 94305-5216 | United States |
| CCOP - Colorado Cancer Research Program, Incorporated | Denver | Colorado | 80224 | United States |
| CCOP - Christiana Care Health Services | Newark | Delaware | 19713 | United States |
| MBCCOP - Howard University Cancer Center | Washington D.C. | District of Columbia | 20060 | United States |
| Veterans Affairs Medical Center - Gainesville | Gainesville | Florida | 32608-1197 | United States |
| Veterans Affairs Medical Center - Miami | Miami | Florida | 33125 | United States |
| H. Lee Moffitt Cancer Center and Research Institute at University of South Florida | Tampa | Florida | 33612-9497 | United States |
| Veterans Affairs Medical Center - Tampa (Haley) | Tampa | Florida | 33612 | United States |
| Winship Cancer Institute of Emory University | Atlanta | Georgia | 30322 | United States |
| Veterans Affairs Medical Center - Atlanta (Decatur) | Decatur | Georgia | 30033 | United States |
| Veterans Affairs Medical Center - Lakeside Chicago | Chicago | Illinois | 60611-4494 | United States |
| Robert H. Lurie Comprehensive Cancer Center at Northwestern University | Chicago | Illinois | 60611 | United States |
| CCOP - Central Illinois | Decatur | Illinois | 62526 | United States |
| CCOP - Evanston | Evanston | Illinois | 60201 | United States |
| CCOP - Illinois Oncology Research Association | Peoria | Illinois | 61615-7828 | United States |
| Swedish-American Regional Cancer Center | Rockford | Illinois | 61104-2315 | United States |
| CCOP - Carle Cancer Center | Urbana | Illinois | 61801 | United States |
| Indiana University Cancer Center | Indianapolis | Indiana | 46202-5289 | United States |
| Veterans Affairs Medical Center - Indianapolis (Roudebush) | Indianapolis | Indiana | 46202 | United States |
| CCOP - Northern Indiana CR Consortium | South Bend | Indiana | 46601 | United States |
| CCOP - Cedar Rapids Oncology Project | Cedar Rapids | Iowa | 52403-1206 | United States |
| CCOP - Iowa Oncology Research Association | Des Moines | Iowa | 50309-1016 | United States |
| John Stoddard Cancer Center at Iowa Methodist Medical Center | Des Moines | Iowa | 50309 | United States |
| Mercy Cancer Center at Mercy Medical Center - Des Moines | Des Moines | Iowa | 50314 | United States |
| John Stoddard Cancer Center at Iowa Lutheran Hospital | Des Moines | Iowa | 50316-2301 | United States |
| Burgess Health Center | Onawa | Iowa | 51040 | United States |
| CCOP - Wichita | Wichita | Kansas | 67214-3882 | United States |
| Veterans Affairs Medical Center - Wichita | Wichita | Kansas | 67218 | United States |
| MBCCOP - LSU Health Sciences Center | New Orleans | Louisiana | 70112 | United States |
| CCOP - Ochsner | New Orleans | Louisiana | 70121 | United States |
| Cancer Center at Tufts - New England Medical Center | Boston | Massachusetts | 02111 | United States |
| Beth Israel Deaconess Medical Center | Boston | Massachusetts | 02215 | United States |
| CCOP - Michigan Cancer Research Consortium | Ann Arbor | Michigan | 48106 | United States |
| CCOP - Kalamazoo | Kalamazoo | Michigan | 49007-3731 | United States |
| CCOP - Duluth | Duluth | Minnesota | 55805 | United States |
| Veterans Affairs Medical Center - Minneapolis | Minneapolis | Minnesota | 55417-2399 | United States |
| University of Minnesota Cancer Center | Minneapolis | Minnesota | 55455 | United States |
| Mayo Clinic Cancer Center | Rochester | Minnesota | 55905 | United States |
| CCOP - Metro-Minnesota | Saint Louis Park | Minnesota | 55416 | United States |
| Veterans Affairs Medical Center - Omaha | Omaha | Nebraska | 68105 | United States |
| CCOP - Missouri Valley Cancer Consortium | Omaha | Nebraska | 68106 | United States |
| Midlands Cancer Center at Midlands Community Hospital | Papillion | Nebraska | 68128-4157 | United States |
| CCOP - Southern Nevada Cancer Research Foundation | Las Vegas | Nevada | 89106 | United States |
| Norris Cotton Cancer Center at Dartmouth-Hitchcock Medical Center | Lebanon | New Hampshire | 03756-0002 | United States |
| Veterans Affairs Medical Center - East Orange | East Orange | New Jersey | 07018 | United States |
| CCOP - Northern New Jersey | Hackensack | New Jersey | 07601 | United States |
| Cancer Institute of New Jersey at UMDNJ - Robert Wood Johnson Medical School | New Brunswick | New Jersey | 08903 | United States |
| MBCCOP - University of New Mexico HSC | Albuquerque | New Mexico | 87131 | United States |
| Veterans Affairs Medical Center - Brooklyn | Brooklyn | New York | 11209 | United States |
| Veterans Affairs Medical Center - New York | New York | New York | 10010 | United States |
| NYU Cancer Institute at New York University Medical Center | New York | New York | 10016 | United States |
| Albert Einstein Cancer Center at Albert Einstein College of Medicine | The Bronx | New York | 10461 | United States |
| MBCCOP-Our Lady of Mercy Cancer Center | The Bronx | New York | 10466 | United States |
| CCOP - Merit Care Hospital | Fargo | North Dakota | 58122 | United States |
| MetroHealth's Cancer Care Center at MetroHealth Medical Center | Cleveland | Ohio | 44109 | United States |
| Cleveland Clinic Taussig Cancer Center | Cleveland | Ohio | 44195 | United States |
| CCOP - Columbus | Columbus | Ohio | 43206 | United States |
| CCOP - Toledo Community Hospital | Toledo | Ohio | 43623-3456 | United States |
| CCOP - Oklahoma | Tulsa | Oklahoma | 74136 | United States |
| CCOP - Geisinger Clinic and Medical Center | Danville | Pennsylvania | 17822-2001 | United States |
| Penn State Cancer Institute at Milton S. Hershey Medical Center | Hershey | Pennsylvania | 17033-0850 | United States |
| Hahnemann University Hospital | Philadelphia | Pennsylvania | 19102-1192 | United States |
| Abramson Cancer Center of the University of Pennsylvania | Philadelphia | Pennsylvania | 19104 | United States |
| Fox Chase Cancer Center | Philadelphia | Pennsylvania | 19111-2497 | United States |
| Hillman Cancer Center at University of Pittsburgh Cancer Institute | Pittsburgh | Pennsylvania | 15236 | United States |
| Veterans Affairs Medical Center - Pittsburgh | Pittsburgh | Pennsylvania | 15240 | United States |
| CCOP - MainLine Health | Wynnewood | Pennsylvania | 19096 | United States |
| CCOP - Sioux Community Cancer Consortium | Sioux Falls | South Dakota | 57104 | United States |
| Veterans Affairs Medical Center - Tennessee Valley Healthcare System - Nashville Campus | Nashville | Tennessee | 37212-2637 | United States |
| Vanderbilt-Ingram Cancer Center at Vanderbilt Medical Center | Nashville | Tennessee | 37232-6307 | United States |
| CCOP - Scott and White Hospital | Temple | Texas | 76508 | United States |
| CCOP - St. Vincent Hospital Cancer Center, Green Bay | Green Bay | Wisconsin | 54301 | United States |
| Veterans Affairs Medical Center - Madison | Madison | Wisconsin | 53705 | United States |
| University of Wisconsin Comprehensive Cancer Center | Madison | Wisconsin | 53792-0001 | United States |
| CCOP - Marshfield Clinic Research Foundation | Marshfield | Wisconsin | 54449 | United States |
| Medical College of Wisconsin Cancer Center | Milwaukee | Wisconsin | 53226-3596 | United States |
| Veterans Affairs Medical Center - Milwaukee (Zablocki) | Milwaukee | Wisconsin | 53295 | United States |
| Westmead Hospital | Westmead | New South Wales | 2145 | Australia |
| Instituto de Enfermedades Neoplasicas | Lima | 34 | Peru |
| MBCCOP - San Juan | San Juan | 00921-3201 | Puerto Rico |
| Veterans Affairs Medical Center - San Juan | San Juan | 00927-5800 | Puerto Rico |
| San Juan City Hospital | San Juan | 00936-7344 | Puerto Rico |
| Pretoria Academic Hospital | Pretoria | 0001 | South Africa |
| ID | Term |
|---|---|
| D008223 | Lymphoma |
| D020522 | Lymphoma, Mantle-Cell |
| ID | Term |
|---|---|
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
| D008232 | Lymphoproliferative Disorders |
| D008206 | Lymphatic Diseases |
| D006425 | Hemic and Lymphatic Diseases |
| D007160 | Immunoproliferative Disorders |
| D007154 | Immune System Diseases |
| D008228 | Lymphoma, Non-Hodgkin |
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| ID | Term |
|---|---|
| D000069283 | Rituximab |
| D003520 | Cyclophosphamide |
| D004317 | Doxorubicin |
| D011241 | Prednisone |
| D014750 | Vincristine |
| C422802 | ibritumomab tiuxetan |
| ID | Term |
|---|---|
| D058846 | Antibodies, Monoclonal, Murine-Derived |
| D000911 | Antibodies, Monoclonal |
| D000906 | Antibodies |
| D007136 | Immunoglobulins |
| D007162 | Immunoproteins |
| D001798 | Blood Proteins |
| D011506 | Proteins |
| D000602 | Amino Acids, Peptides, and Proteins |
| D012712 | Serum Globulins |
| D005916 | Globulins |
| D010752 | Phosphoramide Mustards |
| D009588 | Nitrogen Mustard Compounds |
| D009150 | Mustard Compounds |
| D006846 | Hydrocarbons, Halogenated |
| D006838 | Hydrocarbons |
| D009930 | Organic Chemicals |
| D063088 | Phosphoramides |
| D009943 | Organophosphorus Compounds |
| D003630 | Daunorubicin |
| D018943 | Anthracyclines |
| D009279 | Naphthacenes |
| D011084 | Polycyclic Aromatic Hydrocarbons |
| D006841 | Hydrocarbons, Aromatic |
| D006844 | Hydrocarbons, Cyclic |
| D011083 | Polycyclic Compounds |
| D000617 | Aminoglycosides |
| D006027 | Glycosides |
| D002241 | Carbohydrates |
| D011244 | Pregnadienediols |
| D011245 | Pregnadienes |
| D011278 | Pregnanes |
| D013256 | Steroids |
| D000072473 | Fused-Ring Compounds |
| D014748 | Vinca Alkaloids |
| D046948 | Secologanin Tryptamine Alkaloids |
| D026121 | Indole Alkaloids |
| D000470 | Alkaloids |
| D006571 | Heterocyclic Compounds |
| D007211 | Indoles |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D054836 | Indolizidines |
| D007212 | Indolizines |
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