CCI-779 and Rituximab in Treating Patients With Relapsed or Refractory Non-Hodgkin's Lymphoma
21. marts 2014 opdateret af: National Cancer Institute (NCI)
A Phase II Study of CCI-779 in Combination With Rituximab in Patients With Relapsed or Refractory Mantle Cell Lymphoma
This phase II trial is studying how well giving CCI-779 together with rituximab works in treating patients with relapsed or refractory mantle cell lymphoma.
Drugs used in chemotherapy, such as CCI-779, work in different ways to stop the growth of cancer cells, either by killing the cells or by stopping them from dividing.
Monoclonal antibodies, such as rituximab, can block cancer growth in different ways.
Some block the ability of cancer cells to grow and spread.
Others find cancer cells and help kill them or carry cancer-killing substances to them.
Giving CCI-779 together with rituximab may kill more cancer cells
Studieoversigt
Status
Afsluttet
Betingelser
Intervention / Behandling
Detaljeret beskrivelse
PRIMARY OBJECTIVES:
I. Determine the overall response rate in patients with relapsed or refractory mantle cell lymphoma treated with CCI-779 and rituximab.
II. Determine the tolerability of this regimen in these patients by assessing toxicity.
SECONDARY OBJECTIVES:
I. Determine the time to disease progression and overall survival of patients treated with this regimen.
II. Determine the duration of response in patients treated with this regimen.
OUTLINE: Patients are stratified according to prior response to rituximab (sensitive [partial response (PR) or complete response (CR) that lasted ≥ 6 months after the last treatment with rituximab alone or in combination with chemotherapy] vs refractory [stable or progressive disease OR a PR or CR that lasted < 6 months after the last treatment with rituximab alone or in combination with chemotherapy]).
Patients receive CCI-779 IV over 30 minutes on days 1, 8, 15, and 22. Patients also receive rituximab IV on days 1, 8, 15, and 22 of course 1 and on day 1 only of courses 3, 5, 7, 9, and 11. Treatment repeats every 28 days for up to 12 courses in the absence of disease progression or unacceptable toxicity. After completion of course 3, patients undergo reevaluation. Patients achieving a CR or an unconfirmed CR (CRu) receive 2 additional courses of treatment for a total of 5 courses. Patients achieving a PR or stable disease continue study treatment as outlined above for up to 12 courses. Patients achieving a PR or stable disease who subsequently achieve a CR or CRu between courses 3 and 10 receive 2 additional courses of treatment.
After completion of study treatment, patients are followed every 3 months for 1 year, every 4 months for 1 year, every 6 months for 1 year, and then annually for 2 years.
Undersøgelsestype
Interventionel
Tilmelding (Faktiske)
71
Fase
- Fase 2
Kontakter og lokationer
Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.
Studiesteder
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Alabama
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Mobile, Alabama, Forenede Stater, 36607
- Mobile Infirmary Medical Center
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Colorado
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Aurora, Colorado, Forenede Stater, 80012
- The Medical Center of Aurora
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Boulder, Colorado, Forenede Stater, 80301
- Boulder Community Hospital
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Colorado Springs, Colorado, Forenede Stater, 80907
- Penrose-Saint Francis Healthcare
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Denver, Colorado, Forenede Stater, 80210
- Porter Adventist Hospital
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Denver, Colorado, Forenede Stater, 80218
- Presbyterian - Saint Lukes Medical Center - Health One
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Denver, Colorado, Forenede Stater, 80220
- Rose Medical Center
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Denver, Colorado, Forenede Stater, 80218
- Exempla Saint Joseph Hospital
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Denver, Colorado, Forenede Stater, 80224-2522
- Colorado Cancer Research Program CCOP
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Denver, Colorado, Forenede Stater, 80204
- Saint Anthony Central Hospital
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Englewood, Colorado, Forenede Stater, 80110
- Swedish Medical Center
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Grand Junction, Colorado, Forenede Stater, 81502
- Saint Mary's Hospital and Regional Medical Center
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Greeley, Colorado, Forenede Stater, 80631
- North Colorado Medical Center
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Lone Tree, Colorado, Forenede Stater, 80124
- Sky Ridge Medical Center
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Longmont, Colorado, Forenede Stater, 80501
- Longmont United Hospital
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Loveland, Colorado, Forenede Stater, 80539
- McKee Medical Center
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Pueblo, Colorado, Forenede Stater, 81004
- Saint Mary Corwin Medical Center
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Thornton, Colorado, Forenede Stater, 80229
- North Suburban Medical Center
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Wheat Ridge, Colorado, Forenede Stater, 80033
- Exempla Lutheran Medical Center
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Illinois
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Aurora, Illinois, Forenede Stater, 60504
- Rush - Copley Medical Center
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Bloomington, Illinois, Forenede Stater, 61701
- Saint Joseph Medical Center
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Canton, Illinois, Forenede Stater, 61520
- Graham Hospital Association
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Carthage, Illinois, Forenede Stater, 62321
- Memorial Hospital
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Eureka, Illinois, Forenede Stater, 61530
- Eureka Hospital
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Galesburg, Illinois, Forenede Stater, 61401
- Galesburg Cottage Hospital
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Galesburg, Illinois, Forenede Stater, 61401
- Galesburg Clinic
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Havana, Illinois, Forenede Stater, 62644
- Mason District Hospital
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Hopedale, Illinois, Forenede Stater, 61747
- Hopedale Medical Complex - Hospital
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Joliet, Illinois, Forenede Stater, 60435
- Joliet Oncology-Hematology Associates Limited
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Kewanee, Illinois, Forenede Stater, 61443
- Kewanee Hospital
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Macomb, Illinois, Forenede Stater, 61455
- Mcdonough District Hospital
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Normal, Illinois, Forenede Stater, 61761
- Community Cancer Center Foundation
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Normal, Illinois, Forenede Stater, 61761
- Bromenn Regional Medical Center
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Ottawa, Illinois, Forenede Stater, 61350
- Illinois CancerCare-Ottawa Clinic
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Ottawa, Illinois, Forenede Stater, 61350
- Ottawa Regional Hospital and Healthcare Center
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Pekin, Illinois, Forenede Stater, 61554
- Pekin Cancer Treatment Center
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Pekin, Illinois, Forenede Stater, 61554
- Pekin Hospital
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Peoria, Illinois, Forenede Stater, 61637
- OSF Saint Francis Medical Center
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Peoria, Illinois, Forenede Stater, 61615
- Illinois CancerCare-Peoria
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Peoria, Illinois, Forenede Stater, 61614
- Proctor Hospital
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Peoria, Illinois, Forenede Stater, 61603
- Methodist Medical Center of Illinois
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Peoria, Illinois, Forenede Stater, 61615
- Illinois Oncology Research Association CCOP
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Peru, Illinois, Forenede Stater, 61354
- Illinois Valley Hospital
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Princeton, Illinois, Forenede Stater, 61356
- Perry Memorial Hospital
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Spring Valley, Illinois, Forenede Stater, 61362
- Saint Margaret's Hospital
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Urbana, Illinois, Forenede Stater, 61801
- Carle Clinic-Urbana Main
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Urbana, Illinois, Forenede Stater, 61801
- Carle Foundation dba Carle Cancer Center
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Indiana
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Beech Grove, Indiana, Forenede Stater, 46107
- Saint Francis Hospital and Health Centers
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Michigan City, Indiana, Forenede Stater, 46360
- Saint Anthony Memorial Health Center
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Richmond, Indiana, Forenede Stater, 47374
- Reid Hospital and Health Care Services
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Iowa
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Ames, Iowa, Forenede Stater, 50010
- McFarland Clinic
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Cedar Rapids, Iowa, Forenede Stater, 52403
- Mercy Hospital
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Cedar Rapids, Iowa, Forenede Stater, 52402
- Saint Luke's Hospital
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Cedar Rapids, Iowa, Forenede Stater, 52403
- Cedar Rapids Oncology Association
-
Cedar Rapids, Iowa, Forenede Stater, 52403
- Oncology Associates
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Clive, Iowa, Forenede Stater, 50325
- Medical Oncology and Hematology Associates-West Des Moines
-
Des Moines, Iowa, Forenede Stater, 50309
- Iowa Methodist Medical Center
-
Des Moines, Iowa, Forenede Stater, 50314
- Mercy Medical Center - Des Moines
-
Des Moines, Iowa, Forenede Stater, 50309
- Medical Oncology and Hematology Associates-Des Moines
-
Des Moines, Iowa, Forenede Stater, 50316
- Iowa Lutheran Hospital
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Des Moines, Iowa, Forenede Stater, 50307
- Mercy Capitol
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Des Moines, Iowa, Forenede Stater, 50309
- Iowa Oncology Research Association CCOP
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Des Moines, Iowa, Forenede Stater, 50314
- Medical Oncology and Hematology Associates
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Mason City, Iowa, Forenede Stater, 50401
- Mercy Medical Center - North Iowa
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Sioux City, Iowa, Forenede Stater, 51104
- Saint Luke's Regional Medical Center
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Sioux City, Iowa, Forenede Stater, 51101-1733
- Siouxland Regional Cancer Center
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Sioux City, Iowa, Forenede Stater, 51104
- Mercy Medical Center-Sioux City
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Sioux City, Iowa, Forenede Stater, 51101
- Siouxland Hematology - Oncology Associates
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Kansas
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Anthony, Kansas, Forenede Stater, 67003
- Hospital District Sixth of Harper County
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Chanute, Kansas, Forenede Stater, 66720
- Cancer Center of Kansas - Chanute
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Dodge City, Kansas, Forenede Stater, 67801
- Cancer Center of Kansas - Dodge City
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El Dorado, Kansas, Forenede Stater, 67042
- Cancer Center of Kansas - El Dorado
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Fort Scott, Kansas, Forenede Stater, 66701
- Cancer Center of Kansas - Fort Scott
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Independence, Kansas, Forenede Stater, 67301
- Cancer Center of Kansas-Independence
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Kingman, Kansas, Forenede Stater, 67068
- Cancer Center of Kansas-Kingman
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Lawrence, Kansas, Forenede Stater, 66044
- Lawrence Memorial Hospital
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Newton, Kansas, Forenede Stater, 67114
- Cancer Center of Kansas - Newton
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Parsons, Kansas, Forenede Stater, 67357
- Cancer Center of Kansas - Parsons
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Pratt, Kansas, Forenede Stater, 67124
- Cancer Center of Kansas - Pratt
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Salina, Kansas, Forenede Stater, 67401
- Cancer Center of Kansas - Salina
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Wellington, Kansas, Forenede Stater, 67152
- Cancer Center of Kansas - Wellington
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Wichita, Kansas, Forenede Stater, 67208
- Cancer Center of Kansas-Wichita Medical Arts Tower
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Wichita, Kansas, Forenede Stater, 67208
- Associates In Womens Health
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Wichita, Kansas, Forenede Stater, 67214
- Cancer Center of Kansas - Main Office
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Wichita, Kansas, Forenede Stater, 67214
- Via Christi Regional Medical Center
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Wichita, Kansas, Forenede Stater, 67214
- Wichita CCOP
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Winfield, Kansas, Forenede Stater, 67156
- Cancer Center of Kansas - Winfield
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Michigan
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Adrian, Michigan, Forenede Stater, 49221
- Bixby Medical Center
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Adrian, Michigan, Forenede Stater, 49221
- Hickman Cancer Center
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Ann Arbor, Michigan, Forenede Stater, 48106-0995
- Saint Joseph Mercy Hospital
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Ann Arbor, Michigan, Forenede Stater, 48106
- Michigan Cancer Research Consortium Community Clinical Oncology Program
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Dearborn, Michigan, Forenede Stater, 48123
- Oakwood Hospital
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Detroit, Michigan, Forenede Stater, 48236
- Saint John Hospital and Medical Center
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Flint, Michigan, Forenede Stater, 48502
- Hurley Medical Center
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Flint, Michigan, Forenede Stater, 48532
- Genesys Regional Medical Center
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Jackson, Michigan, Forenede Stater, 49201
- Allegiance Health
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Lansing, Michigan, Forenede Stater, 48912
- Sparrow Hospital
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Livonia, Michigan, Forenede Stater, 48154
- Saint Mary Mercy Hospital
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Monroe, Michigan, Forenede Stater, 48162
- Mercy Memorial Hospital
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Monroe, Michigan, Forenede Stater, 48162
- Community Cancer Center of Monroe
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Pontiac, Michigan, Forenede Stater, 48341-2985
- Saint Joseph Mercy Oakland
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Port Huron, Michigan, Forenede Stater, 48060
- Saint Joseph Mercy Port Huron
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Saginaw, Michigan, Forenede Stater, 48601
- Saint Mary's of Michigan
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Warren, Michigan, Forenede Stater, 48093
- Saint John Macomb-Oakland Hospital
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Minnesota
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Bemidji, Minnesota, Forenede Stater, 56601
- Merit Care Clinic Bemidji
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Burnsville, Minnesota, Forenede Stater, 55337
- Fairview Ridges Hospital
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Coon Rapids, Minnesota, Forenede Stater, 55433
- Mercy Hospital
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Duluth, Minnesota, Forenede Stater, 55805
- Miller-Dwan Hospital
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Duluth, Minnesota, Forenede Stater, 55805
- Saint Mary's Medical Center
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Duluth, Minnesota, Forenede Stater, 55805
- Duluth Clinic CCOP
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Edina, Minnesota, Forenede Stater, 55435
- Fairview-Southdale Hospital
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Fridley, Minnesota, Forenede Stater, 55432
- Unity Hospital
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Maplewood, Minnesota, Forenede Stater, 55109
- Minnesota Oncology Hematology PA-Maplewood
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Minneapolis, Minnesota, Forenede Stater, 55407
- Abbott-Northwestern Hospital
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Robbinsdale, Minnesota, Forenede Stater, 55422
- North Memorial Medical Health Center
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Rochester, Minnesota, Forenede Stater, 55905
- Mayo Clinic
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Saint Louis Park, Minnesota, Forenede Stater, 55416
- Park Nicollet Clinic - Saint Louis Park
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Saint Louis Park, Minnesota, Forenede Stater, 55416
- Metro-Minnesota CCOP
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Saint Paul, Minnesota, Forenede Stater, 55102
- United Hospital
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Shakopee, Minnesota, Forenede Stater, 55379
- Saint Francis Regional Medical Center
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Waconia, Minnesota, Forenede Stater, 55387
- Ridgeview Medical Center
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Woodbury, Minnesota, Forenede Stater, 55125
- Minnesota Oncology and Hematology PA-Woodbury
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Montana
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Billings, Montana, Forenede Stater, 59101
- Saint Vincent Healthcare
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Billings, Montana, Forenede Stater, 59101
- Northern Rockies Radiation Oncology Center
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Billings, Montana, Forenede Stater, 59101
- Montana Cancer Consortium CCOP
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Billings, Montana, Forenede Stater, 59107-7000
- Billings Clinic
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Billings, Montana, Forenede Stater, 59107
- Deaconess Medical Center
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Billings, Montana, Forenede Stater, 59101
- Hematology-Oncology Centers of the Northern Rockies PC
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Bozeman, Montana, Forenede Stater, 59715
- Bozeman Deaconess Hospital
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Bozeman, Montana, Forenede Stater, 59715
- Bozeman Deaconess Cancer Center
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Butte, Montana, Forenede Stater, 59701
- Saint James Community Hospital and Cancer Treatment Center
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Great Falls, Montana, Forenede Stater, 59405
- Great Falls Clinic
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Great Falls, Montana, Forenede Stater, 59405
- Berdeaux, Donald MD (UIA Investigator)
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Havre, Montana, Forenede Stater, 59501
- Northern Montana Hospital
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Helena, Montana, Forenede Stater, 59601
- Saint Peter's Community Hospital
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Kalispell, Montana, Forenede Stater, 59901
- Kalispell Regional Medical Center
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Kalispell, Montana, Forenede Stater, 59901
- Glacier Oncology PLLC
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Kalispell, Montana, Forenede Stater, 59901
- Kalispell Medical Oncology
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Missoula, Montana, Forenede Stater, 59802
- Saint Patrick Hospital - Community Hospital
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Missoula, Montana, Forenede Stater, 59804
- Guardian Oncology and Center for Wellness
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Missoula, Montana, Forenede Stater, 59801
- Community Medical Hospital
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Missoula, Montana, Forenede Stater, 59802
- Montana Cancer Specialists
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North Carolina
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Rutherfordton, North Carolina, Forenede Stater, 28139
- Rutherford Hospital
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North Dakota
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Bismarck, North Dakota, Forenede Stater, 58501
- Bismarck Cancer Center
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Bismarck, North Dakota, Forenede Stater, 58501
- Mid Dakota Clinic
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Bismarck, North Dakota, Forenede Stater, 58501
- Saint Alexius Medical Center
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Bismarck, North Dakota, Forenede Stater, 58501
- Medcenter One Health Systems
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Fargo, North Dakota, Forenede Stater, 58122
- MeritCare Medical Group
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Fargo, North Dakota, Forenede Stater, 58122
- Meritcare Hospital
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Ohio
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Bowling Green, Ohio, Forenede Stater, 43402
- Wood County Oncology Center
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Dayton, Ohio, Forenede Stater, 45406
- Good Samaritan Hospital - Dayton
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Dayton, Ohio, Forenede Stater, 45409
- Miami Valley Hospital
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Dayton, Ohio, Forenede Stater, 45415
- Samaritan North Health Center
-
Dayton, Ohio, Forenede Stater, 45405
- Grandview Hospital
-
Dayton, Ohio, Forenede Stater, 45428
- Veteran Affairs Medical Center
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Dayton, Ohio, Forenede Stater, 45429
- Dayton CCOP
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Elyria, Ohio, Forenede Stater, 44035
- Hematology Oncology Center Incorporated
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Findlay, Ohio, Forenede Stater, 45840
- Blanchard Valley Hospital
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Franklin, Ohio, Forenede Stater, 45005-1066
- Atrium Medical Center-Middletown Regional Hospital
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Fremont, Ohio, Forenede Stater, 43420
- Fremont Memorial Hospital
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Greenville, Ohio, Forenede Stater, 45331
- Wayne Hospital
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Kenton, Ohio, Forenede Stater, 43326
- Cole, Sharon, K. M.D. (UIA Investigator)
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Kettering, Ohio, Forenede Stater, 45429
- Kettering Medical Center
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Lima, Ohio, Forenede Stater, 45804
- Lima Memorial Hospital
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Maumee, Ohio, Forenede Stater, 43537
- Toledo Radiation Oncology at Northwest Ohio Onocolgy Center
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Maumee, Ohio, Forenede Stater, 43537-1839
- Northwest Ohio Oncology Center
-
Maumee, Ohio, Forenede Stater, 43537
- Saint Luke's Hospital
-
Oregon, Ohio, Forenede Stater, 43616
- Saint Charles Hospital
-
Oregon, Ohio, Forenede Stater, 43616
- Bayview Oncology Associates
-
Sandusky, Ohio, Forenede Stater, 44870
- North Coast Cancer Care
-
Sandusky, Ohio, Forenede Stater, 44870
- Firelands Regional Medical Center
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Sylvania, Ohio, Forenede Stater, 43560
- Flower Memorial Hospital
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Tiffin, Ohio, Forenede Stater, 44883
- Mercy Hospital of Tiffin
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Toledo, Ohio, Forenede Stater, 43608
- Saint Vincent Mercy Medical Center
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Toledo, Ohio, Forenede Stater, 43614
- University of Toledo
-
Toledo, Ohio, Forenede Stater, 43617
- Toledo Community Hospital Oncology Program CCOP
-
Toledo, Ohio, Forenede Stater, 43606
- The Toledo Hospital
-
Toledo, Ohio, Forenede Stater, 43623
- Toledo Clinic
-
Toledo, Ohio, Forenede Stater, 43623
- Stark, Michael, Edward. M.D. (UIA Investigator)
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Toledo, Ohio, Forenede Stater, 43623
- Mercy Cancer Center at Saint Anne Mercy Hospital
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Troy, Ohio, Forenede Stater, 45373
- Upper Valley Medical Center
-
Wauseon, Ohio, Forenede Stater, 43567
- Fulton County Health Center
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Wilmington, Ohio, Forenede Stater, 45177
- Clinton Memorial Hospital
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Xenia, Ohio, Forenede Stater, 45385
- Greene Memorial Hospital
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Pennsylvania
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Allentown, Pennsylvania, Forenede Stater, 18105
- Lehigh Valley Hospital
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Danville, Pennsylvania, Forenede Stater, 17822-2001
- Geisinger Medical Center
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State College, Pennsylvania, Forenede Stater, 16801
- Geisinger Medical Group
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Wilkes-Barre, Pennsylvania, Forenede Stater, 18711
- Geisinger Wyoming Valley
-
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South Carolina
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Anderson, South Carolina, Forenede Stater, 29621
- AnMed Health Hospital
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Spartanburg, South Carolina, Forenede Stater, 29303
- Spartanburg Regional Medical Center
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Spartanburg, South Carolina, Forenede Stater, 29303
- Upstate Carolina CCOP
-
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South Dakota
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Sioux Falls, South Dakota, Forenede Stater, 57105
- Avera Cancer Institute
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Sioux Falls, South Dakota, Forenede Stater, 57105
- Avera McKennan Hospital and University Health Center
-
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Virginia
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Fredericksburg, Virginia, Forenede Stater, 22401
- Fredericksburg Oncology Inc
-
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Wyoming
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Sheridan, Wyoming, Forenede Stater, 82801
- Welch Cancer Center
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Deltagelseskriterier
Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.
Berettigelseskriterier
Aldre berettiget til at studere
18 år og ældre (Voksen, Ældre voksen)
Tager imod sunde frivillige
Ingen
Køn, der er berettiget til at studere
Alle
Beskrivelse
Inclusion Criteria:
Histologically confirmed* mantle cell lymphoma (MCL)
- Relapsed, refractory, or stable disease after prior treatment
- Tumor must be cyclin D-1 by immunohistochemistry OR 11;14 translocation by fluorescent in situ hybridization or cytogenetics
Measurable disease, defined as ≥ 1 of the following:
- Unidimensionally measurable lymph node or tumor mass ≥ 2 cm by CT scan or MRI
- Splenic enlargement if spleen is palpable ≥ 3 cm below the left costal margin
- Malignant lymphocytosis if absolute lymphocytic count ≥ 5,000 AND lymphocytes confirmed to be monoclonal by flow cytometry
- No known central nervous system involvement (e.g., parenchymal mass or leptomeningeal involvement)
- Performance status - Eastern Cooperative Oncology Group (ECOG) 0-2
- At least 3 months
- No other concurrent treatment for MCL
- Absolute neutrophil count ≥ 1,000/mm^3
- Platelet count ≥ 75,000/mm^3
- Total bilirubin ≤ 1.5 times upper limit of normal (ULN)
- Direct bilirubin < 1.5 times ULN
- Aspartate aminotransferase (AST) ≤ 3 times ULN (5 times ULN if liver involvement by MCL is present)
- Creatinine ≤ 2 times ULN
- No symptomatic congestive heart failure
- No unstable angina pectoris
- No cardiac arrhythmia
- Not pregnant or nursing
- Negative pregnancy test
- Fertile patients must use effective contraception during and for 3 months after completion of study treatment
- Cholesterol ≤ 350 mg/dL
- Fasting triglycerides < 400 mg/dL
- No known HIV positivity
- No ongoing or active infection
- No psychiatric illness or social situation that would preclude study compliance
- No other uncontrolled illness
- No other active malignancy requiring treatment OR that would preclude assessment of response to study drugs
- Prior biologic response modifiers allowed
- Prior immunotherapy allowed
- Prior high-dose therapy with stem cell support (i.e., stem cell transplantation) allowed
- No concurrent prophylactic growth factor to support neutrophils
- Prior chemotherapy allowed
- No other concurrent chemotherapy
No concurrent corticosteroids to induce an antitumor response
- Concurrent corticosteroids (≤ 10 mg/day of prednisone or equivalent) for adrenal insufficiency or acute allergic reactions allowed
- Prior radiotherapy allowed
- No prior treatment with a mammalian target of rapamycin (mTOR) inhibitor
- No other concurrent investigational or commercial agents or therapies for MCL
- No other concurrent immunosuppressive therapy
Studieplan
Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
- Primært formål: Behandling
- Tildeling: N/A
- Interventionel model: Enkelt gruppeopgave
- Maskning: Ingen (Åben etiket)
Våben og indgreb
Deltagergruppe / Arm |
Intervention / Behandling |
|---|---|
|
Eksperimentel: Arm I
Patients receive CCI-779 IV over 30 minutes on days 1, 8, 15, and 22. Patients also receive rituximab IV on days 1, 8, 15, and 22 of course 1 and on day 1 only of courses 3, 5, 7, 9, and 11.
Treatment repeats every 28 days for up to 12 courses in the absence of disease progression or unacceptable toxicity.
After completion of course 3, patients undergo reevaluation.
Patients achieving a CR or an unconfirmed CR (CRu) receive 2 additional courses of treatment for a total of 5 courses.
Patients achieving a PR or stable disease continue study treatment as outlined above for up to 12 courses.
Patients achieving a PR or stable disease who subsequently achieve a CR or CRu between courses 3 and 10 receive 2 additional courses of treatment.
|
375 mg/m^2 Given IV
Andre navne:
25 mg given IV
Andre navne:
|
Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
|
Overall Response Rate (Complete and Partial Responses) as Defined by the International Workshop Criteria
Tidsramme: Up to 12, 28-day cycles.
|
Complete Response (CR) - Complete disappearance of all detectable clinical and radiographic evidence of disease and disappearance of all disease-related symptoms. Partial Response (PR) requires a >=50% decrease in sum of the products of the greatest dimension (SPD) of the six largest dominant nodes or nodal masses. Overall Response Rate (ORR) - The number of patients who achieve a CR or PR divided by the total number of evaluable patients. We report the Overall Response Rate here. |
Up to 12, 28-day cycles.
|
Sekundære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
|
Time to Progression
Tidsramme: Patients were followed up to five years after registration.
|
Time to progression was defined as the time from registration to the date of progression.
Patients who died without disease progression were censored at the date of their last evaluation.
Patients who were still receiving treatment at the time of these analyses were censored at the date of their last evaluation.
The distribution of this time-to-event end point was estimated using the Kaplan-Meier method.
|
Patients were followed up to five years after registration.
|
|
Duration of Response
Tidsramme: Response duration is followed up to 5 years from registration.
|
Duration of response was defined as the time from the date of documented response to the date of progression.
Patients who went off treatment due to other reasons (eg, adverse reactions, refusal of further treatment) were censored at that time.
The distribution of this time-to-event end point was estimated using the Kaplan-Meier method.
|
Response duration is followed up to 5 years from registration.
|
|
Toxicity
Tidsramme: Assessed during treatment (up to 12, 28-day cycles)
|
As per the National Cancer Institute's Common Terminology Criteria for Adverse Events (CTCAE) Version 3, toxicity was defined as adverse events that are classified as either possibly, probably, or definitely related to study treatment by the treating physician. In this section, we report the number of participants that experienced at least one Grade 3 or higher adverse event. |
Assessed during treatment (up to 12, 28-day cycles)
|
|
Overall Survival
Tidsramme: Patients were followed for survival status for up to 5 years.
|
Overall survival (OS) was defined as the time from registration to death resulting from any cause.
The distribution of this time-to-event end point was estimated using the Kaplan-Meier method.
|
Patients were followed for survival status for up to 5 years.
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Samarbejdspartnere og efterforskere
Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.
Sponsor
Efterforskere
- Ledende efterforsker: Stephen Ansell, North Central Cancer Treatment Group
Publikationer og nyttige links
Den person, der er ansvarlig for at indtaste oplysninger om undersøgelsen, leverer frivilligt disse publikationer. Disse kan handle om alt relateret til undersøgelsen.
Datoer for undersøgelser
Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.
Studer store datoer
Studiestart
1. maj 2005
Primær færdiggørelse (Faktiske)
1. september 2009
Studieafslutning (Faktiske)
1. marts 2012
Datoer for studieregistrering
Først indsendt
3. maj 2005
Først indsendt, der opfyldte QC-kriterier
3. maj 2005
Først opslået (Skøn)
4. maj 2005
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Skøn)
17. april 2014
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
21. marts 2014
Sidst verificeret
1. december 2013
Mere information
Begreber relateret til denne undersøgelse
Yderligere relevante MeSH-vilkår
- Sygdomme i immunsystemet
- Neoplasmer efter histologisk type
- Neoplasmer
- Lymfoproliferative lidelser
- Lymfesygdomme
- Immunproliferative lidelser
- Lymfom, Non-Hodgkin
- Lymfom
- Lymfom, kappecelle
- Lægemidlers fysiologiske virkninger
- Anti-infektionsmidler
- Antirheumatiske midler
- Antineoplastiske midler
- Immunsuppressive midler
- Immunologiske faktorer
- Antineoplastiske midler, immunologiske
- Antibakterielle midler
- Antibiotika, antineoplastisk
- Antifungale midler
- Rituximab
- Sirolimus
Andre undersøgelses-id-numre
- NCI-2009-00644
- U10CA025224 (U.S. NIH-bevilling/kontrakt)
- N038H
- CDR0000425334 (Registry Identifier: PDQ (Physician Data Query))
Disse oplysninger blev hentet direkte fra webstedet clinicaltrials.gov uden ændringer. Hvis du har nogen anmodninger om at ændre, fjerne eller opdatere dine undersøgelsesoplysninger, bedes du kontakte register@clinicaltrials.gov. Så snart en ændring er implementeret på clinicaltrials.gov, vil denne også blive opdateret automatisk på vores hjemmeside .
Kliniske forsøg med rituximab
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Children's Oncology GroupNational Cancer Institute (NCI)AfsluttetEBV-relateret post-transplantation lymfoproliferativ lidelse | Monomorf post-transplantation lymfoproliferativ lidelse | Polymorf post-transplantation lymfoproliferativ lidelse | Tilbagevendende monomorf post-transplantation lymfoproliferativ lidelse | Tilbagevendende polymorf post-transplantation... og andre forholdForenede Stater
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National Cancer Institute (NCI)AfsluttetAnn Arbor trin III grad 1 follikulært lymfom | Ann Arbor trin III grad 2 follikulært lymfom | Ann Arbor Stage IV Grad 1 follikulært lymfom | Ann Arbor trin IV grad 2 follikulært lymfom | Ann Arbor Stage II Grade 3 Contiguous Follicular Lymfom | Ann Arbor Stage II Grade 3 Non-Contiguous Follikulær... og andre forholdForenede Stater
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M.D. Anderson Cancer CenterNational Cancer Institute (NCI)Aktiv, ikke rekrutterendeTilbagevendende lille lymfocytisk lymfom | Prolymfocytisk leukæmi | Tilbagevendende kronisk lymfatisk leukæmiForenede Stater
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Academic and Community Cancer Research UnitedNational Cancer Institute (NCI)AfsluttetTilbagevendende grad 1 follikulært lymfom | Tilbagevendende grad 2 follikulært lymfom | Tilbagevendende kappecellelymfom | Tilbagevendende marginalzone lymfom | Refraktær B-celle non-Hodgkin lymfom | Tilbagevendende lille lymfocytisk lymfom | Tilbagevendende B-celle non-Hodgkin lymfom | Tilbagevendende... og andre forholdForenede Stater
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The First Affiliated Hospital with Nanjing Medical...Ikke rekrutterer endnuDLBCL - Diffust storcellet B-celle lymfom
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Mabion SAParexelTrukket tilbage
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M.D. Anderson Cancer CenterNational Cancer Institute (NCI)Aktiv, ikke rekrutterendeAnn Arbor Stage I Grade 1 Follikulært lymfom | Ann Arbor Stage I Grade 2 Follikulært lymfom | Ann Arbor fase II grad 1 follikulært lymfom | Ann Arbor fase II grad 2 follikulært lymfomForenede Stater
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M.D. Anderson Cancer CenterNational Cancer Institute (NCI)Aktiv, ikke rekrutterendeKronisk lymfatisk leukæmi/lille lymfatisk lymfomForenede Stater
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M.D. Anderson Cancer CenterAktiv, ikke rekrutterendeMantelcellelymfomForenede Stater
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Beijing InnoCare Pharma Tech Co., Ltd.RekrutteringHæmatologiske maligniteterKina