- ICH GCP
- Registro degli studi clinici negli Stati Uniti
- Sperimentazione clinica NCT00109967
CCI-779 and Rituximab in Treating Patients With Relapsed or Refractory Non-Hodgkin's Lymphoma
A Phase II Study of CCI-779 in Combination With Rituximab in Patients With Relapsed or Refractory Mantle Cell Lymphoma
Panoramica dello studio
Stato
Condizioni
Intervento / Trattamento
Descrizione dettagliata
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.
Tipo di studio
Iscrizione (Effettivo)
Fase
- Fase 2
Contatti e Sedi
Luoghi di studio
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Alabama
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Mobile, Alabama, Stati Uniti, 36607
- Mobile Infirmary Medical Center
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Colorado
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Aurora, Colorado, Stati Uniti, 80012
- The Medical Center of Aurora
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Boulder, Colorado, Stati Uniti, 80301
- Boulder Community Hospital
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Colorado Springs, Colorado, Stati Uniti, 80907
- Penrose-Saint Francis Healthcare
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Denver, Colorado, Stati Uniti, 80210
- Porter Adventist Hospital
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Denver, Colorado, Stati Uniti, 80218
- Presbyterian - Saint Lukes Medical Center - Health One
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Denver, Colorado, Stati Uniti, 80220
- Rose Medical Center
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Denver, Colorado, Stati Uniti, 80218
- Exempla Saint Joseph Hospital
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Denver, Colorado, Stati Uniti, 80224-2522
- Colorado Cancer Research Program CCOP
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Denver, Colorado, Stati Uniti, 80204
- Saint Anthony Central Hospital
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Englewood, Colorado, Stati Uniti, 80110
- Swedish Medical Center
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Grand Junction, Colorado, Stati Uniti, 81502
- Saint Mary's Hospital and Regional Medical Center
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Greeley, Colorado, Stati Uniti, 80631
- North Colorado Medical Center
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Lone Tree, Colorado, Stati Uniti, 80124
- Sky Ridge Medical Center
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Longmont, Colorado, Stati Uniti, 80501
- Longmont United Hospital
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Loveland, Colorado, Stati Uniti, 80539
- McKee Medical Center
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Pueblo, Colorado, Stati Uniti, 81004
- Saint Mary Corwin Medical Center
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Thornton, Colorado, Stati Uniti, 80229
- North Suburban Medical Center
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Wheat Ridge, Colorado, Stati Uniti, 80033
- Exempla Lutheran Medical Center
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Illinois
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Aurora, Illinois, Stati Uniti, 60504
- Rush - Copley Medical Center
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Bloomington, Illinois, Stati Uniti, 61701
- Saint Joseph Medical Center
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Canton, Illinois, Stati Uniti, 61520
- Graham Hospital Association
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Carthage, Illinois, Stati Uniti, 62321
- Memorial Hospital
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Eureka, Illinois, Stati Uniti, 61530
- Eureka Hospital
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Galesburg, Illinois, Stati Uniti, 61401
- Galesburg Cottage Hospital
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Galesburg, Illinois, Stati Uniti, 61401
- Galesburg Clinic
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Havana, Illinois, Stati Uniti, 62644
- Mason District Hospital
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Hopedale, Illinois, Stati Uniti, 61747
- Hopedale Medical Complex - Hospital
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Joliet, Illinois, Stati Uniti, 60435
- Joliet Oncology-Hematology Associates Limited
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Kewanee, Illinois, Stati Uniti, 61443
- Kewanee Hospital
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Macomb, Illinois, Stati Uniti, 61455
- Mcdonough District Hospital
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Normal, Illinois, Stati Uniti, 61761
- Community Cancer Center Foundation
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Normal, Illinois, Stati Uniti, 61761
- Bromenn Regional Medical Center
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Ottawa, Illinois, Stati Uniti, 61350
- Illinois CancerCare-Ottawa Clinic
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Ottawa, Illinois, Stati Uniti, 61350
- Ottawa Regional Hospital and Healthcare Center
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Pekin, Illinois, Stati Uniti, 61554
- Pekin Cancer Treatment Center
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Pekin, Illinois, Stati Uniti, 61554
- Pekin Hospital
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Peoria, Illinois, Stati Uniti, 61637
- OSF Saint Francis Medical Center
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Peoria, Illinois, Stati Uniti, 61615
- Illinois CancerCare-Peoria
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Peoria, Illinois, Stati Uniti, 61614
- Proctor Hospital
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Peoria, Illinois, Stati Uniti, 61603
- Methodist Medical Center of Illinois
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Peoria, Illinois, Stati Uniti, 61615
- Illinois Oncology Research Association CCOP
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Peru, Illinois, Stati Uniti, 61354
- Illinois Valley Hospital
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Princeton, Illinois, Stati Uniti, 61356
- Perry Memorial Hospital
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Spring Valley, Illinois, Stati Uniti, 61362
- Saint Margaret's Hospital
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Urbana, Illinois, Stati Uniti, 61801
- Carle Clinic-Urbana Main
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Urbana, Illinois, Stati Uniti, 61801
- Carle Foundation dba Carle Cancer Center
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Indiana
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Beech Grove, Indiana, Stati Uniti, 46107
- Saint Francis Hospital and Health Centers
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Michigan City, Indiana, Stati Uniti, 46360
- Saint Anthony Memorial Health Center
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Richmond, Indiana, Stati Uniti, 47374
- Reid Hospital and Health Care Services
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Iowa
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Ames, Iowa, Stati Uniti, 50010
- McFarland Clinic
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Cedar Rapids, Iowa, Stati Uniti, 52403
- Mercy Hospital
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Cedar Rapids, Iowa, Stati Uniti, 52402
- Saint Luke's Hospital
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Cedar Rapids, Iowa, Stati Uniti, 52403
- Cedar Rapids Oncology Association
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Cedar Rapids, Iowa, Stati Uniti, 52403
- Oncology Associates
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Clive, Iowa, Stati Uniti, 50325
- Medical Oncology and Hematology Associates-West Des Moines
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Des Moines, Iowa, Stati Uniti, 50309
- Iowa Methodist Medical Center
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Des Moines, Iowa, Stati Uniti, 50314
- Mercy Medical Center - Des Moines
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Des Moines, Iowa, Stati Uniti, 50309
- Medical Oncology and Hematology Associates-Des Moines
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Des Moines, Iowa, Stati Uniti, 50316
- Iowa Lutheran Hospital
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Des Moines, Iowa, Stati Uniti, 50307
- Mercy Capitol
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Des Moines, Iowa, Stati Uniti, 50309
- Iowa Oncology Research Association CCOP
-
Des Moines, Iowa, Stati Uniti, 50314
- Medical Oncology and Hematology Associates
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Mason City, Iowa, Stati Uniti, 50401
- Mercy Medical Center - North Iowa
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Sioux City, Iowa, Stati Uniti, 51104
- Saint Luke's Regional Medical Center
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Sioux City, Iowa, Stati Uniti, 51101-1733
- Siouxland Regional Cancer Center
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Sioux City, Iowa, Stati Uniti, 51104
- Mercy Medical Center-Sioux City
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Sioux City, Iowa, Stati Uniti, 51101
- Siouxland Hematology - Oncology Associates
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Kansas
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Anthony, Kansas, Stati Uniti, 67003
- Hospital District Sixth of Harper County
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Chanute, Kansas, Stati Uniti, 66720
- Cancer Center of Kansas - Chanute
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Dodge City, Kansas, Stati Uniti, 67801
- Cancer Center of Kansas - Dodge City
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El Dorado, Kansas, Stati Uniti, 67042
- Cancer Center of Kansas - El Dorado
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Fort Scott, Kansas, Stati Uniti, 66701
- Cancer Center of Kansas - Fort Scott
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Independence, Kansas, Stati Uniti, 67301
- Cancer Center of Kansas-Independence
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Kingman, Kansas, Stati Uniti, 67068
- Cancer Center of Kansas-Kingman
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Lawrence, Kansas, Stati Uniti, 66044
- Lawrence Memorial Hospital
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Newton, Kansas, Stati Uniti, 67114
- Cancer Center of Kansas - Newton
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Parsons, Kansas, Stati Uniti, 67357
- Cancer Center of Kansas - Parsons
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Pratt, Kansas, Stati Uniti, 67124
- Cancer Center of Kansas - Pratt
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Salina, Kansas, Stati Uniti, 67401
- Cancer Center of Kansas - Salina
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Wellington, Kansas, Stati Uniti, 67152
- Cancer Center of Kansas - Wellington
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Wichita, Kansas, Stati Uniti, 67208
- Cancer Center of Kansas-Wichita Medical Arts Tower
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Wichita, Kansas, Stati Uniti, 67208
- Associates In Womens Health
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Wichita, Kansas, Stati Uniti, 67214
- Cancer Center of Kansas - Main Office
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Wichita, Kansas, Stati Uniti, 67214
- Via Christi Regional Medical Center
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Wichita, Kansas, Stati Uniti, 67214
- Wichita CCOP
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Winfield, Kansas, Stati Uniti, 67156
- Cancer Center of Kansas - Winfield
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Michigan
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Adrian, Michigan, Stati Uniti, 49221
- Bixby Medical Center
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Adrian, Michigan, Stati Uniti, 49221
- Hickman Cancer Center
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Ann Arbor, Michigan, Stati Uniti, 48106-0995
- Saint Joseph Mercy Hospital
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Ann Arbor, Michigan, Stati Uniti, 48106
- Michigan Cancer Research Consortium Community Clinical Oncology Program
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Dearborn, Michigan, Stati Uniti, 48123
- Oakwood Hospital
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Detroit, Michigan, Stati Uniti, 48236
- Saint John Hospital and Medical Center
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Flint, Michigan, Stati Uniti, 48502
- Hurley Medical Center
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Flint, Michigan, Stati Uniti, 48532
- Genesys Regional Medical Center
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Jackson, Michigan, Stati Uniti, 49201
- Allegiance Health
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Lansing, Michigan, Stati Uniti, 48912
- Sparrow Hospital
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Livonia, Michigan, Stati Uniti, 48154
- Saint Mary Mercy Hospital
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Monroe, Michigan, Stati Uniti, 48162
- Mercy Memorial Hospital
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Monroe, Michigan, Stati Uniti, 48162
- Community Cancer Center of Monroe
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Pontiac, Michigan, Stati Uniti, 48341-2985
- Saint Joseph Mercy Oakland
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Port Huron, Michigan, Stati Uniti, 48060
- Saint Joseph Mercy Port Huron
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Saginaw, Michigan, Stati Uniti, 48601
- Saint Mary's of Michigan
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Warren, Michigan, Stati Uniti, 48093
- Saint John Macomb-Oakland Hospital
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Minnesota
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Bemidji, Minnesota, Stati Uniti, 56601
- Merit Care Clinic Bemidji
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Burnsville, Minnesota, Stati Uniti, 55337
- Fairview Ridges Hospital
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Coon Rapids, Minnesota, Stati Uniti, 55433
- Mercy Hospital
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Duluth, Minnesota, Stati Uniti, 55805
- Miller-Dwan Hospital
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Duluth, Minnesota, Stati Uniti, 55805
- Saint Mary's Medical Center
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Duluth, Minnesota, Stati Uniti, 55805
- Duluth Clinic CCOP
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Edina, Minnesota, Stati Uniti, 55435
- Fairview-Southdale Hospital
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Fridley, Minnesota, Stati Uniti, 55432
- Unity Hospital
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Maplewood, Minnesota, Stati Uniti, 55109
- Minnesota Oncology Hematology PA-Maplewood
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Minneapolis, Minnesota, Stati Uniti, 55407
- Abbott-Northwestern Hospital
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Robbinsdale, Minnesota, Stati Uniti, 55422
- North Memorial Medical Health Center
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Rochester, Minnesota, Stati Uniti, 55905
- Mayo Clinic
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Saint Louis Park, Minnesota, Stati Uniti, 55416
- Park Nicollet Clinic - Saint Louis Park
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Saint Louis Park, Minnesota, Stati Uniti, 55416
- Metro-Minnesota CCOP
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Saint Paul, Minnesota, Stati Uniti, 55102
- United Hospital
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Shakopee, Minnesota, Stati Uniti, 55379
- Saint Francis Regional Medical Center
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Waconia, Minnesota, Stati Uniti, 55387
- Ridgeview Medical Center
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Woodbury, Minnesota, Stati Uniti, 55125
- Minnesota Oncology and Hematology PA-Woodbury
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Montana
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Billings, Montana, Stati Uniti, 59101
- Saint Vincent Healthcare
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Billings, Montana, Stati Uniti, 59101
- Northern Rockies Radiation Oncology Center
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Billings, Montana, Stati Uniti, 59101
- Montana Cancer Consortium CCOP
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Billings, Montana, Stati Uniti, 59107-7000
- Billings Clinic
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Billings, Montana, Stati Uniti, 59107
- Deaconess Medical Center
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Billings, Montana, Stati Uniti, 59101
- Hematology-Oncology Centers of the Northern Rockies PC
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Bozeman, Montana, Stati Uniti, 59715
- Bozeman Deaconess Hospital
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Bozeman, Montana, Stati Uniti, 59715
- Bozeman Deaconess Cancer Center
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Butte, Montana, Stati Uniti, 59701
- Saint James Community Hospital and Cancer Treatment Center
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Great Falls, Montana, Stati Uniti, 59405
- Great Falls Clinic
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Great Falls, Montana, Stati Uniti, 59405
- Berdeaux, Donald MD (UIA Investigator)
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Havre, Montana, Stati Uniti, 59501
- Northern Montana Hospital
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Helena, Montana, Stati Uniti, 59601
- Saint Peter's Community Hospital
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Kalispell, Montana, Stati Uniti, 59901
- Kalispell Regional Medical Center
-
Kalispell, Montana, Stati Uniti, 59901
- Glacier Oncology PLLC
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Kalispell, Montana, Stati Uniti, 59901
- Kalispell Medical Oncology
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Missoula, Montana, Stati Uniti, 59802
- Saint Patrick Hospital - Community Hospital
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Missoula, Montana, Stati Uniti, 59804
- Guardian Oncology and Center for Wellness
-
Missoula, Montana, Stati Uniti, 59801
- Community Medical Hospital
-
Missoula, Montana, Stati Uniti, 59802
- Montana Cancer Specialists
-
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North Carolina
-
Rutherfordton, North Carolina, Stati Uniti, 28139
- Rutherford Hospital
-
-
North Dakota
-
Bismarck, North Dakota, Stati Uniti, 58501
- Bismarck Cancer Center
-
Bismarck, North Dakota, Stati Uniti, 58501
- Mid Dakota Clinic
-
Bismarck, North Dakota, Stati Uniti, 58501
- Saint Alexius Medical Center
-
Bismarck, North Dakota, Stati Uniti, 58501
- Medcenter One Health Systems
-
Fargo, North Dakota, Stati Uniti, 58122
- MeritCare Medical Group
-
Fargo, North Dakota, Stati Uniti, 58122
- Meritcare Hospital
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Ohio
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Bowling Green, Ohio, Stati Uniti, 43402
- Wood County Oncology Center
-
Dayton, Ohio, Stati Uniti, 45406
- Good Samaritan Hospital - Dayton
-
Dayton, Ohio, Stati Uniti, 45409
- Miami Valley Hospital
-
Dayton, Ohio, Stati Uniti, 45415
- Samaritan North Health Center
-
Dayton, Ohio, Stati Uniti, 45405
- Grandview Hospital
-
Dayton, Ohio, Stati Uniti, 45428
- Veteran Affairs Medical Center
-
Dayton, Ohio, Stati Uniti, 45429
- Dayton CCOP
-
Elyria, Ohio, Stati Uniti, 44035
- Hematology Oncology Center Incorporated
-
Findlay, Ohio, Stati Uniti, 45840
- Blanchard Valley Hospital
-
Franklin, Ohio, Stati Uniti, 45005-1066
- Atrium Medical Center-Middletown Regional Hospital
-
Fremont, Ohio, Stati Uniti, 43420
- Fremont Memorial Hospital
-
Greenville, Ohio, Stati Uniti, 45331
- Wayne Hospital
-
Kenton, Ohio, Stati Uniti, 43326
- Cole, Sharon, K. M.D. (UIA Investigator)
-
Kettering, Ohio, Stati Uniti, 45429
- Kettering Medical Center
-
Lima, Ohio, Stati Uniti, 45804
- Lima Memorial Hospital
-
Maumee, Ohio, Stati Uniti, 43537
- Toledo Radiation Oncology at Northwest Ohio Onocolgy Center
-
Maumee, Ohio, Stati Uniti, 43537-1839
- Northwest Ohio Oncology Center
-
Maumee, Ohio, Stati Uniti, 43537
- Saint Luke's Hospital
-
Oregon, Ohio, Stati Uniti, 43616
- Saint Charles Hospital
-
Oregon, Ohio, Stati Uniti, 43616
- Bayview Oncology Associates
-
Sandusky, Ohio, Stati Uniti, 44870
- North Coast Cancer Care
-
Sandusky, Ohio, Stati Uniti, 44870
- Firelands Regional Medical Center
-
Sylvania, Ohio, Stati Uniti, 43560
- Flower Memorial Hospital
-
Tiffin, Ohio, Stati Uniti, 44883
- Mercy Hospital of Tiffin
-
Toledo, Ohio, Stati Uniti, 43608
- Saint Vincent Mercy Medical Center
-
Toledo, Ohio, Stati Uniti, 43614
- University of Toledo
-
Toledo, Ohio, Stati Uniti, 43617
- Toledo Community Hospital Oncology Program CCOP
-
Toledo, Ohio, Stati Uniti, 43606
- The Toledo Hospital
-
Toledo, Ohio, Stati Uniti, 43623
- Toledo Clinic
-
Toledo, Ohio, Stati Uniti, 43623
- Stark, Michael, Edward. M.D. (UIA Investigator)
-
Toledo, Ohio, Stati Uniti, 43623
- Mercy Cancer Center at Saint Anne Mercy Hospital
-
Troy, Ohio, Stati Uniti, 45373
- Upper Valley Medical Center
-
Wauseon, Ohio, Stati Uniti, 43567
- Fulton County Health Center
-
Wilmington, Ohio, Stati Uniti, 45177
- Clinton Memorial Hospital
-
Xenia, Ohio, Stati Uniti, 45385
- Greene Memorial Hospital
-
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Pennsylvania
-
Allentown, Pennsylvania, Stati Uniti, 18105
- LeHigh Valley Hospital
-
Danville, Pennsylvania, Stati Uniti, 17822-2001
- Geisinger Medical Center
-
State College, Pennsylvania, Stati Uniti, 16801
- Geisinger Medical Group
-
Wilkes-Barre, Pennsylvania, Stati Uniti, 18711
- Geisinger Wyoming Valley
-
-
South Carolina
-
Anderson, South Carolina, Stati Uniti, 29621
- AnMed Health Hospital
-
Spartanburg, South Carolina, Stati Uniti, 29303
- Spartanburg Regional Medical Center
-
Spartanburg, South Carolina, Stati Uniti, 29303
- Upstate Carolina CCOP
-
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South Dakota
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Sioux Falls, South Dakota, Stati Uniti, 57105
- Avera Cancer Institute
-
Sioux Falls, South Dakota, Stati Uniti, 57105
- Avera McKennan Hospital and University Health Center
-
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Virginia
-
Fredericksburg, Virginia, Stati Uniti, 22401
- Fredericksburg Oncology Inc
-
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Wyoming
-
Sheridan, Wyoming, Stati Uniti, 82801
- Welch Cancer Center
-
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Criteri di partecipazione
Criteri di ammissibilità
Età idonea allo studio
Accetta volontari sani
Sessi ammissibili allo studio
Descrizione
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
Piano di studio
Come è strutturato lo studio?
Dettagli di progettazione
- Scopo principale: Trattamento
- Assegnazione: N / A
- Modello interventistico: Assegnazione di gruppo singolo
- Mascheramento: Nessuno (etichetta aperta)
Armi e interventi
Gruppo di partecipanti / Arm |
Intervento / Trattamento |
---|---|
Sperimentale: 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
Altri nomi:
25 mg given IV
Altri nomi:
|
Cosa sta misurando lo studio?
Misure di risultato primarie
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
---|---|---|
Overall Response Rate (Complete and Partial Responses) as Defined by the International Workshop Criteria
Lasso di tempo: 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.
|
Misure di risultato secondarie
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
---|---|---|
Time to Progression
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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.
|
Collaboratori e investigatori
Sponsor
Investigatori
- Investigatore principale: Stephen Ansell, North Central Cancer Treatment Group
Pubblicazioni e link utili
Studiare le date dei record
Studia le date principali
Inizio studio
Completamento primario (Effettivo)
Completamento dello studio (Effettivo)
Date di iscrizione allo studio
Primo inviato
Primo inviato che soddisfa i criteri di controllo qualità
Primo Inserito (Stima)
Aggiornamenti dei record di studio
Ultimo aggiornamento pubblicato (Stima)
Ultimo aggiornamento inviato che soddisfa i criteri QC
Ultimo verificato
Maggiori informazioni
Termini relativi a questo studio
Termini MeSH pertinenti aggiuntivi
- Malattie del sistema immunitario
- Neoplasie per tipo istologico
- Neoplasie
- Malattie linfoproliferative
- Malattie linfatiche
- Disturbi immunoproliferativi
- Linfoma non Hodgkin
- Linfoma
- Linfoma, cellule del mantello
- Effetti fisiologici delle droghe
- Agenti antinfettivi
- Agenti antireumatici
- Agenti antineoplastici
- Agenti immunosoppressivi
- Fattori immunologici
- Agenti antineoplastici, immunologici
- Agenti antibatterici
- Antibiotici, Antineoplastici
- Agenti antimicotici
- Rituximab
- Sirolimo
Altri numeri di identificazione dello studio
- NCI-2009-00644
- U10CA025224 (Sovvenzione/contratto NIH degli Stati Uniti)
- N038H
- CDR0000425334 (Identificatore di registro: PDQ (Physician Data Query))
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Prove cliniche su rituximab
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Children's Oncology GroupNational Cancer Institute (NCI)Attivo, non reclutanteDisturbo linfoproliferativo post-trapianto correlato all'EBV | Disturbo linfoproliferativo post-trapianto monomorfico | Disordine linfoproliferativo post-trapianto polimorfico | Disturbo linfoproliferativo post-trapianto monomorfico ricorrente | Disturbo linfoproliferativo post-trapianto polimorfico... e altre condizioniStati Uniti
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M.D. Anderson Cancer CenterNational Cancer Institute (NCI)ReclutamentoLinfoma follicolare di Ann Arbor stadio I grado 1 | Linfoma follicolare di stadio I grado 2 di Ann Arbor | Linfoma follicolare di grado 1 di stadio II di Ann Arbor | Linfoma follicolare di Ann Arbor stadio II grado 2Stati Uniti
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M.D. Anderson Cancer CenterNational Cancer Institute (NCI)Attivo, non reclutantePiccolo linfoma linfocitico ricorrente | Leucemia prolinfocitica | Leucemia linfocitica cronica ricorrenteStati Uniti
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Academic and Community Cancer Research UnitedNational Cancer Institute (NCI)Attivo, non reclutanteLinfoma follicolare ricorrente di grado 1 | Linfoma follicolare ricorrente di grado 2 | Linfoma Mantellare Ricorrente | Linfoma ricorrente della zona marginale | Linfoma non Hodgkin a cellule B refrattario | Piccolo linfoma linfocitico ricorrente | Linfoma non Hodgkin ricorrente a cellule B | Linfoma... e altre condizioniStati Uniti
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National Cancer Institute (NCI)CompletatoLinfoma follicolare di Ann Arbor stadio III grado 1 | Linfoma follicolare di stadio III grado 2 di Ann Arbor | Linfoma follicolare di Ann Arbor stadio IV grado 1 | Linfoma follicolare di stadio IV grado 2 di Ann Arbor | Linfoma follicolare contiguo di grado 3 di stadio II di Ann Arbor | Linfoma... e altre condizioniStati Uniti
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National Cancer Institute (NCI)Celgene CorporationAttivo, non reclutanteLinfoma follicolare di Ann Arbor stadio III grado 1 | Linfoma follicolare di stadio III grado 2 di Ann Arbor | Linfoma follicolare di Ann Arbor stadio IV grado 1 | Linfoma follicolare di stadio IV grado 2 di Ann Arbor | Linfoma follicolare contiguo di grado 3 di stadio II di Ann Arbor | Linfoma... e altre condizioniStati Uniti
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National Cancer Institute (NCI)Attivo, non reclutanteLinfoma Mantellare Ricorrente | Linfoma non Hodgkin a cellule B refrattario | Linfoma non Hodgkin ricorrente a cellule B | Linfoma mantellare refrattarioStati Uniti
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Mabion SAParexelRitirato
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National Cancer Institute (NCI)Attivo, non reclutanteLeucemia linfocitica cronica di stadio I | Leucemia linfocitica cronica di stadio II | Leucemia linfocitica cronica di stadio III | Leucemia linfocitica cronica di stadio IVStati Uniti, Canada
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M.D. Anderson Cancer CenterNational Cancer Institute (NCI)ReclutamentoLeucemia linfocitica cronica/piccolo linfoma linfociticoStati Uniti