CCI-779 and Rituximab in Treating Patients With Relapsed or Refractory Non-Hodgkin's Lymphoma
21 mars 2014 mis à jour par: 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
Aperçu de l'étude
Statut
Complété
Les conditions
Intervention / Traitement
Description détaillée
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.
Type d'étude
Interventionnel
Inscription (Réel)
71
Phase
- Phase 2
Contacts et emplacements
Cette section fournit les coordonnées de ceux qui mènent l'étude et des informations sur le lieu où cette étude est menée.
Lieux d'étude
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Alabama
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Mobile, Alabama, États-Unis, 36607
- Mobile Infirmary Medical Center
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Colorado
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Aurora, Colorado, États-Unis, 80012
- The Medical Center of Aurora
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Boulder, Colorado, États-Unis, 80301
- Boulder Community Hospital
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Colorado Springs, Colorado, États-Unis, 80907
- Penrose-Saint Francis Healthcare
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Denver, Colorado, États-Unis, 80210
- Porter Adventist Hospital
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Denver, Colorado, États-Unis, 80218
- Presbyterian - Saint Lukes Medical Center - Health One
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Denver, Colorado, États-Unis, 80220
- Rose Medical Center
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Denver, Colorado, États-Unis, 80218
- Exempla Saint Joseph Hospital
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Denver, Colorado, États-Unis, 80224-2522
- Colorado Cancer Research Program CCOP
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Denver, Colorado, États-Unis, 80204
- Saint Anthony Central Hospital
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Englewood, Colorado, États-Unis, 80110
- Swedish Medical Center
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Grand Junction, Colorado, États-Unis, 81502
- Saint Mary's Hospital and Regional Medical Center
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Greeley, Colorado, États-Unis, 80631
- North Colorado Medical Center
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Lone Tree, Colorado, États-Unis, 80124
- Sky Ridge Medical Center
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Longmont, Colorado, États-Unis, 80501
- Longmont United Hospital
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Loveland, Colorado, États-Unis, 80539
- McKee Medical Center
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Pueblo, Colorado, États-Unis, 81004
- Saint Mary Corwin Medical Center
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Thornton, Colorado, États-Unis, 80229
- North Suburban Medical Center
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Wheat Ridge, Colorado, États-Unis, 80033
- Exempla Lutheran Medical Center
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Illinois
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Aurora, Illinois, États-Unis, 60504
- Rush - Copley Medical Center
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Bloomington, Illinois, États-Unis, 61701
- Saint Joseph Medical Center
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Canton, Illinois, États-Unis, 61520
- Graham Hospital Association
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Carthage, Illinois, États-Unis, 62321
- Memorial Hospital
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Eureka, Illinois, États-Unis, 61530
- Eureka Hospital
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Galesburg, Illinois, États-Unis, 61401
- Galesburg Cottage Hospital
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Galesburg, Illinois, États-Unis, 61401
- Galesburg Clinic
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Havana, Illinois, États-Unis, 62644
- Mason District Hospital
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Hopedale, Illinois, États-Unis, 61747
- Hopedale Medical Complex - Hospital
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Joliet, Illinois, États-Unis, 60435
- Joliet Oncology-Hematology Associates Limited
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Kewanee, Illinois, États-Unis, 61443
- Kewanee Hospital
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Macomb, Illinois, États-Unis, 61455
- Mcdonough District Hospital
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Normal, Illinois, États-Unis, 61761
- Community Cancer Center Foundation
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Normal, Illinois, États-Unis, 61761
- Bromenn Regional Medical Center
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Ottawa, Illinois, États-Unis, 61350
- Illinois CancerCare-Ottawa Clinic
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Ottawa, Illinois, États-Unis, 61350
- Ottawa Regional Hospital and Healthcare Center
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Pekin, Illinois, États-Unis, 61554
- Pekin Cancer Treatment Center
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Pekin, Illinois, États-Unis, 61554
- Pekin Hospital
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Peoria, Illinois, États-Unis, 61637
- OSF Saint Francis Medical Center
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Peoria, Illinois, États-Unis, 61615
- Illinois CancerCare-Peoria
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Peoria, Illinois, États-Unis, 61614
- Proctor Hospital
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Peoria, Illinois, États-Unis, 61603
- Methodist Medical Center of Illinois
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Peoria, Illinois, États-Unis, 61615
- Illinois Oncology Research Association CCOP
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Peru, Illinois, États-Unis, 61354
- Illinois Valley Hospital
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Princeton, Illinois, États-Unis, 61356
- Perry Memorial Hospital
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Spring Valley, Illinois, États-Unis, 61362
- Saint Margaret's Hospital
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Urbana, Illinois, États-Unis, 61801
- Carle Clinic-Urbana Main
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Urbana, Illinois, États-Unis, 61801
- Carle Foundation dba Carle Cancer Center
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Indiana
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Beech Grove, Indiana, États-Unis, 46107
- Saint Francis Hospital and Health Centers
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Michigan City, Indiana, États-Unis, 46360
- Saint Anthony Memorial Health Center
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Richmond, Indiana, États-Unis, 47374
- Reid Hospital and Health Care Services
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Iowa
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Ames, Iowa, États-Unis, 50010
- McFarland Clinic
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Cedar Rapids, Iowa, États-Unis, 52403
- Mercy Hospital
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Cedar Rapids, Iowa, États-Unis, 52402
- Saint Luke's Hospital
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Cedar Rapids, Iowa, États-Unis, 52403
- Cedar Rapids Oncology Association
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Cedar Rapids, Iowa, États-Unis, 52403
- Oncology Associates
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Clive, Iowa, États-Unis, 50325
- Medical Oncology and Hematology Associates-West Des Moines
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Des Moines, Iowa, États-Unis, 50309
- Iowa Methodist Medical Center
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Des Moines, Iowa, États-Unis, 50314
- Mercy Medical Center - Des Moines
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Des Moines, Iowa, États-Unis, 50309
- Medical Oncology and Hematology Associates-Des Moines
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Des Moines, Iowa, États-Unis, 50316
- Iowa Lutheran Hospital
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Des Moines, Iowa, États-Unis, 50307
- Mercy Capitol
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Des Moines, Iowa, États-Unis, 50309
- Iowa Oncology Research Association CCOP
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Des Moines, Iowa, États-Unis, 50314
- Medical Oncology and Hematology Associates
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Mason City, Iowa, États-Unis, 50401
- Mercy Medical Center - North Iowa
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Sioux City, Iowa, États-Unis, 51104
- Saint Luke's Regional Medical Center
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Sioux City, Iowa, États-Unis, 51101-1733
- Siouxland Regional Cancer Center
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Sioux City, Iowa, États-Unis, 51104
- Mercy Medical Center-Sioux City
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Sioux City, Iowa, États-Unis, 51101
- Siouxland Hematology - Oncology Associates
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Kansas
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Anthony, Kansas, États-Unis, 67003
- Hospital District Sixth of Harper County
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Chanute, Kansas, États-Unis, 66720
- Cancer Center of Kansas - Chanute
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Dodge City, Kansas, États-Unis, 67801
- Cancer Center of Kansas - Dodge City
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El Dorado, Kansas, États-Unis, 67042
- Cancer Center of Kansas - El Dorado
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Fort Scott, Kansas, États-Unis, 66701
- Cancer Center of Kansas - Fort Scott
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Independence, Kansas, États-Unis, 67301
- Cancer Center of Kansas-Independence
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Kingman, Kansas, États-Unis, 67068
- Cancer Center of Kansas-Kingman
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Lawrence, Kansas, États-Unis, 66044
- Lawrence Memorial Hospital
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Newton, Kansas, États-Unis, 67114
- Cancer Center of Kansas - Newton
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Parsons, Kansas, États-Unis, 67357
- Cancer Center of Kansas - Parsons
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Pratt, Kansas, États-Unis, 67124
- Cancer Center of Kansas - Pratt
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Salina, Kansas, États-Unis, 67401
- Cancer Center of Kansas - Salina
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Wellington, Kansas, États-Unis, 67152
- Cancer Center of Kansas - Wellington
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Wichita, Kansas, États-Unis, 67208
- Cancer Center of Kansas-Wichita Medical Arts Tower
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Wichita, Kansas, États-Unis, 67208
- Associates In Womens Health
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Wichita, Kansas, États-Unis, 67214
- Cancer Center of Kansas - Main Office
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Wichita, Kansas, États-Unis, 67214
- Via Christi Regional Medical Center
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Wichita, Kansas, États-Unis, 67214
- Wichita CCOP
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Winfield, Kansas, États-Unis, 67156
- Cancer Center of Kansas - Winfield
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Michigan
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Adrian, Michigan, États-Unis, 49221
- Bixby Medical Center
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Adrian, Michigan, États-Unis, 49221
- Hickman Cancer Center
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Ann Arbor, Michigan, États-Unis, 48106-0995
- Saint Joseph Mercy Hospital
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Ann Arbor, Michigan, États-Unis, 48106
- Michigan Cancer Research Consortium Community Clinical Oncology Program
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Dearborn, Michigan, États-Unis, 48123
- Oakwood Hospital
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Detroit, Michigan, États-Unis, 48236
- Saint John Hospital and Medical Center
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Flint, Michigan, États-Unis, 48502
- Hurley Medical Center
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Flint, Michigan, États-Unis, 48532
- Genesys Regional Medical Center
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Jackson, Michigan, États-Unis, 49201
- Allegiance Health
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Lansing, Michigan, États-Unis, 48912
- Sparrow Hospital
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Livonia, Michigan, États-Unis, 48154
- Saint Mary Mercy Hospital
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Monroe, Michigan, États-Unis, 48162
- Mercy Memorial Hospital
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Monroe, Michigan, États-Unis, 48162
- Community Cancer Center of Monroe
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Pontiac, Michigan, États-Unis, 48341-2985
- Saint Joseph Mercy Oakland
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Port Huron, Michigan, États-Unis, 48060
- Saint Joseph Mercy Port Huron
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Saginaw, Michigan, États-Unis, 48601
- Saint Mary's of Michigan
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Warren, Michigan, États-Unis, 48093
- Saint John Macomb-Oakland Hospital
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Minnesota
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Bemidji, Minnesota, États-Unis, 56601
- Merit Care Clinic Bemidji
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Burnsville, Minnesota, États-Unis, 55337
- Fairview Ridges Hospital
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Coon Rapids, Minnesota, États-Unis, 55433
- Mercy Hospital
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Duluth, Minnesota, États-Unis, 55805
- Miller-Dwan Hospital
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Duluth, Minnesota, États-Unis, 55805
- Saint Mary's Medical Center
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Duluth, Minnesota, États-Unis, 55805
- Duluth Clinic CCOP
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Edina, Minnesota, États-Unis, 55435
- Fairview-Southdale Hospital
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Fridley, Minnesota, États-Unis, 55432
- Unity Hospital
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Maplewood, Minnesota, États-Unis, 55109
- Minnesota Oncology Hematology PA-Maplewood
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Minneapolis, Minnesota, États-Unis, 55407
- Abbott-Northwestern Hospital
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Robbinsdale, Minnesota, États-Unis, 55422
- North Memorial Medical Health Center
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Rochester, Minnesota, États-Unis, 55905
- Mayo Clinic
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Saint Louis Park, Minnesota, États-Unis, 55416
- Park Nicollet Clinic - Saint Louis Park
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Saint Louis Park, Minnesota, États-Unis, 55416
- Metro-Minnesota CCOP
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Saint Paul, Minnesota, États-Unis, 55102
- United Hospital
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Shakopee, Minnesota, États-Unis, 55379
- Saint Francis Regional Medical Center
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Waconia, Minnesota, États-Unis, 55387
- Ridgeview Medical Center
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Woodbury, Minnesota, États-Unis, 55125
- Minnesota Oncology and Hematology PA-Woodbury
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Montana
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Billings, Montana, États-Unis, 59101
- Saint Vincent Healthcare
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Billings, Montana, États-Unis, 59101
- Northern Rockies Radiation Oncology Center
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Billings, Montana, États-Unis, 59101
- Montana Cancer Consortium CCOP
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Billings, Montana, États-Unis, 59107-7000
- Billings Clinic
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Billings, Montana, États-Unis, 59107
- Deaconess Medical Center
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Billings, Montana, États-Unis, 59101
- Hematology-Oncology Centers of the Northern Rockies PC
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Bozeman, Montana, États-Unis, 59715
- Bozeman Deaconess Hospital
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Bozeman, Montana, États-Unis, 59715
- Bozeman Deaconess Cancer Center
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Butte, Montana, États-Unis, 59701
- Saint James Community Hospital and Cancer Treatment Center
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Great Falls, Montana, États-Unis, 59405
- Great Falls Clinic
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Great Falls, Montana, États-Unis, 59405
- Berdeaux, Donald MD (UIA Investigator)
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Havre, Montana, États-Unis, 59501
- Northern Montana Hospital
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Helena, Montana, États-Unis, 59601
- Saint Peter's Community Hospital
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Kalispell, Montana, États-Unis, 59901
- Kalispell Regional Medical Center
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Kalispell, Montana, États-Unis, 59901
- Glacier Oncology PLLC
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Kalispell, Montana, États-Unis, 59901
- Kalispell Medical Oncology
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Missoula, Montana, États-Unis, 59802
- Saint Patrick Hospital - Community Hospital
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Missoula, Montana, États-Unis, 59804
- Guardian Oncology and Center for Wellness
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Missoula, Montana, États-Unis, 59801
- Community Medical Hospital
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Missoula, Montana, États-Unis, 59802
- Montana Cancer Specialists
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North Carolina
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Rutherfordton, North Carolina, États-Unis, 28139
- Rutherford Hospital
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North Dakota
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Bismarck, North Dakota, États-Unis, 58501
- Bismarck Cancer Center
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Bismarck, North Dakota, États-Unis, 58501
- Mid Dakota Clinic
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Bismarck, North Dakota, États-Unis, 58501
- Saint Alexius Medical Center
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Bismarck, North Dakota, États-Unis, 58501
- Medcenter One Health Systems
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Fargo, North Dakota, États-Unis, 58122
- MeritCare Medical Group
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Fargo, North Dakota, États-Unis, 58122
- Meritcare Hospital
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Ohio
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Bowling Green, Ohio, États-Unis, 43402
- Wood County Oncology Center
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Dayton, Ohio, États-Unis, 45406
- Good Samaritan Hospital - Dayton
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Dayton, Ohio, États-Unis, 45409
- Miami Valley Hospital
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Dayton, Ohio, États-Unis, 45415
- Samaritan North Health Center
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Dayton, Ohio, États-Unis, 45405
- Grandview Hospital
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Dayton, Ohio, États-Unis, 45428
- Veteran Affairs Medical Center
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Dayton, Ohio, États-Unis, 45429
- Dayton CCOP
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Elyria, Ohio, États-Unis, 44035
- Hematology Oncology Center Incorporated
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Findlay, Ohio, États-Unis, 45840
- Blanchard Valley Hospital
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Franklin, Ohio, États-Unis, 45005-1066
- Atrium Medical Center-Middletown Regional Hospital
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Fremont, Ohio, États-Unis, 43420
- Fremont Memorial Hospital
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Greenville, Ohio, États-Unis, 45331
- Wayne Hospital
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Kenton, Ohio, États-Unis, 43326
- Cole, Sharon, K. M.D. (UIA Investigator)
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Kettering, Ohio, États-Unis, 45429
- Kettering Medical Center
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Lima, Ohio, États-Unis, 45804
- Lima Memorial Hospital
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Maumee, Ohio, États-Unis, 43537
- Toledo Radiation Oncology at Northwest Ohio Onocolgy Center
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Maumee, Ohio, États-Unis, 43537-1839
- Northwest Ohio Oncology Center
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Maumee, Ohio, États-Unis, 43537
- Saint Luke's Hospital
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Oregon, Ohio, États-Unis, 43616
- Saint Charles Hospital
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Oregon, Ohio, États-Unis, 43616
- Bayview Oncology Associates
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Sandusky, Ohio, États-Unis, 44870
- North Coast Cancer Care
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Sandusky, Ohio, États-Unis, 44870
- Firelands Regional Medical Center
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Sylvania, Ohio, États-Unis, 43560
- Flower Memorial Hospital
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Tiffin, Ohio, États-Unis, 44883
- Mercy Hospital of Tiffin
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Toledo, Ohio, États-Unis, 43608
- Saint Vincent Mercy Medical Center
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Toledo, Ohio, États-Unis, 43614
- University of Toledo
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Toledo, Ohio, États-Unis, 43617
- Toledo Community Hospital Oncology Program CCOP
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Toledo, Ohio, États-Unis, 43606
- The Toledo Hospital
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Toledo, Ohio, États-Unis, 43623
- Toledo Clinic
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Toledo, Ohio, États-Unis, 43623
- Stark, Michael, Edward. M.D. (UIA Investigator)
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Toledo, Ohio, États-Unis, 43623
- Mercy Cancer Center at Saint Anne Mercy Hospital
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Troy, Ohio, États-Unis, 45373
- Upper Valley Medical Center
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Wauseon, Ohio, États-Unis, 43567
- Fulton County Health Center
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Wilmington, Ohio, États-Unis, 45177
- Clinton Memorial Hospital
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Xenia, Ohio, États-Unis, 45385
- Greene Memorial Hospital
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Pennsylvania
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Allentown, Pennsylvania, États-Unis, 18105
- Lehigh Valley Hospital
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Danville, Pennsylvania, États-Unis, 17822-2001
- Geisinger Medical Center
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State College, Pennsylvania, États-Unis, 16801
- Geisinger Medical Group
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Wilkes-Barre, Pennsylvania, États-Unis, 18711
- Geisinger Wyoming Valley
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South Carolina
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Anderson, South Carolina, États-Unis, 29621
- AnMed Health Hospital
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Spartanburg, South Carolina, États-Unis, 29303
- Spartanburg Regional Medical Center
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Spartanburg, South Carolina, États-Unis, 29303
- Upstate Carolina CCOP
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South Dakota
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Sioux Falls, South Dakota, États-Unis, 57105
- Avera Cancer Institute
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Sioux Falls, South Dakota, États-Unis, 57105
- Avera McKennan Hospital and University Health Center
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Virginia
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Fredericksburg, Virginia, États-Unis, 22401
- Fredericksburg Oncology Inc
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Wyoming
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Sheridan, Wyoming, États-Unis, 82801
- Welch Cancer Center
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Critères de participation
Les chercheurs recherchent des personnes qui correspondent à une certaine description, appelée critères d'éligibilité. Certains exemples de ces critères sont l'état de santé général d'une personne ou des traitements antérieurs.
Critère d'éligibilité
Âges éligibles pour étudier
18 ans et plus (Adulte, Adulte plus âgé)
Accepte les volontaires sains
Non
Sexes éligibles pour l'étude
Tout
La description
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
Plan d'étude
Cette section fournit des détails sur le plan d'étude, y compris la façon dont l'étude est conçue et ce que l'étude mesure.
Comment l'étude est-elle conçue ?
Détails de conception
- Objectif principal: Traitement
- Répartition: N / A
- Modèle interventionnel: Affectation à un seul groupe
- Masquage: Aucun (étiquette ouverte)
Armes et Interventions
Groupe de participants / Bras |
Intervention / Traitement |
|---|---|
|
Expérimental: 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
Autres noms:
25 mg given IV
Autres noms:
|
Que mesure l'étude ?
Principaux critères de jugement
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
|
Overall Response Rate (Complete and Partial Responses) as Defined by the International Workshop Criteria
Délai: 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.
|
Mesures de résultats secondaires
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
|
Time to Progression
Délai: 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
Délai: 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
Délai: 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
Délai: 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.
|
Collaborateurs et enquêteurs
C'est ici que vous trouverez les personnes et les organisations impliquées dans cette étude.
Parrainer
Les enquêteurs
- Chercheur principal: Stephen Ansell, North Central Cancer Treatment Group
Publications et liens utiles
La personne responsable de la saisie des informations sur l'étude fournit volontairement ces publications. Il peut s'agir de tout ce qui concerne l'étude.
Dates d'enregistrement des études
Ces dates suivent la progression des dossiers d'étude et des soumissions de résultats sommaires à ClinicalTrials.gov. Les dossiers d'étude et les résultats rapportés sont examinés par la Bibliothèque nationale de médecine (NLM) pour s'assurer qu'ils répondent à des normes de contrôle de qualité spécifiques avant d'être publiés sur le site Web public.
Dates principales de l'étude
Début de l'étude
1 mai 2005
Achèvement primaire (Réel)
1 septembre 2009
Achèvement de l'étude (Réel)
1 mars 2012
Dates d'inscription aux études
Première soumission
3 mai 2005
Première soumission répondant aux critères de contrôle qualité
3 mai 2005
Première publication (Estimation)
4 mai 2005
Mises à jour des dossiers d'étude
Dernière mise à jour publiée (Estimation)
17 avril 2014
Dernière mise à jour soumise répondant aux critères de contrôle qualité
21 mars 2014
Dernière vérification
1 décembre 2013
Plus d'information
Termes liés à cette étude
Termes MeSH pertinents supplémentaires
- Maladies du système immunitaire
- Tumeurs par type histologique
- Tumeurs
- Troubles lymphoprolifératifs
- Maladies lymphatiques
- Troubles immunoprolifératifs
- Lymphome non hodgkinien
- Lymphome
- Lymphome à cellules du manteau
- Effets physiologiques des médicaments
- Agents anti-infectieux
- Agents antirhumatismaux
- Agents antinéoplasiques
- Agents immunosuppresseurs
- Facteurs immunologiques
- Agents antinéoplasiques immunologiques
- Agents antibactériens
- Antibiotiques, Antinéoplasiques
- Agents antifongiques
- Rituximab
- Sirolimus
Autres numéros d'identification d'étude
- NCI-2009-00644
- U10CA025224 (Subvention/contrat des NIH des États-Unis)
- N038H
- CDR0000425334 (Identificateur de registre: PDQ (Physician Data Query))
Ces informations ont été extraites directement du site Web clinicaltrials.gov sans aucune modification. Si vous avez des demandes de modification, de suppression ou de mise à jour des détails de votre étude, veuillez contacter register@clinicaltrials.gov. Dès qu'un changement est mis en œuvre sur clinicaltrials.gov, il sera également mis à jour automatiquement sur notre site Web .
Essais cliniques sur rituximab
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Children's Oncology GroupNational Cancer Institute (NCI)ComplétéTrouble lymphoprolifératif post-transplantation lié à l'EBV | Trouble lymphoprolifératif post-transplantation monomorphe | Trouble lymphoprolifératif post-transplantation polymorphe | Trouble lymphoprolifératif post-transplantation monomorphe récurrent | Trouble lymphoprolifératif polymorphe... et d'autres conditionsÉtats-Unis
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National Cancer Institute (NCI)ComplétéLymphome folliculaire Ann Arbor Stade III Grade 1 | Ann Arbor Stade III Grade 2 Lymphome folliculaire | Ann Arbor Stade IV Grade 1 Lymphome Folliculaire | Ann Arbor Stade IV Grade 2 Lymphome folliculaire | Ann Arbor Stade II Grade 3 Lymphome folliculaire contigu | Ann Arbor Stade II Grade... et d'autres conditionsÉtats-Unis
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Academic and Community Cancer Research UnitedNational Cancer Institute (NCI)RésiliéLymphome folliculaire de grade 1 récurrent | Lymphome folliculaire de grade 2 récurrent | Lymphome à cellules du manteau récurrent | Lymphome récurrent de la zone marginale | Lymphome non hodgkinien réfractaire à cellules B | Petit lymphome lymphocytaire récurrent | Lymphome non hodgkinien récurrent... et d'autres conditionsÉtats-Unis
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M.D. Anderson Cancer CenterNational Cancer Institute (NCI)Actif, ne recrute pasPetit lymphome lymphocytaire récurrent | Leucémie prolymphocytaire | Leucémie lymphoïde chronique récurrenteÉtats-Unis
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M.D. Anderson Cancer CenterNational Cancer Institute (NCI)Actif, ne recrute pasAnn Arbor stade I Lymphome folliculaire de grade 1 | Ann Arbor Stade I Grade 2 Lymphome Folliculaire | Lymphome folliculaire Ann Arbor Stade II Grade 1 | Lymphome folliculaire Ann Arbor stade II grade 2États-Unis
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Mabion SAParexelRetiréLa polyarthrite rhumatoïde
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National Cancer Institute (NCI)Celgene CorporationActif, ne recrute pasLymphome folliculaire Ann Arbor Stade III Grade 1 | Ann Arbor Stade III Grade 2 Lymphome folliculaire | Ann Arbor Stade IV Grade 1 Lymphome Folliculaire | Ann Arbor Stade IV Grade 2 Lymphome folliculaire | Ann Arbor Stade II Grade 3 Lymphome folliculaire contigu | Ann Arbor Stade II Grade... et d'autres conditionsÉtats-Unis
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M.D. Anderson Cancer CenterNational Cancer Institute (NCI)Actif, ne recrute pasLeucémie lymphoïde chronique/petit lymphome lymphocytaireÉtats-Unis
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M.D. Anderson Cancer CenterActif, ne recrute pasLymphome à cellules du manteauÉtats-Unis
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National Cancer Institute (NCI)Actif, ne recrute pasLymphome à cellules du manteau récurrent | Lymphome non hodgkinien réfractaire à cellules B | Lymphome non hodgkinien récurrent à cellules B | Lymphome à cellules du manteau réfractaireÉtats-Unis