CCI-779 and Rituximab in Treating Patients With Relapsed or Refractory Non-Hodgkin's Lymphoma
21. mars 2014 oppdatert av: 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
Studieoversikt
Status
Fullført
Intervensjon / Behandling
Detaljert 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.
Studietype
Intervensjonell
Registrering (Faktiske)
71
Fase
- Fase 2
Kontakter og plasseringer
Denne delen inneholder kontaktinformasjon for de som utfører studien, og informasjon om hvor denne studien blir utført.
Studiesteder
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Alabama
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Mobile, Alabama, Forente stater, 36607
- Mobile Infirmary Medical Center
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Colorado
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Aurora, Colorado, Forente stater, 80012
- The Medical Center of Aurora
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Boulder, Colorado, Forente stater, 80301
- Boulder Community Hospital
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Colorado Springs, Colorado, Forente stater, 80907
- Penrose-Saint Francis Healthcare
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Denver, Colorado, Forente stater, 80210
- Porter Adventist Hospital
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Denver, Colorado, Forente stater, 80218
- Presbyterian - Saint Lukes Medical Center - Health One
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Denver, Colorado, Forente stater, 80220
- Rose Medical Center
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Denver, Colorado, Forente stater, 80218
- Exempla Saint Joseph Hospital
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Denver, Colorado, Forente stater, 80224-2522
- Colorado Cancer Research Program CCOP
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Denver, Colorado, Forente stater, 80204
- Saint Anthony Central Hospital
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Englewood, Colorado, Forente stater, 80110
- Swedish Medical Center
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Grand Junction, Colorado, Forente stater, 81502
- Saint Mary's Hospital and Regional Medical Center
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Greeley, Colorado, Forente stater, 80631
- North Colorado Medical Center
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Lone Tree, Colorado, Forente stater, 80124
- Sky Ridge Medical Center
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Longmont, Colorado, Forente stater, 80501
- Longmont United Hospital
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Loveland, Colorado, Forente stater, 80539
- McKee Medical Center
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Pueblo, Colorado, Forente stater, 81004
- Saint Mary Corwin Medical Center
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Thornton, Colorado, Forente stater, 80229
- North Suburban Medical Center
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Wheat Ridge, Colorado, Forente stater, 80033
- Exempla Lutheran Medical Center
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Illinois
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Aurora, Illinois, Forente stater, 60504
- Rush - Copley Medical Center
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Bloomington, Illinois, Forente stater, 61701
- Saint Joseph Medical Center
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Canton, Illinois, Forente stater, 61520
- Graham Hospital Association
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Carthage, Illinois, Forente stater, 62321
- Memorial Hospital
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Eureka, Illinois, Forente stater, 61530
- Eureka Hospital
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Galesburg, Illinois, Forente stater, 61401
- Galesburg Cottage Hospital
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Galesburg, Illinois, Forente stater, 61401
- Galesburg Clinic
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Havana, Illinois, Forente stater, 62644
- Mason District Hospital
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Hopedale, Illinois, Forente stater, 61747
- Hopedale Medical Complex - Hospital
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Joliet, Illinois, Forente stater, 60435
- Joliet Oncology-Hematology Associates Limited
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Kewanee, Illinois, Forente stater, 61443
- Kewanee Hospital
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Macomb, Illinois, Forente stater, 61455
- Mcdonough District Hospital
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Normal, Illinois, Forente stater, 61761
- Community Cancer Center Foundation
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Normal, Illinois, Forente stater, 61761
- Bromenn Regional Medical Center
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Ottawa, Illinois, Forente stater, 61350
- Illinois CancerCare-Ottawa Clinic
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Ottawa, Illinois, Forente stater, 61350
- Ottawa Regional Hospital and Healthcare Center
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Pekin, Illinois, Forente stater, 61554
- Pekin Cancer Treatment Center
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Pekin, Illinois, Forente stater, 61554
- Pekin Hospital
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Peoria, Illinois, Forente stater, 61637
- OSF Saint Francis Medical Center
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Peoria, Illinois, Forente stater, 61615
- Illinois CancerCare-Peoria
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Peoria, Illinois, Forente stater, 61614
- Proctor Hospital
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Peoria, Illinois, Forente stater, 61603
- Methodist Medical Center of Illinois
-
Peoria, Illinois, Forente stater, 61615
- Illinois Oncology Research Association CCOP
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Peru, Illinois, Forente stater, 61354
- Illinois Valley Hospital
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Princeton, Illinois, Forente stater, 61356
- Perry Memorial Hospital
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Spring Valley, Illinois, Forente stater, 61362
- Saint Margaret's Hospital
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Urbana, Illinois, Forente stater, 61801
- Carle Clinic-Urbana Main
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Urbana, Illinois, Forente stater, 61801
- Carle Foundation dba Carle Cancer Center
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Indiana
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Beech Grove, Indiana, Forente stater, 46107
- Saint Francis Hospital and Health Centers
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Michigan City, Indiana, Forente stater, 46360
- Saint Anthony Memorial Health Center
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Richmond, Indiana, Forente stater, 47374
- Reid Hospital and Health Care Services
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Iowa
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Ames, Iowa, Forente stater, 50010
- McFarland Clinic
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Cedar Rapids, Iowa, Forente stater, 52403
- Mercy Hospital
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Cedar Rapids, Iowa, Forente stater, 52402
- Saint Luke's Hospital
-
Cedar Rapids, Iowa, Forente stater, 52403
- Cedar Rapids Oncology Association
-
Cedar Rapids, Iowa, Forente stater, 52403
- Oncology Associates
-
Clive, Iowa, Forente stater, 50325
- Medical Oncology and Hematology Associates-West Des Moines
-
Des Moines, Iowa, Forente stater, 50309
- Iowa Methodist Medical Center
-
Des Moines, Iowa, Forente stater, 50314
- Mercy Medical Center - Des Moines
-
Des Moines, Iowa, Forente stater, 50309
- Medical Oncology and Hematology Associates-Des Moines
-
Des Moines, Iowa, Forente stater, 50316
- Iowa Lutheran Hospital
-
Des Moines, Iowa, Forente stater, 50307
- Mercy Capitol
-
Des Moines, Iowa, Forente stater, 50309
- Iowa Oncology Research Association CCOP
-
Des Moines, Iowa, Forente stater, 50314
- Medical Oncology and Hematology Associates
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Mason City, Iowa, Forente stater, 50401
- Mercy Medical Center - North Iowa
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Sioux City, Iowa, Forente stater, 51104
- Saint Luke's Regional Medical Center
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Sioux City, Iowa, Forente stater, 51101-1733
- Siouxland Regional Cancer Center
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Sioux City, Iowa, Forente stater, 51104
- Mercy Medical Center-Sioux City
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Sioux City, Iowa, Forente stater, 51101
- Siouxland Hematology - Oncology Associates
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Kansas
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Anthony, Kansas, Forente stater, 67003
- Hospital District Sixth of Harper County
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Chanute, Kansas, Forente stater, 66720
- Cancer Center of Kansas - Chanute
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Dodge City, Kansas, Forente stater, 67801
- Cancer Center of Kansas - Dodge City
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El Dorado, Kansas, Forente stater, 67042
- Cancer Center of Kansas - El Dorado
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Fort Scott, Kansas, Forente stater, 66701
- Cancer Center of Kansas - Fort Scott
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Independence, Kansas, Forente stater, 67301
- Cancer Center of Kansas-Independence
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Kingman, Kansas, Forente stater, 67068
- Cancer Center of Kansas-Kingman
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Lawrence, Kansas, Forente stater, 66044
- Lawrence Memorial Hospital
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Newton, Kansas, Forente stater, 67114
- Cancer Center of Kansas - Newton
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Parsons, Kansas, Forente stater, 67357
- Cancer Center of Kansas - Parsons
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Pratt, Kansas, Forente stater, 67124
- Cancer Center of Kansas - Pratt
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Salina, Kansas, Forente stater, 67401
- Cancer Center of Kansas - Salina
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Wellington, Kansas, Forente stater, 67152
- Cancer Center of Kansas - Wellington
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Wichita, Kansas, Forente stater, 67208
- Cancer Center of Kansas-Wichita Medical Arts Tower
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Wichita, Kansas, Forente stater, 67208
- Associates In Womens Health
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Wichita, Kansas, Forente stater, 67214
- Cancer Center of Kansas - Main Office
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Wichita, Kansas, Forente stater, 67214
- Via Christi Regional Medical Center
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Wichita, Kansas, Forente stater, 67214
- Wichita CCOP
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Winfield, Kansas, Forente stater, 67156
- Cancer Center of Kansas - Winfield
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Michigan
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Adrian, Michigan, Forente stater, 49221
- Bixby Medical Center
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Adrian, Michigan, Forente stater, 49221
- Hickman Cancer Center
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Ann Arbor, Michigan, Forente stater, 48106-0995
- Saint Joseph Mercy Hospital
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Ann Arbor, Michigan, Forente stater, 48106
- Michigan Cancer Research Consortium Community Clinical Oncology Program
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Dearborn, Michigan, Forente stater, 48123
- Oakwood Hospital
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Detroit, Michigan, Forente stater, 48236
- Saint John Hospital and Medical Center
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Flint, Michigan, Forente stater, 48502
- Hurley Medical Center
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Flint, Michigan, Forente stater, 48532
- Genesys Regional Medical Center
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Jackson, Michigan, Forente stater, 49201
- Allegiance Health
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Lansing, Michigan, Forente stater, 48912
- Sparrow Hospital
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Livonia, Michigan, Forente stater, 48154
- Saint Mary Mercy Hospital
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Monroe, Michigan, Forente stater, 48162
- Mercy Memorial Hospital
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Monroe, Michigan, Forente stater, 48162
- Community Cancer Center of Monroe
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Pontiac, Michigan, Forente stater, 48341-2985
- Saint Joseph Mercy Oakland
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Port Huron, Michigan, Forente stater, 48060
- Saint Joseph Mercy Port Huron
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Saginaw, Michigan, Forente stater, 48601
- Saint Mary's of Michigan
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Warren, Michigan, Forente stater, 48093
- Saint John Macomb-Oakland Hospital
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Minnesota
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Bemidji, Minnesota, Forente stater, 56601
- Merit Care Clinic Bemidji
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Burnsville, Minnesota, Forente stater, 55337
- Fairview Ridges Hospital
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Coon Rapids, Minnesota, Forente stater, 55433
- Mercy Hospital
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Duluth, Minnesota, Forente stater, 55805
- Miller-Dwan Hospital
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Duluth, Minnesota, Forente stater, 55805
- Saint Mary's Medical Center
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Duluth, Minnesota, Forente stater, 55805
- Duluth Clinic CCOP
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Edina, Minnesota, Forente stater, 55435
- Fairview-Southdale Hospital
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Fridley, Minnesota, Forente stater, 55432
- Unity Hospital
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Maplewood, Minnesota, Forente stater, 55109
- Minnesota Oncology Hematology PA-Maplewood
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Minneapolis, Minnesota, Forente stater, 55407
- Abbott-Northwestern Hospital
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Robbinsdale, Minnesota, Forente stater, 55422
- North Memorial Medical Health Center
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Rochester, Minnesota, Forente stater, 55905
- Mayo Clinic
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Saint Louis Park, Minnesota, Forente stater, 55416
- Park Nicollet Clinic - Saint Louis Park
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Saint Louis Park, Minnesota, Forente stater, 55416
- Metro-Minnesota CCOP
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Saint Paul, Minnesota, Forente stater, 55102
- United Hospital
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Shakopee, Minnesota, Forente stater, 55379
- Saint Francis Regional Medical Center
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Waconia, Minnesota, Forente stater, 55387
- Ridgeview Medical Center
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Woodbury, Minnesota, Forente stater, 55125
- Minnesota Oncology and Hematology PA-Woodbury
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Montana
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Billings, Montana, Forente stater, 59101
- Saint Vincent Healthcare
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Billings, Montana, Forente stater, 59101
- Northern Rockies Radiation Oncology Center
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Billings, Montana, Forente stater, 59101
- Montana Cancer Consortium CCOP
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Billings, Montana, Forente stater, 59107-7000
- Billings Clinic
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Billings, Montana, Forente stater, 59107
- Deaconess Medical Center
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Billings, Montana, Forente stater, 59101
- Hematology-Oncology Centers of the Northern Rockies PC
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Bozeman, Montana, Forente stater, 59715
- Bozeman Deaconess Hospital
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Bozeman, Montana, Forente stater, 59715
- Bozeman Deaconess Cancer Center
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Butte, Montana, Forente stater, 59701
- Saint James Community Hospital and Cancer Treatment Center
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Great Falls, Montana, Forente stater, 59405
- Great Falls Clinic
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Great Falls, Montana, Forente stater, 59405
- Berdeaux, Donald MD (UIA Investigator)
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Havre, Montana, Forente stater, 59501
- Northern Montana Hospital
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Helena, Montana, Forente stater, 59601
- Saint Peter's Community Hospital
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Kalispell, Montana, Forente stater, 59901
- Kalispell Regional Medical Center
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Kalispell, Montana, Forente stater, 59901
- Glacier Oncology PLLC
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Kalispell, Montana, Forente stater, 59901
- Kalispell Medical Oncology
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Missoula, Montana, Forente stater, 59802
- Saint Patrick Hospital - Community Hospital
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Missoula, Montana, Forente stater, 59804
- Guardian Oncology and Center for Wellness
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Missoula, Montana, Forente stater, 59801
- Community Medical Hospital
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Missoula, Montana, Forente stater, 59802
- Montana Cancer Specialists
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North Carolina
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Rutherfordton, North Carolina, Forente stater, 28139
- Rutherford Hospital
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North Dakota
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Bismarck, North Dakota, Forente stater, 58501
- Bismarck Cancer Center
-
Bismarck, North Dakota, Forente stater, 58501
- Mid Dakota Clinic
-
Bismarck, North Dakota, Forente stater, 58501
- Saint Alexius Medical Center
-
Bismarck, North Dakota, Forente stater, 58501
- Medcenter One Health Systems
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Fargo, North Dakota, Forente stater, 58122
- MeritCare Medical Group
-
Fargo, North Dakota, Forente stater, 58122
- Meritcare Hospital
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Ohio
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Bowling Green, Ohio, Forente stater, 43402
- Wood County Oncology Center
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Dayton, Ohio, Forente stater, 45406
- Good Samaritan Hospital - Dayton
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Dayton, Ohio, Forente stater, 45409
- Miami Valley Hospital
-
Dayton, Ohio, Forente stater, 45415
- Samaritan North Health Center
-
Dayton, Ohio, Forente stater, 45405
- Grandview Hospital
-
Dayton, Ohio, Forente stater, 45428
- Veteran Affairs Medical Center
-
Dayton, Ohio, Forente stater, 45429
- Dayton CCOP
-
Elyria, Ohio, Forente stater, 44035
- Hematology Oncology Center Incorporated
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Findlay, Ohio, Forente stater, 45840
- Blanchard Valley Hospital
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Franklin, Ohio, Forente stater, 45005-1066
- Atrium Medical Center-Middletown Regional Hospital
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Fremont, Ohio, Forente stater, 43420
- Fremont Memorial Hospital
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Greenville, Ohio, Forente stater, 45331
- Wayne Hospital
-
Kenton, Ohio, Forente stater, 43326
- Cole, Sharon, K. M.D. (UIA Investigator)
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Kettering, Ohio, Forente stater, 45429
- Kettering Medical Center
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Lima, Ohio, Forente stater, 45804
- Lima Memorial Hospital
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Maumee, Ohio, Forente stater, 43537
- Toledo Radiation Oncology at Northwest Ohio Onocolgy Center
-
Maumee, Ohio, Forente stater, 43537-1839
- Northwest Ohio Oncology Center
-
Maumee, Ohio, Forente stater, 43537
- Saint Luke's Hospital
-
Oregon, Ohio, Forente stater, 43616
- Saint Charles Hospital
-
Oregon, Ohio, Forente stater, 43616
- Bayview Oncology Associates
-
Sandusky, Ohio, Forente stater, 44870
- North Coast Cancer Care
-
Sandusky, Ohio, Forente stater, 44870
- Firelands Regional Medical Center
-
Sylvania, Ohio, Forente stater, 43560
- Flower Memorial Hospital
-
Tiffin, Ohio, Forente stater, 44883
- Mercy Hospital of Tiffin
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Toledo, Ohio, Forente stater, 43608
- Saint Vincent Mercy Medical Center
-
Toledo, Ohio, Forente stater, 43614
- University of Toledo
-
Toledo, Ohio, Forente stater, 43617
- Toledo Community Hospital Oncology Program CCOP
-
Toledo, Ohio, Forente stater, 43606
- The Toledo Hospital
-
Toledo, Ohio, Forente stater, 43623
- Toledo Clinic
-
Toledo, Ohio, Forente stater, 43623
- Stark, Michael, Edward. M.D. (UIA Investigator)
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Toledo, Ohio, Forente stater, 43623
- Mercy Cancer Center at Saint Anne Mercy Hospital
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Troy, Ohio, Forente stater, 45373
- Upper Valley Medical Center
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Wauseon, Ohio, Forente stater, 43567
- Fulton County Health Center
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Wilmington, Ohio, Forente stater, 45177
- Clinton Memorial Hospital
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Xenia, Ohio, Forente stater, 45385
- Greene Memorial Hospital
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Pennsylvania
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Allentown, Pennsylvania, Forente stater, 18105
- Lehigh Valley Hospital
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Danville, Pennsylvania, Forente stater, 17822-2001
- Geisinger Medical Center
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State College, Pennsylvania, Forente stater, 16801
- Geisinger Medical Group
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Wilkes-Barre, Pennsylvania, Forente stater, 18711
- Geisinger Wyoming Valley
-
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South Carolina
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Anderson, South Carolina, Forente stater, 29621
- AnMed Health Hospital
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Spartanburg, South Carolina, Forente stater, 29303
- Spartanburg Regional Medical Center
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Spartanburg, South Carolina, Forente stater, 29303
- Upstate Carolina CCOP
-
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South Dakota
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Sioux Falls, South Dakota, Forente stater, 57105
- Avera Cancer Institute
-
Sioux Falls, South Dakota, Forente stater, 57105
- Avera McKennan Hospital and University Health Center
-
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Virginia
-
Fredericksburg, Virginia, Forente stater, 22401
- Fredericksburg Oncology Inc
-
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Wyoming
-
Sheridan, Wyoming, Forente stater, 82801
- Welch Cancer Center
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Deltakelseskriterier
Forskere ser etter personer som passer til en bestemt beskrivelse, kalt kvalifikasjonskriterier. Noen eksempler på disse kriteriene er en persons generelle helsetilstand eller tidligere behandlinger.
Kvalifikasjonskriterier
Alder som er kvalifisert for studier
18 år og eldre (Voksen, Eldre voksen)
Tar imot friske frivillige
Nei
Kjønn som er kvalifisert for studier
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
Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.
Hvordan er studiet utformet?
Designdetaljer
- Primært formål: Behandling
- Tildeling: N/A
- Intervensjonsmodell: Enkeltgruppeoppdrag
- Masking: Ingen (Open Label)
Våpen og intervensjoner
Deltakergruppe / Arm |
Intervensjon / Behandling |
|---|---|
|
Eksperimentell: 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 navn:
25 mg given IV
Andre navn:
|
Hva måler studien?
Primære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
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 |
Tiltaksbeskrivelse |
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.
|
Samarbeidspartnere og etterforskere
Det er her du vil finne personer og organisasjoner som er involvert i denne studien.
Sponsor
Etterforskere
- Hovedetterforsker: Stephen Ansell, North Central Cancer Treatment Group
Publikasjoner og nyttige lenker
Den som er ansvarlig for å legge inn informasjon om studien leverer frivillig disse publikasjonene. Disse kan handle om alt relatert til studiet.
Studierekorddatoer
Disse datoene sporer fremdriften for innsending av studieposter og sammendragsresultater til ClinicalTrials.gov. Studieposter og rapporterte resultater gjennomgås av National Library of Medicine (NLM) for å sikre at de oppfyller spesifikke kvalitetskontrollstandarder før de legges ut på det offentlige nettstedet.
Studer hoveddatoer
Studiestart
1. mai 2005
Primær fullføring (Faktiske)
1. september 2009
Studiet fullført (Faktiske)
1. mars 2012
Datoer for studieregistrering
Først innsendt
3. mai 2005
Først innsendt som oppfylte QC-kriteriene
3. mai 2005
Først lagt ut (Anslag)
4. mai 2005
Oppdateringer av studieposter
Sist oppdatering lagt ut (Anslag)
17. april 2014
Siste oppdatering sendt inn som oppfylte QC-kriteriene
21. mars 2014
Sist bekreftet
1. desember 2013
Mer informasjon
Begreper knyttet til denne studien
Ytterligere relevante MeSH-vilkår
- Sykdommer i immunsystemet
- Neoplasmer etter histologisk type
- Neoplasmer
- Lymfoproliferative lidelser
- Lymfesykdommer
- Immunproliferative lidelser
- Lymfom, Non-Hodgkin
- Lymfom
- Lymfom, mantelcelle
- Fysiologiske effekter av legemidler
- Anti-infeksjonsmidler
- Antirevmatiske midler
- Antineoplastiske midler
- Immunsuppressive midler
- Immunologiske faktorer
- Antineoplastiske midler, immunologiske
- Antibakterielle midler
- Antibiotika, antineoplastisk
- Antifungale midler
- Rituximab
- Sirolimus
Andre studie-ID-numre
- NCI-2009-00644
- U10CA025224 (U.S. NIH-stipend/kontrakt)
- N038H
- CDR0000425334 (Registeridentifikator: PDQ (Physician Data Query))
Denne informasjonen ble hentet direkte fra nettstedet clinicaltrials.gov uten noen endringer. Hvis du har noen forespørsler om å endre, fjerne eller oppdatere studiedetaljene dine, vennligst kontakt register@clinicaltrials.gov. Så snart en endring er implementert på clinicaltrials.gov, vil denne også bli oppdatert automatisk på nettstedet vårt. .
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