CCI-779 and Rituximab in Treating Patients With Relapsed or Refractory Non-Hodgkin's Lymphoma
21 mars 2014 uppdaterad 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
Studieöversikt
Status
Avslutad
Betingelser
Intervention / Behandling
Detaljerad beskrivning
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.
Studietyp
Interventionell
Inskrivning (Faktisk)
71
Fas
- Fas 2
Kontakter och platser
Det här avsnittet innehåller kontaktuppgifter för dem som genomför studien och information om var denna studie genomförs.
Studieorter
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Alabama
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Mobile, Alabama, Förenta staterna, 36607
- Mobile Infirmary Medical Center
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Colorado
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Aurora, Colorado, Förenta staterna, 80012
- The Medical Center of Aurora
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Boulder, Colorado, Förenta staterna, 80301
- Boulder Community Hospital
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Colorado Springs, Colorado, Förenta staterna, 80907
- Penrose-Saint Francis Healthcare
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Denver, Colorado, Förenta staterna, 80210
- Porter Adventist Hospital
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Denver, Colorado, Förenta staterna, 80218
- Presbyterian - Saint Lukes Medical Center - Health One
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Denver, Colorado, Förenta staterna, 80220
- Rose Medical Center
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Denver, Colorado, Förenta staterna, 80218
- Exempla Saint Joseph Hospital
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Denver, Colorado, Förenta staterna, 80224-2522
- Colorado Cancer Research Program CCOP
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Denver, Colorado, Förenta staterna, 80204
- Saint Anthony Central Hospital
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Englewood, Colorado, Förenta staterna, 80110
- Swedish Medical Center
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Grand Junction, Colorado, Förenta staterna, 81502
- Saint Mary's Hospital and Regional Medical Center
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Greeley, Colorado, Förenta staterna, 80631
- North Colorado Medical Center
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Lone Tree, Colorado, Förenta staterna, 80124
- Sky Ridge Medical Center
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Longmont, Colorado, Förenta staterna, 80501
- Longmont United Hospital
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Loveland, Colorado, Förenta staterna, 80539
- McKee Medical Center
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Pueblo, Colorado, Förenta staterna, 81004
- Saint Mary Corwin Medical Center
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Thornton, Colorado, Förenta staterna, 80229
- North Suburban Medical Center
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Wheat Ridge, Colorado, Förenta staterna, 80033
- Exempla Lutheran Medical Center
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Illinois
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Aurora, Illinois, Förenta staterna, 60504
- Rush - Copley Medical Center
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Bloomington, Illinois, Förenta staterna, 61701
- Saint Joseph Medical Center
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Canton, Illinois, Förenta staterna, 61520
- Graham Hospital Association
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Carthage, Illinois, Förenta staterna, 62321
- Memorial Hospital
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Eureka, Illinois, Förenta staterna, 61530
- Eureka Hospital
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Galesburg, Illinois, Förenta staterna, 61401
- Galesburg Cottage Hospital
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Galesburg, Illinois, Förenta staterna, 61401
- Galesburg Clinic
-
Havana, Illinois, Förenta staterna, 62644
- Mason District Hospital
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Hopedale, Illinois, Förenta staterna, 61747
- Hopedale Medical Complex - Hospital
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Joliet, Illinois, Förenta staterna, 60435
- Joliet Oncology-Hematology Associates Limited
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Kewanee, Illinois, Förenta staterna, 61443
- Kewanee Hospital
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Macomb, Illinois, Förenta staterna, 61455
- Mcdonough District Hospital
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Normal, Illinois, Förenta staterna, 61761
- Community Cancer Center Foundation
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Normal, Illinois, Förenta staterna, 61761
- Bromenn Regional Medical Center
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Ottawa, Illinois, Förenta staterna, 61350
- Illinois CancerCare-Ottawa Clinic
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Ottawa, Illinois, Förenta staterna, 61350
- Ottawa Regional Hospital and Healthcare Center
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Pekin, Illinois, Förenta staterna, 61554
- Pekin Cancer Treatment Center
-
Pekin, Illinois, Förenta staterna, 61554
- Pekin Hospital
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Peoria, Illinois, Förenta staterna, 61637
- OSF Saint Francis Medical Center
-
Peoria, Illinois, Förenta staterna, 61615
- Illinois CancerCare-Peoria
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Peoria, Illinois, Förenta staterna, 61614
- Proctor Hospital
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Peoria, Illinois, Förenta staterna, 61603
- Methodist Medical Center of Illinois
-
Peoria, Illinois, Förenta staterna, 61615
- Illinois Oncology Research Association CCOP
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Peru, Illinois, Förenta staterna, 61354
- Illinois Valley Hospital
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Princeton, Illinois, Förenta staterna, 61356
- Perry Memorial Hospital
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Spring Valley, Illinois, Förenta staterna, 61362
- Saint Margaret's Hospital
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Urbana, Illinois, Förenta staterna, 61801
- Carle Clinic-Urbana Main
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Urbana, Illinois, Förenta staterna, 61801
- Carle Foundation dba Carle Cancer Center
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Indiana
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Beech Grove, Indiana, Förenta staterna, 46107
- Saint Francis Hospital and Health Centers
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Michigan City, Indiana, Förenta staterna, 46360
- Saint Anthony Memorial Health Center
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Richmond, Indiana, Förenta staterna, 47374
- Reid Hospital and Health Care Services
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Iowa
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Ames, Iowa, Förenta staterna, 50010
- McFarland Clinic
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Cedar Rapids, Iowa, Förenta staterna, 52403
- Mercy Hospital
-
Cedar Rapids, Iowa, Förenta staterna, 52402
- Saint Luke's Hospital
-
Cedar Rapids, Iowa, Förenta staterna, 52403
- Cedar Rapids Oncology Association
-
Cedar Rapids, Iowa, Förenta staterna, 52403
- Oncology Associates
-
Clive, Iowa, Förenta staterna, 50325
- Medical Oncology and Hematology Associates-West Des Moines
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Des Moines, Iowa, Förenta staterna, 50309
- Iowa Methodist Medical Center
-
Des Moines, Iowa, Förenta staterna, 50314
- Mercy Medical Center - Des Moines
-
Des Moines, Iowa, Förenta staterna, 50309
- Medical Oncology and Hematology Associates-Des Moines
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Des Moines, Iowa, Förenta staterna, 50316
- Iowa Lutheran Hospital
-
Des Moines, Iowa, Förenta staterna, 50307
- Mercy Capitol
-
Des Moines, Iowa, Förenta staterna, 50309
- Iowa Oncology Research Association CCOP
-
Des Moines, Iowa, Förenta staterna, 50314
- Medical Oncology and Hematology Associates
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Mason City, Iowa, Förenta staterna, 50401
- Mercy Medical Center - North Iowa
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Sioux City, Iowa, Förenta staterna, 51104
- Saint Luke's Regional Medical Center
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Sioux City, Iowa, Förenta staterna, 51101-1733
- Siouxland Regional Cancer Center
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Sioux City, Iowa, Förenta staterna, 51104
- Mercy Medical Center-Sioux City
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Sioux City, Iowa, Förenta staterna, 51101
- Siouxland Hematology - Oncology Associates
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Kansas
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Anthony, Kansas, Förenta staterna, 67003
- Hospital District Sixth of Harper County
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Chanute, Kansas, Förenta staterna, 66720
- Cancer Center of Kansas - Chanute
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Dodge City, Kansas, Förenta staterna, 67801
- Cancer Center of Kansas - Dodge City
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El Dorado, Kansas, Förenta staterna, 67042
- Cancer Center of Kansas - El Dorado
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Fort Scott, Kansas, Förenta staterna, 66701
- Cancer Center of Kansas - Fort Scott
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Independence, Kansas, Förenta staterna, 67301
- Cancer Center of Kansas-Independence
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Kingman, Kansas, Förenta staterna, 67068
- Cancer Center of Kansas-Kingman
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Lawrence, Kansas, Förenta staterna, 66044
- Lawrence Memorial Hospital
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Newton, Kansas, Förenta staterna, 67114
- Cancer Center of Kansas - Newton
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Parsons, Kansas, Förenta staterna, 67357
- Cancer Center of Kansas - Parsons
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Pratt, Kansas, Förenta staterna, 67124
- Cancer Center of Kansas - Pratt
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Salina, Kansas, Förenta staterna, 67401
- Cancer Center of Kansas - Salina
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Wellington, Kansas, Förenta staterna, 67152
- Cancer Center of Kansas - Wellington
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Wichita, Kansas, Förenta staterna, 67208
- Cancer Center of Kansas-Wichita Medical Arts Tower
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Wichita, Kansas, Förenta staterna, 67208
- Associates In Womens Health
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Wichita, Kansas, Förenta staterna, 67214
- Cancer Center of Kansas - Main Office
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Wichita, Kansas, Förenta staterna, 67214
- Via Christi Regional Medical Center
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Wichita, Kansas, Förenta staterna, 67214
- Wichita CCOP
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Winfield, Kansas, Förenta staterna, 67156
- Cancer Center of Kansas - Winfield
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Michigan
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Adrian, Michigan, Förenta staterna, 49221
- Bixby Medical Center
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Adrian, Michigan, Förenta staterna, 49221
- Hickman Cancer Center
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Ann Arbor, Michigan, Förenta staterna, 48106-0995
- Saint Joseph Mercy Hospital
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Ann Arbor, Michigan, Förenta staterna, 48106
- Michigan Cancer Research Consortium Community Clinical Oncology Program
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Dearborn, Michigan, Förenta staterna, 48123
- Oakwood Hospital
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Detroit, Michigan, Förenta staterna, 48236
- Saint John Hospital and Medical Center
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Flint, Michigan, Förenta staterna, 48502
- Hurley Medical Center
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Flint, Michigan, Förenta staterna, 48532
- Genesys Regional Medical Center
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Jackson, Michigan, Förenta staterna, 49201
- Allegiance Health
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Lansing, Michigan, Förenta staterna, 48912
- Sparrow Hospital
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Livonia, Michigan, Förenta staterna, 48154
- Saint Mary Mercy Hospital
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Monroe, Michigan, Förenta staterna, 48162
- Mercy Memorial Hospital
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Monroe, Michigan, Förenta staterna, 48162
- Community Cancer Center of Monroe
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Pontiac, Michigan, Förenta staterna, 48341-2985
- Saint Joseph Mercy Oakland
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Port Huron, Michigan, Förenta staterna, 48060
- Saint Joseph Mercy Port Huron
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Saginaw, Michigan, Förenta staterna, 48601
- Saint Mary's of Michigan
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Warren, Michigan, Förenta staterna, 48093
- Saint John Macomb-Oakland Hospital
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Minnesota
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Bemidji, Minnesota, Förenta staterna, 56601
- Merit Care Clinic Bemidji
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Burnsville, Minnesota, Förenta staterna, 55337
- Fairview Ridges Hospital
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Coon Rapids, Minnesota, Förenta staterna, 55433
- Mercy Hospital
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Duluth, Minnesota, Förenta staterna, 55805
- Miller-Dwan Hospital
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Duluth, Minnesota, Förenta staterna, 55805
- Saint Mary's Medical Center
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Duluth, Minnesota, Förenta staterna, 55805
- Duluth Clinic CCOP
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Edina, Minnesota, Förenta staterna, 55435
- Fairview-Southdale Hospital
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Fridley, Minnesota, Förenta staterna, 55432
- Unity Hospital
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Maplewood, Minnesota, Förenta staterna, 55109
- Minnesota Oncology Hematology PA-Maplewood
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Minneapolis, Minnesota, Förenta staterna, 55407
- Abbott-Northwestern Hospital
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Robbinsdale, Minnesota, Förenta staterna, 55422
- North Memorial Medical Health Center
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Rochester, Minnesota, Förenta staterna, 55905
- Mayo Clinic
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Saint Louis Park, Minnesota, Förenta staterna, 55416
- Park Nicollet Clinic - Saint Louis Park
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Saint Louis Park, Minnesota, Förenta staterna, 55416
- Metro-Minnesota CCOP
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Saint Paul, Minnesota, Förenta staterna, 55102
- United Hospital
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Shakopee, Minnesota, Förenta staterna, 55379
- Saint Francis Regional Medical Center
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Waconia, Minnesota, Förenta staterna, 55387
- Ridgeview Medical Center
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Woodbury, Minnesota, Förenta staterna, 55125
- Minnesota Oncology and Hematology PA-Woodbury
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Montana
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Billings, Montana, Förenta staterna, 59101
- Saint Vincent Healthcare
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Billings, Montana, Förenta staterna, 59101
- Northern Rockies Radiation Oncology Center
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Billings, Montana, Förenta staterna, 59101
- Montana Cancer Consortium CCOP
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Billings, Montana, Förenta staterna, 59107-7000
- Billings Clinic
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Billings, Montana, Förenta staterna, 59107
- Deaconess Medical Center
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Billings, Montana, Förenta staterna, 59101
- Hematology-Oncology Centers of the Northern Rockies PC
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Bozeman, Montana, Förenta staterna, 59715
- Bozeman Deaconess Hospital
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Bozeman, Montana, Förenta staterna, 59715
- Bozeman Deaconess Cancer Center
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Butte, Montana, Förenta staterna, 59701
- Saint James Community Hospital and Cancer Treatment Center
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Great Falls, Montana, Förenta staterna, 59405
- Great Falls Clinic
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Great Falls, Montana, Förenta staterna, 59405
- Berdeaux, Donald MD (UIA Investigator)
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Havre, Montana, Förenta staterna, 59501
- Northern Montana Hospital
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Helena, Montana, Förenta staterna, 59601
- Saint Peter's Community Hospital
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Kalispell, Montana, Förenta staterna, 59901
- Kalispell Regional Medical Center
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Kalispell, Montana, Förenta staterna, 59901
- Glacier Oncology PLLC
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Kalispell, Montana, Förenta staterna, 59901
- Kalispell Medical Oncology
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Missoula, Montana, Förenta staterna, 59802
- Saint Patrick Hospital - Community Hospital
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Missoula, Montana, Förenta staterna, 59804
- Guardian Oncology and Center for Wellness
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Missoula, Montana, Förenta staterna, 59801
- Community Medical Hospital
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Missoula, Montana, Förenta staterna, 59802
- Montana Cancer Specialists
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North Carolina
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Rutherfordton, North Carolina, Förenta staterna, 28139
- Rutherford Hospital
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North Dakota
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Bismarck, North Dakota, Förenta staterna, 58501
- Bismarck Cancer Center
-
Bismarck, North Dakota, Förenta staterna, 58501
- Mid Dakota Clinic
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Bismarck, North Dakota, Förenta staterna, 58501
- Saint Alexius Medical Center
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Bismarck, North Dakota, Förenta staterna, 58501
- Medcenter One Health Systems
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Fargo, North Dakota, Förenta staterna, 58122
- MeritCare Medical Group
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Fargo, North Dakota, Förenta staterna, 58122
- Meritcare Hospital
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Ohio
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Bowling Green, Ohio, Förenta staterna, 43402
- Wood County Oncology Center
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Dayton, Ohio, Förenta staterna, 45406
- Good Samaritan Hospital - Dayton
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Dayton, Ohio, Förenta staterna, 45409
- Miami Valley Hospital
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Dayton, Ohio, Förenta staterna, 45415
- Samaritan North Health Center
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Dayton, Ohio, Förenta staterna, 45405
- Grandview Hospital
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Dayton, Ohio, Förenta staterna, 45428
- Veteran Affairs Medical Center
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Dayton, Ohio, Förenta staterna, 45429
- Dayton CCOP
-
Elyria, Ohio, Förenta staterna, 44035
- Hematology Oncology Center Incorporated
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Findlay, Ohio, Förenta staterna, 45840
- Blanchard Valley Hospital
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Franklin, Ohio, Förenta staterna, 45005-1066
- Atrium Medical Center-Middletown Regional Hospital
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Fremont, Ohio, Förenta staterna, 43420
- Fremont Memorial Hospital
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Greenville, Ohio, Förenta staterna, 45331
- Wayne Hospital
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Kenton, Ohio, Förenta staterna, 43326
- Cole, Sharon, K. M.D. (UIA Investigator)
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Kettering, Ohio, Förenta staterna, 45429
- Kettering Medical Center
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Lima, Ohio, Förenta staterna, 45804
- Lima Memorial Hospital
-
Maumee, Ohio, Förenta staterna, 43537
- Toledo Radiation Oncology at Northwest Ohio Onocolgy Center
-
Maumee, Ohio, Förenta staterna, 43537-1839
- Northwest Ohio Oncology Center
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Maumee, Ohio, Förenta staterna, 43537
- Saint Luke's Hospital
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Oregon, Ohio, Förenta staterna, 43616
- Saint Charles Hospital
-
Oregon, Ohio, Förenta staterna, 43616
- Bayview Oncology Associates
-
Sandusky, Ohio, Förenta staterna, 44870
- North Coast Cancer Care
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Sandusky, Ohio, Förenta staterna, 44870
- Firelands Regional Medical Center
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Sylvania, Ohio, Förenta staterna, 43560
- Flower Memorial Hospital
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Tiffin, Ohio, Förenta staterna, 44883
- Mercy Hospital of Tiffin
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Toledo, Ohio, Förenta staterna, 43608
- Saint Vincent Mercy Medical Center
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Toledo, Ohio, Förenta staterna, 43614
- University of Toledo
-
Toledo, Ohio, Förenta staterna, 43617
- Toledo Community Hospital Oncology Program CCOP
-
Toledo, Ohio, Förenta staterna, 43606
- The Toledo Hospital
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Toledo, Ohio, Förenta staterna, 43623
- Toledo Clinic
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Toledo, Ohio, Förenta staterna, 43623
- Stark, Michael, Edward. M.D. (UIA Investigator)
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Toledo, Ohio, Förenta staterna, 43623
- Mercy Cancer Center at Saint Anne Mercy Hospital
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Troy, Ohio, Förenta staterna, 45373
- Upper Valley Medical Center
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Wauseon, Ohio, Förenta staterna, 43567
- Fulton County Health Center
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Wilmington, Ohio, Förenta staterna, 45177
- Clinton Memorial Hospital
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Xenia, Ohio, Förenta staterna, 45385
- Greene Memorial Hospital
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Pennsylvania
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Allentown, Pennsylvania, Förenta staterna, 18105
- Lehigh Valley Hospital
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Danville, Pennsylvania, Förenta staterna, 17822-2001
- Geisinger Medical Center
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State College, Pennsylvania, Förenta staterna, 16801
- Geisinger Medical Group
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Wilkes-Barre, Pennsylvania, Förenta staterna, 18711
- Geisinger Wyoming Valley
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South Carolina
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Anderson, South Carolina, Förenta staterna, 29621
- AnMed Health Hospital
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Spartanburg, South Carolina, Förenta staterna, 29303
- Spartanburg Regional Medical Center
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Spartanburg, South Carolina, Förenta staterna, 29303
- Upstate Carolina CCOP
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South Dakota
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Sioux Falls, South Dakota, Förenta staterna, 57105
- Avera Cancer Institute
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Sioux Falls, South Dakota, Förenta staterna, 57105
- Avera McKennan Hospital and University Health Center
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Virginia
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Fredericksburg, Virginia, Förenta staterna, 22401
- Fredericksburg Oncology Inc
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Wyoming
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Sheridan, Wyoming, Förenta staterna, 82801
- Welch Cancer Center
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Deltagandekriterier
Forskare letar efter personer som passar en viss beskrivning, så kallade behörighetskriterier. Några exempel på dessa kriterier är en persons allmänna hälsotillstånd eller tidigare behandlingar.
Urvalskriterier
Åldrar som är berättigade till studier
18 år och äldre (Vuxen, Äldre vuxen)
Tar emot friska volontärer
Nej
Kön som är behöriga för studier
Allt
Beskrivning
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
Det här avsnittet ger detaljer om studieplanen, inklusive hur studien är utformad och vad studien mäter.
Hur är studien utformad?
Designdetaljer
- Primärt syfte: Behandling
- Tilldelning: N/A
- Interventionsmodell: Enskild gruppuppgift
- Maskning: Ingen (Open Label)
Vapen och interventioner
Deltagargrupp / Arm |
Intervention / Behandling |
|---|---|
|
Experimentell: 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
Andra namn:
25 mg given IV
Andra namn:
|
Vad mäter studien?
Primära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
|
Overall Response Rate (Complete and Partial Responses) as Defined by the International Workshop Criteria
Tidsram: 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.
|
Sekundära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
|
Time to Progression
Tidsram: 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
Tidsram: 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.
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Response duration is followed up to 5 years from registration.
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Toxicity
Tidsram: Assessed during treatment (up to 12, 28-day cycles)
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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)
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Overall Survival
Tidsram: Patients were followed for survival status for up to 5 years.
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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.
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Patients were followed for survival status for up to 5 years.
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Samarbetspartners och utredare
Det är här du hittar personer och organisationer som är involverade i denna studie.
Sponsor
Utredare
- Huvudutredare: Stephen Ansell, North Central Cancer Treatment Group
Publikationer och användbara länkar
Den som ansvarar för att lägga in information om studien tillhandahåller frivilligt dessa publikationer. Dessa kan handla om allt som har med studien att göra.
Studieavstämningsdatum
Dessa datum spårar framstegen för inlämningar av studieposter och sammanfattande resultat till ClinicalTrials.gov. Studieposter och rapporterade resultat granskas av National Library of Medicine (NLM) för att säkerställa att de uppfyller specifika kvalitetskontrollstandarder innan de publiceras på den offentliga webbplatsen.
Studera stora datum
Studiestart
1 maj 2005
Primärt slutförande (Faktisk)
1 september 2009
Avslutad studie (Faktisk)
1 mars 2012
Studieregistreringsdatum
Först inskickad
3 maj 2005
Först inskickad som uppfyllde QC-kriterierna
3 maj 2005
Första postat (Uppskatta)
4 maj 2005
Uppdateringar av studier
Senaste uppdatering publicerad (Uppskatta)
17 april 2014
Senaste inskickade uppdateringen som uppfyllde QC-kriterierna
21 mars 2014
Senast verifierad
1 december 2013
Mer information
Termer relaterade till denna studie
Ytterligare relevanta MeSH-villkor
- Immunsystemets sjukdomar
- Neoplasmer efter histologisk typ
- Neoplasmer
- Lymfoproliferativa störningar
- Lymfatiska sjukdomar
- Immunproliferativa störningar
- Lymfom, icke-Hodgkin
- Lymfom
- Lymfom, mantelcell
- Läkemedels fysiologiska effekter
- Anti-infektionsmedel
- Antireumatiska medel
- Antineoplastiska medel
- Immunsuppressiva medel
- Immunologiska faktorer
- Antineoplastiska medel, immunologiska
- Antibakteriella medel
- Antibiotika, antineoplastiska
- Antifungala medel
- Rituximab
- Sirolimus
Andra studie-ID-nummer
- NCI-2009-00644
- U10CA025224 (U.S.S. NIH-anslag/kontrakt)
- N038H
- CDR0000425334 (Registeridentifierare: PDQ (Physician Data Query))
Denna information hämtades direkt från webbplatsen clinicaltrials.gov utan några ändringar. Om du har några önskemål om att ändra, ta bort eller uppdatera dina studieuppgifter, vänligen kontakta register@clinicaltrials.gov. Så snart en ändring har implementerats på clinicaltrials.gov, kommer denna att uppdateras automatiskt även på vår webbplats .
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