Monoclonal Antibody Therapy and Combination Chemotherapy in Treating Patients With Stage II, Stage III, or Stage IV Diffuse Large B-Cell Lymphoma
1. oktober 2019 oppdatert av: Alliance for Clinical Trials in Oncology
A Phase II Study of Epratuzumab, Rituximab (ER)-CHOP for Patients With Previously Untreated Diffuse Large B-Cell Lymphoma
RATIONALE: Monoclonal antibodies, such as epratuzumab and 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.
Drugs used in chemotherapy, such as cyclophosphamide, doxorubicin, vincristine, and prednisone, work in different ways to stop the growth of cancer cells, either by killing the cells or by stopping them from dividing.
Giving monoclonal antibody therapy together with chemotherapy may kill more cancer cells.>
PURPOSE: This phase II trial is studying how well giving monoclonal antibody therapy together with combination chemotherapy works in treating patients with stage II, stage III, or stage IV diffuse large B-cell lymphoma.
Studieoversikt
Status
Fullført
Forhold
Detaljert beskrivelse
OBJECTIVES:> Primary>
- Assess the efficacy of epratuzumab and rituximab in combination with cyclophosphamide, doxorubicin hydrochloride, vincristine, and prednisone (CHOP), as measured by 12-month, event-free survival, in patients with previously untreated stage II, III, or IV diffuse large B-cell lymphoma.>
- Assess the use of positron emission tomography (PET) scan routinely early in treatment and after completion of treatment.>
- Assess the functional response rate (complete response, partial response, or stable disease by CT scan and PET negative) in patients treated with this regimen.>
- Assess the safety of this treatment regimen.> Secondary>
- Correlate laboratory prognostic factors for large cell lymphoma with clinical response to this regimen.> OUTLINE: This is a multicenter study.> Patients receive epratuzumab IV over 1 hour on day 1, rituximab IV over 4-8 hours on day 1 or days 1 and 2, cyclophosphamide IV, doxorubicin hydrochloride IV, and vincristine IV on day 1 or 2, and oral prednisone on days 1-5 or 2-6. Treatment repeats every 21 days for up to 6 courses in the absence of disease progression or unacceptable toxicity.> After completion of study treatment, patients are followed periodically for up to 5 years.> PROJECTED ACCRUAL: A total of 86 patients will be accrued for this study.>
Studietype
Intervensjonell
Registrering (Faktiske)
107
Fase
- Fase 2
Kontakter og plasseringer
Denne delen inneholder kontaktinformasjon for de som utfører studien, og informasjon om hvor denne studien blir utført.
Studiesteder
-
-
Arizona
-
Scottsdale, Arizona, Forente stater, 85259-5499
- Mayo Clinic Scottsdale
-
-
Colorado
-
Aurora, Colorado, Forente stater, 80012
- Aurora Presbyterian Hospital
-
Boulder, Colorado, Forente stater, 80301-9019
- Boulder Community Hospital
-
Colorado Springs, Colorado, Forente stater, 80933
- Penrose Cancer Center at Penrose Hospital
-
Denver, Colorado, Forente stater, 80210
- Porter Adventist Hospital
-
Denver, Colorado, Forente stater, 80220
- Rose Medical Center
-
Denver, Colorado, Forente stater, 80218
- Presbyterian - St. Luke's Medical Center
-
Denver, Colorado, Forente stater, 80218
- St. Joseph Hospital
-
Denver, Colorado, Forente stater, 80224-2522
- CCOP - Colorado Cancer Research Program
-
Englewood, Colorado, Forente stater, 80110
- Swedish Medical Center
-
Fort Collins, Colorado, Forente stater, 80524
- Front Range Cancer Specialists
-
Grand Junction, Colorado, Forente stater, 81502
- St. Mary's Regional Cancer Center at St. Mary's Hospital and Medical Center
-
Lone Tree, Colorado, Forente stater, 80124
- Sky Ridge Medical Center
-
Longmont, Colorado, Forente stater, 80502
- Hope Cancer Care Center at Longmont United Hospital
-
Pueblo, Colorado, Forente stater, 81004
- St. Mary - Corwin Regional Medical Center
-
Thornton, Colorado, Forente stater, 80229
- North Suburban Medical Center
-
Wheat Ridge, Colorado, Forente stater, 80033
- Exempla Lutheran Medical Center
-
-
Florida
-
Jacksonville, Florida, Forente stater, 32224
- Mayo Clinic - Jacksonville
-
-
Illinois
-
Aurora, Illinois, Forente stater, 60507
- Rush-Copley Cancer Care Center
-
Bloomington, Illinois, Forente stater, 61701
- St. Joseph Medical Center
-
Canton, Illinois, Forente stater, 61520
- Graham Hospital
-
Carthage, Illinois, Forente stater, 62321
- Memorial Hospital
-
Eureka, Illinois, Forente stater, 61530
- Eureka Community Hospital
-
Galesburg, Illinois, Forente stater, 61401
- Galesburg Cottage Hospital
-
Galesburg, Illinois, Forente stater, 61401
- Galesburg Clinic
-
Havana, Illinois, Forente stater, 62644
- Mason District Hospital
-
Hopedale, Illinois, Forente stater, 61747
- Hopedale Medical Complex
-
Joliet, Illinois, Forente stater, 60435
- Joliet Oncology-Hematology Associates, Limited - West
-
Kewanee, Illinois, Forente stater, 61443
- Kewanee Hospital
-
Macomb, Illinois, Forente stater, 61455
- Mcdonough District Hospital
-
Moline, Illinois, Forente stater, 61265
-
Moline, Illinois, Forente stater, 61265
- Trinity Medical Center - East
-
Normal, Illinois, Forente stater, 61761
- Bromenn Regional Medical Center
-
Normal, Illinois, Forente stater, 61761
- Community Cancer Center
-
Ottawa, Illinois, Forente stater, 61350
- Community Hospital of Ottawa
-
Ottawa, Illinois, Forente stater, 61350
- Oncology Hematology Associates of Central Illinois, PC - Ottawa
-
Pekin, Illinois, Forente stater, 61554
- Cancer Treatment Center at Pekin Hospital
-
Peoria, Illinois, Forente stater, 61636
- Methodist Medical Center of Illinois
-
Peoria, Illinois, Forente stater, 61614
- Proctor Hospital
-
Peoria, Illinois, Forente stater, 61637
- OSF St. Francis Medical Center
-
Peoria, Illinois, Forente stater, 61615
- CCOP - Illinois Oncology Research Association
-
Peoria, Illinois, Forente stater, 61615
- Oncology Hematology Associates of Central Illinois, PC - Peoria
-
Peru, Illinois, Forente stater, 61354
- Illinois Valley Community Hospital
-
Princeton, Illinois, Forente stater, 61356
- Perry Memorial Hospital
-
Spring Valley, Illinois, Forente stater, 61362
- St. Margaret's Hospital
-
Urbana, Illinois, Forente stater, 61801
- Carle Cancer Center at Carle Foundation Hospital
-
Urbana, Illinois, Forente stater, 61801
- CCOP - Carle Cancer Center
-
-
Indiana
-
Beech Grove, Indiana, Forente stater, 46107
- St. Francis Hospital and Health Centers - Beech Grove Campus
-
Michigan City, Indiana, Forente stater, 46360
- Saint Anthony Memorial Health Centers
-
Richmond, Indiana, Forente stater, 47374
- Reid Hospital & Health Care Services, Incorporated
-
-
Iowa
-
Ames, Iowa, Forente stater, 50010
- McFarland Clinic, PC
-
Des Moines, Iowa, Forente stater, 50309
- CCOP - Iowa Oncology Research Association
-
Des Moines, Iowa, Forente stater, 50309
- John Stoddard Cancer Center at Iowa Methodist Medical Center
-
Des Moines, Iowa, Forente stater, 50309
- Medical Oncology and Hematology Associates at John Stoddard Cancer Center
-
Des Moines, Iowa, Forente stater, 50314
- Medical Oncology and Hematology Associates at Mercy Cancer Center
-
Des Moines, Iowa, Forente stater, 50314
- Mercy Cancer Center at Mercy Medical Center - Des Moines
-
Des Moines, Iowa, Forente stater, 50307
- Mercy Capitol Hospital
-
Des Moines, Iowa, Forente stater, 50316-2301
- John Stoddard Cancer Center
-
Mason City, Iowa, Forente stater, 50401
- Mercy Cancer Center at Mercy Medical Center - North Iowa
-
Sioux City, Iowa, Forente stater, 51101
- Siouxland Hematology-Oncology Associates, LLP
-
Sioux City, Iowa, Forente stater, 51104
- St. Luke's Regional Medical Center
-
Sioux City, Iowa, Forente stater, 51104
- Mercy Medical Center - Sioux City
-
-
Kansas
-
Chanute, Kansas, Forente stater, 66720
- Cancer Center of Kansas, PA - Chanute
-
Dodge City, Kansas, Forente stater, 67801
- Cancer Center of Kansas, PA - Dodge City
-
El Dorado, Kansas, Forente stater, 67042
- Cancer Center of Kansas, PA - El Dorado
-
Kingman, Kansas, Forente stater, 67068
- Cancer Center of Kansas, PA - Kingman
-
Liberal, Kansas, Forente stater, 67901
- Southwest Medical Center
-
Newton, Kansas, Forente stater, 67114
- Cancer Center of Kansas, PA - Newton
-
Parsons, Kansas, Forente stater, 67357
- Cancer Center of Kansas, PA - Parsons
-
Pratt, Kansas, Forente stater, 67124
- Cancer Center of Kansas, PA - Pratt
-
Salina, Kansas, Forente stater, 67042
- Cancer Center of Kansas, PA - Salina
-
Wellington, Kansas, Forente stater, 67152
- Cancer Center of Kansas, PA - Wellington
-
Wichita, Kansas, Forente stater, 67203
- Associates in Womens Health, PA - North Review
-
Wichita, Kansas, Forente stater, 67208
- Cancer Center of Kansas, PA - Medical Arts Tower
-
Wichita, Kansas, Forente stater, 67214
- Cancer Center of Kansas, PA - Wichita
-
Wichita, Kansas, Forente stater, 67214
- CCOP - Wichita
-
Wichita, Kansas, Forente stater, 67214
- Via Christi Cancer Center at Via Christi Regional Medical Center
-
Winfield, Kansas, Forente stater, 67156
- Cancer Center of Kansas, PA - Winfield
-
-
Michigan
-
Adrian, Michigan, Forente stater, 49221
- Hickman Cancer Center at Bixby Medical Center
-
Lambertville, Michigan, Forente stater, 48144
- Haematology-Oncology Associates of Ohio and Michigan, PC
-
Monroe, Michigan, Forente stater, 48162
- Community Cancer Center of Monroe
-
Monroe, Michigan, Forente stater, 48162
- Mercy Memorial Hospital - Monroe
-
-
Minnesota
-
Alexandria, Minnesota, Forente stater, 56308
-
Bemidji, Minnesota, Forente stater, 56601
- MeritCare Bemidji
-
Burnsville, Minnesota, Forente stater, 55337
- Fairview Ridges Hospital
-
Coon Rapids, Minnesota, Forente stater, 55433
- Mercy and Unity Cancer Center at Mercy Hospital
-
Duluth, Minnesota, Forente stater, 55805
- CCOP - Duluth
-
Duluth, Minnesota, Forente stater, 55805-1983
- Duluth Clinic Cancer Center - Duluth
-
Duluth, Minnesota, Forente stater, 55805
- Miller - Dwan Medical Center
-
Edina, Minnesota, Forente stater, 55435
- Fairview Southdale Hospital
-
Fergus Falls, Minnesota, Forente stater, 56537
-
Fridley, Minnesota, Forente stater, 55432
- Mercy and Unity Cancer Center at Unity Hospital
-
Hutchinson, Minnesota, Forente stater, 55350
- Hutchinson Area Health Care
-
Litchfield, Minnesota, Forente stater, 55355
- Meeker County Memorial Hospital
-
Maplewood, Minnesota, Forente stater, 55109
- Minnesota Oncology Hematology, PA - Maplewood
-
Maplewood, Minnesota, Forente stater, 55109
- HealthEast Cancer Care at St. John's Hospital
-
Minneapolis, Minnesota, Forente stater, 55407
- Virginia Piper Cancer Institute at Abbott - Northwestern Hospital
-
Minneapolis, Minnesota, Forente stater, 55415
- Hennepin County Medical Center - Minneapolis
-
Montevideo, Minnesota, Forente stater, 56265
- Chippewa County - Montevideo Hospital and Medical Center
-
Robbinsdale, Minnesota, Forente stater, 55422-2900
- Hubert H. Humphrey Cancer Center at North Memorial Outpatient Center
-
Rochester, Minnesota, Forente stater, 55905
- Mayo Clinic Cancer Center
-
Saint Cloud, Minnesota, Forente stater, 56303
- CentraCare Clinic - River Campus
-
Saint Cloud, Minnesota, Forente stater, 56303
- Coborn Cancer Center
-
Saint Louis Park, Minnesota, Forente stater, 55416
- CCOP - Metro-Minnesota
-
Saint Louis Park, Minnesota, Forente stater, 55416
- Park Nicollet Cancer Center
-
Saint Paul, Minnesota, Forente stater, 55102
- United Hospital
-
Saint Paul, Minnesota, Forente stater, 55101
- Regions Hospital Cancer Care Center
-
Saint Paul, Minnesota, Forente stater, 55102
- HealthEast Cancer Care at St. Joseph's Hospital
-
Shakopee, Minnesota, Forente stater, 55379
- St. Francis Cancer Center at St. Francis Medical Center
-
Waconia, Minnesota, Forente stater, 55387
- Ridgeview Medical Center
-
Woodbury, Minnesota, Forente stater, 55125
- Minnesota Oncology Hematology, PA - Woodbury
-
Woodbury, Minnesota, Forente stater, 55125
- HealthEast Cancer Care at Woodwinds Health Campus
-
-
Nebraska
-
Lincoln, Nebraska, Forente stater, 68510
- Cancer Resource Center - Lincoln
-
Omaha, Nebraska, Forente stater, 68106
- CCOP - Missouri Valley Cancer Consortium
-
Omaha, Nebraska, Forente stater, 68122
- Immanuel Medical Center
-
Omaha, Nebraska, Forente stater, 68124
- Alegant Health Cancer Center at Bergan Mercy Medical Center
-
Omaha, Nebraska, Forente stater, 68131-2197
- Creighton University Medical Center
-
-
North Carolina
-
Rutherfordton, North Carolina, Forente stater, 28139
- Rutherford Hospital
-
-
North Dakota
-
Bismarck, North Dakota, Forente stater, 58501
- Bismarck Cancer Center
-
Bismarck, North Dakota, Forente stater, 58501
- Medcenter One Hospital Cancer Care Center
-
Bismarck, North Dakota, Forente stater, 58501
- Mid Dakota Clinic, PC
-
Bismarck, North Dakota, Forente stater, 58502
- St. Alexius Medical Center Cancer Center
-
Fargo, North Dakota, Forente stater, 58122
- CCOP - MeritCare Hospital
-
Fargo, North Dakota, Forente stater, 58122
- MeritCare Broadway
-
-
Ohio
-
Bowling Green, Ohio, Forente stater, 43402
- Wood County Oncology Center
-
Dayton, Ohio, Forente stater, 45428
- Veterans Affairs Medical Center - Dayton
-
Dayton, Ohio, Forente stater, 45405
- Grandview Hospital
-
Dayton, Ohio, Forente stater, 45406
- Good Samaritan Hospital
-
Dayton, Ohio, Forente stater, 45409
- David L. Rike Cancer Center at Miami Valley Hospital
-
Dayton, Ohio, Forente stater, 45415
- Samaritan North Cancer Care Center
-
Dayton, Ohio, Forente stater, 45429
- CCOP - Dayton
-
Findlay, Ohio, Forente stater, 45840
- Blanchard Valley Medical Associates
-
Fremont, Ohio, Forente stater, 43420
- Fremont Memorial Hospital
-
Kettering, Ohio, Forente stater, 45429
- Charles F. Kettering Memorial Hospital
-
Lima, Ohio, Forente stater, 45804
- Lima Memorial Hospital
-
Maumee, Ohio, Forente stater, 43537
- Northwest Ohio Oncology Center
-
Maumee, Ohio, Forente stater, 43537
- St. Luke's Hospital
-
Middletown, Ohio, Forente stater, 45044
- Middletown Regional Hospital
-
Oregon, Ohio, Forente stater, 43616
- St. Charles Mercy Hospital
-
Oregon, Ohio, Forente stater, 43616
- Toledo Clinic - Oregon
-
Sandusky, Ohio, Forente stater, 44870
- Firelands Regional Medical Center
-
Sandusky, Ohio, Forente stater, 44870
- North Coast Cancer Care, Incorporated
-
Sylvania, Ohio, Forente stater, 43560
- Flower Hospital Cancer Center
-
Tiffin, Ohio, Forente stater, 44883
- Mercy Hospital of Tiffin
-
Toledo, Ohio, Forente stater, 43608
- St. Vincent Mercy Medical Center
-
Toledo, Ohio, Forente stater, 43606
- Toledo Hospital
-
Toledo, Ohio, Forente stater, 43614
- Medical University of Ohio Cancer Center
-
Toledo, Ohio, Forente stater, 43617
- CCOP - Toledo Community Hospital
-
Toledo, Ohio, Forente stater, 43623
- Toledo Clinic, Incorporated - Main Clinic
-
Troy, Ohio, Forente stater, 45373-1300
- UVMC Cancer Care Center at Upper Valley Medical Center
-
Wauseon, Ohio, Forente stater, 43567
- Fulton County Health Center
-
Xenia, Ohio, Forente stater, 45385
- Ruth G. McMillan Cancer Center at Greene Memorial Hospital
-
-
Oklahoma
-
Tulsa, Oklahoma, Forente stater, 74136
- Natalie Warren Bryant Cancer Center at St. Francis Hospital
-
-
Pennsylvania
-
Allentown, Pennsylvania, Forente stater, 18105
- Morgan Cancer Center at Lehigh Valley Hospital - Cedar Crest
-
-
South Carolina
-
Anderson, South Carolina, Forente stater, 29621
- AnMed Cancer Center
-
Spartanburg, South Carolina, Forente stater, 29303
- CCOP - Upstate Carolina
-
Spartanburg, South Carolina, Forente stater, 29303
- Gibbs Regional Cancer Center at Spartanburg Regional Medical Center
-
-
South Dakota
-
Sioux Falls, South Dakota, Forente stater, 57105
- Avera Cancer Institute
-
Sioux Falls, South Dakota, Forente stater, 57105
- Medical X-Ray Center, PC
-
Sioux Falls, South Dakota, Forente stater, 57117-5039
- Sanford Cancer Center at Sanford USD Medical Center
-
-
Virginia
-
Fredericksburg, Virginia, Forente stater, 22401
- Hematology-Oncology Associates of Fredericksburg, Incorporated
-
-
Wisconsin
-
La Crosse, Wisconsin, Forente stater, 54601
- Franciscan Skemp Healthcare - La Crosse Campus
-
-
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
DISEASE CHARACTERISTICS:
Histologically confirmed diffuse large B-cell lymphoma
- B-cell phenotype (CD20+) as determined by immunohistochemistry (IHC) or flow cytometry
- Stage II, III, or IV disease
- CD22+ tumor by IHC*
NOTE: *CD22 status may be determined after study enrollment
- Measurable disease, defined as at least 1 lesion ≥ 1.5 cm by CT scan or physical exam
- No relapsed or refractory non-Hodgkin's lymphoma
- No history of transformed lymphoma
No CNS lymphoma
- CNS symptoms or bone marrow or sinus involvement must have absence of CNS lymphoma confirmed by lumbar puncture
PATIENT CHARACTERISTICS:
Eastern Cooperative Oncology Group (ECOG) performance status (PS) 0-3
- For patients with ECOG PS 3, the PS must be disease related
- Absolute neutrophil count ≥ 1,500/mm^3
- Platelet count ≥ 100,000/mm^3
- Total bilirubin ≤ 2 mg/dL (if total bilirubin > 2 mg/dL, direct bilirubin should be within normal limits)
- AST ≤ 3 times upper limit of normal (ULN) (5 times ULN if there is liver involvement)
- Creatinine ≤ 2 times ULN
- Life expectancy ≥ 12 weeks
- Negative pregnancy test
- Not pregnant or nursing
- Fertile patients must use effective contraception during and for 12 months after completion of study treatment
- No active serious infection requiring antibiotics
- No New York Heart Association class III or IV heart disease
- No other primary malignancy within the past 5 years, except for squamous cell or basal cell carcinoma of the skin, in situ carcinoma of the cervix, or previously treated prostate cancer with a stable prostate-specific antigen
- No known HIV positivity
- No known hepatitis B or C infection
- Ejection fraction ≥ 45% by MUGA or echocardiogram (required if patients has a history of heart disease or is ≥ 50 years old)
- Willing to provide blood and tissue samples for mandatory translational research component of study
PRIOR CONCURRENT THERAPY:
No prior therapy for diffuse large B-cell lymphoma, including the following:
- Chemotherapy
- Immunotherapy
- Biologic therapy
- Radiotherapy
- Prior short course (≤ 14 days) of corticosteroids allowed
- Prior splenectomy allowed
- No prior pelvic irradiation
- No other concurrent investigational agents
- No concurrent chemotherapy, immunotherapy, or radiotherapy
- No concurrent enrollment on another treatment study involving a pharmacologic agent (e.g., drugs, biologics, immunotherapy, or gene 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: Epratuzumab + Rituximab + CHOP
One arm open label.
|
Hva måler studien?
Primære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
|
Event-free Survival After 12 Months
Tidsramme: From Baseline to 12 months
|
The primary endpoint of the trial was the percentage of the eligible patients who were alive and event-free 12 months after enrollment to the study (EFS12).
|
From Baseline to 12 months
|
Sekundære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
|
Overall Survival
Tidsramme: time from study entry to 36 months
|
Percentage of participants alive at different time points
|
time from study entry to 36 months
|
|
Progression-free Survival (PFS)
Tidsramme: the time from study entry to 36 months
|
Percentage of participants Progression-free at different time points.
Response was assessed using International Workshop Response Criteria.38
Response is based on CT alone.
Relapse or progression is defined as Enlarging liver/spleen, new sites, New or increased lymph nodes, New or Increased lymph node masses, bone marrow reappearance.
|
the time from study entry to 36 months
|
|
Overall Response Rate (ORR)
Tidsramme: Baseline to first 6 cycles of treatment
|
Overall response rate will be estimated by the number of patients with objective status of partial response (PR), unconfirmed complete response (CRu), or complete response (CR) during the first 6 cycles of treatment divided by number of evaluable patients (met eligibility criteria, signed consent form, and started treatment).
Response was assessed using International Workshop Response Criteria.38
Response is based on CT alone.
Relapse or progression is defined as Enlarging liver/spleen, new sites, New or increased lymph nodes, New or Increased lymph node masses, bone marrow reappearance.
|
Baseline to first 6 cycles of treatment
|
Samarbeidspartnere og etterforskere
Det er her du vil finne personer og organisasjoner som er involvert i denne studien.
Samarbeidspartnere
Etterforskere
- Studiestol: Ivana Micallef, MD, Mayo Clinic
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.
Generelle publikasjoner
- Ghesquieres H, Larrabee BR, Haioun C, Link BK, Verney A, Slager SL, Ketterer N, Ansell SM, Delarue R, Maurer MJ, Fitoussi O, Habermann TM, Peyrade F, Dogan A, Molina TJ, Novak AJ, Tilly H, Cerhan JR, Salles G. FCGR3A/2A polymorphisms and diffuse large B-cell lymphoma outcome treated with immunochemotherapy: a meta-analysis on 1134 patients from two prospective cohorts. Hematol Oncol. 2017 Dec;35(4):447-455. doi: 10.1002/hon.2305. Epub 2016 Jun 10.
- Micallef IN, Kahl BS, Maurer MJ, Dogan A, Ansell SM, Colgan JP, Geyer S, Inwards DJ, White WL, Habermann TM. A pilot study of epratuzumab and rituximab in combination with cyclophosphamide, doxorubicin, vincristine, and prednisone chemotherapy in patients with previously untreated, diffuse large B-cell lymphoma. Cancer. 2006 Dec 15;107(12):2826-32. doi: 10.1002/cncr.22342.
- Maurer MJ, Micallef IN, Cerhan JR, Katzmann JA, Link BK, Colgan JP, Habermann TM, Inwards DJ, Markovic SN, Ansell SM, Porrata LF, Johnston PB, Nowakowski GS, Thompson CA, Gupta M, Syrbu SI, Kurtin PJ, Macon WR, Nikcevich DA, Witzig TE. Elevated serum free light chains are associated with event-free and overall survival in two independent cohorts of patients with diffuse large B-cell lymphoma. J Clin Oncol. 2011 Apr 20;29(12):1620-6. doi: 10.1200/JCO.2010.29.4413. Epub 2011 Mar 7.
- Micallef IN, Maurer MJ, Wiseman GA, Nikcevich DA, Kurtin PJ, Cannon MW, Perez DG, Soori GS, Link BK, Habermann TM, Witzig TE. Epratuzumab with rituximab, cyclophosphamide, doxorubicin, vincristine, and prednisone chemotherapy in patients with previously untreated diffuse large B-cell lymphoma. Blood. 2011 Oct 13;118(15):4053-61. doi: 10.1182/blood-2011-02-336990. Epub 2011 Jun 14.
- Micallef IN, Maurer MJ, Nikcevich DA, et al.: Final results of NCCTG N0489: epratuzumab and rituximab in combination with cyclophosphamide, doxorubicin, vincristine, and prednisone chemotherapy (ER-CHOP) in patients with previously untreated diffuse large B-cell lymphoma. [Abstract] J Clin Oncol 27 (Suppl 15): A-8508, 2009.
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. januar 2006
Primær fullføring (Faktiske)
1. oktober 2008
Studiet fullført (Faktiske)
1. april 2015
Datoer for studieregistrering
Først innsendt
9. mars 2006
Først innsendt som oppfylte QC-kriteriene
9. mars 2006
Først lagt ut (Anslag)
13. mars 2006
Oppdateringer av studieposter
Sist oppdatering lagt ut (Faktiske)
9. oktober 2019
Siste oppdatering sendt inn som oppfylte QC-kriteriene
1. oktober 2019
Sist bekreftet
1. oktober 2019
Mer informasjon
Begreper knyttet til denne studien
Nøkkelord
Ytterligere relevante MeSH-vilkår
- Sykdommer i immunsystemet
- Neoplasmer etter histologisk type
- Neoplasmer
- Lymfoproliferative lidelser
- Lymfesykdommer
- Immunproliferative lidelser
- Lymfom, Non-Hodgkin
- Lymfom, B-celle
- Lymfom
- Lymfom, stor B-celle, diffus
- Fysiologiske effekter av legemidler
- Molekylære mekanismer for farmakologisk virkning
- Enzymhemmere
- Anti-inflammatoriske midler
- Antirevmatiske midler
- Antineoplastiske midler
- Immunsuppressive midler
- Immunologiske faktorer
- Tubulin modulatorer
- Antimitotiske midler
- Mitosemodulatorer
- Glukokortikoider
- Hormoner
- Hormoner, hormonsubstitutter og hormonantagonister
- Antineoplastiske midler, hormonelle
- Antineoplastiske midler, Alkylering
- Alkyleringsmidler
- Myeloablative agonister
- Antineoplastiske midler, fytogene
- Topoisomerase II-hemmere
- Topoisomerasehemmere
- Antineoplastiske midler, immunologiske
- Antibiotika, antineoplastisk
- Cyklofosfamid
- Epratuzumab
- Rituximab
- Prednison
- Doxorubicin
- Liposomal doksorubicin
- Vincristine
Andre studie-ID-numre
- NCCTG-N0489
- NCI-2012-02685 (Registeridentifikator: CTRP (Clinical Trials Reporting System))
- CDR0000459932 (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. .