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Monoclonal Antibody Therapy and Combination Chemotherapy in Treating Patients With Stage II, Stage III, or Stage IV Diffuse Large B-Cell Lymphoma

1 ottobre 2019 aggiornato da: 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.

Panoramica dello studio

Stato

Completato

Condizioni

Linfoma

Intervento / Trattamento

Descrizione dettagliata

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.>

Tipo di studio

Interventistico

Iscrizione (Effettivo)

107

Fase

Fase 2

Contatti e Sedi

Questa sezione fornisce i recapiti di coloro che conducono lo studio e informazioni su dove viene condotto lo studio.

Luoghi di studio

Stati Uniti
- Arizona
  - Scottsdale, Arizona, Stati Uniti, 85259-5499
    - Mayo Clinic Scottsdale
- Colorado
  - Aurora, Colorado, Stati Uniti, 80012
    - Aurora Presbyterian Hospital
  - Boulder, Colorado, Stati Uniti, 80301-9019
    - Boulder Community Hospital
  - Colorado Springs, Colorado, Stati Uniti, 80933
    - Penrose Cancer Center at Penrose Hospital
  - Denver, Colorado, Stati Uniti, 80210
    - Porter Adventist Hospital
  - Denver, Colorado, Stati Uniti, 80220
    - Rose Medical Center
  - Denver, Colorado, Stati Uniti, 80218
    - Presbyterian - St. Luke's Medical Center
  - Denver, Colorado, Stati Uniti, 80218
    - St. Joseph Hospital
  - Denver, Colorado, Stati Uniti, 80224-2522
    - CCOP - Colorado Cancer Research Program
  - Englewood, Colorado, Stati Uniti, 80110
    - Swedish Medical Center
  - Fort Collins, Colorado, Stati Uniti, 80524
    - Front Range Cancer Specialists
  - Grand Junction, Colorado, Stati Uniti, 81502
    - St. Mary's Regional Cancer Center at St. Mary's Hospital and Medical Center
  - Lone Tree, Colorado, Stati Uniti, 80124
    - Sky Ridge Medical Center
  - Longmont, Colorado, Stati Uniti, 80502
    - Hope Cancer Care Center at Longmont United Hospital
  - Pueblo, Colorado, Stati Uniti, 81004
    - St. Mary - Corwin Regional Medical Center
  - Thornton, Colorado, Stati Uniti, 80229
    - North Suburban Medical Center
  - Wheat Ridge, Colorado, Stati Uniti, 80033
    - Exempla Lutheran Medical Center
- Florida
  - Jacksonville, Florida, Stati Uniti, 32224
    - Mayo Clinic - Jacksonville
- Illinois
  - Aurora, Illinois, Stati Uniti, 60507
    - Rush-Copley Cancer Care Center
  - Bloomington, Illinois, Stati Uniti, 61701
    - St. Joseph Medical Center
  - Canton, Illinois, Stati Uniti, 61520
    - Graham Hospital
  - Carthage, Illinois, Stati Uniti, 62321
    - Memorial Hospital
  - Eureka, Illinois, Stati Uniti, 61530
    - Eureka Community Hospital
  - Galesburg, Illinois, Stati Uniti, 61401
    - Galesburg Cottage Hospital
  - Galesburg, Illinois, Stati Uniti, 61401
    - Galesburg Clinic
  - Havana, Illinois, Stati Uniti, 62644
    - Mason District Hospital
  - Hopedale, Illinois, Stati Uniti, 61747
    - Hopedale Medical Complex
  - Joliet, Illinois, Stati Uniti, 60435
    - Joliet Oncology-Hematology Associates, Limited - West
  - Kewanee, Illinois, Stati Uniti, 61443
    - Kewanee Hospital
  - Macomb, Illinois, Stati Uniti, 61455
    - Mcdonough District Hospital
  - Moline, Illinois, Stati Uniti, 61265
  - Moline, Illinois, Stati Uniti, 61265
    - Trinity Medical Center - East
  - Normal, Illinois, Stati Uniti, 61761
    - Bromenn Regional Medical Center
  - Normal, Illinois, Stati Uniti, 61761
    - Community Cancer Center
  - Ottawa, Illinois, Stati Uniti, 61350
    - Community Hospital of Ottawa
  - Ottawa, Illinois, Stati Uniti, 61350
    - Oncology Hematology Associates of Central Illinois, PC - Ottawa
  - Pekin, Illinois, Stati Uniti, 61554
    - Cancer Treatment Center at Pekin Hospital
  - Peoria, Illinois, Stati Uniti, 61636
    - Methodist Medical Center of Illinois
  - Peoria, Illinois, Stati Uniti, 61614
    - Proctor Hospital
  - Peoria, Illinois, Stati Uniti, 61637
    - OSF St. Francis Medical Center
  - Peoria, Illinois, Stati Uniti, 61615
    - CCOP - Illinois Oncology Research Association
  - Peoria, Illinois, Stati Uniti, 61615
    - Oncology Hematology Associates of Central Illinois, PC - Peoria
  - Peru, Illinois, Stati Uniti, 61354
    - Illinois Valley Community Hospital
  - Princeton, Illinois, Stati Uniti, 61356
    - Perry Memorial Hospital
  - Spring Valley, Illinois, Stati Uniti, 61362
    - St. Margaret's Hospital
  - Urbana, Illinois, Stati Uniti, 61801
    - Carle Cancer Center at Carle Foundation Hospital
  - Urbana, Illinois, Stati Uniti, 61801
    - CCOP - Carle Cancer Center
- Indiana
  - Beech Grove, Indiana, Stati Uniti, 46107
    - St. Francis Hospital and Health Centers - Beech Grove Campus
  - Michigan City, Indiana, Stati Uniti, 46360
    - Saint Anthony Memorial Health Centers
  - Richmond, Indiana, Stati Uniti, 47374
    - Reid Hospital & Health Care Services, Incorporated
- Iowa
  - Ames, Iowa, Stati Uniti, 50010
    - McFarland Clinic, PC
  - Des Moines, Iowa, Stati Uniti, 50309
    - CCOP - Iowa Oncology Research Association
  - Des Moines, Iowa, Stati Uniti, 50309
    - John Stoddard Cancer Center at Iowa Methodist Medical Center
  - Des Moines, Iowa, Stati Uniti, 50309
    - Medical Oncology and Hematology Associates at John Stoddard Cancer Center
  - Des Moines, Iowa, Stati Uniti, 50314
    - Medical Oncology and Hematology Associates at Mercy Cancer Center
  - Des Moines, Iowa, Stati Uniti, 50314
    - Mercy Cancer Center at Mercy Medical Center - Des Moines
  - Des Moines, Iowa, Stati Uniti, 50307
    - Mercy Capitol Hospital
  - Des Moines, Iowa, Stati Uniti, 50316-2301
    - John Stoddard Cancer Center
  - Mason City, Iowa, Stati Uniti, 50401
    - Mercy Cancer Center at Mercy Medical Center - North Iowa
  - Sioux City, Iowa, Stati Uniti, 51101
    - Siouxland Hematology-Oncology Associates, LLP
  - Sioux City, Iowa, Stati Uniti, 51104
    - St. Luke's Regional Medical Center
  - Sioux City, Iowa, Stati Uniti, 51104
    - Mercy Medical Center - Sioux City
- Kansas
  - Chanute, Kansas, Stati Uniti, 66720
    - Cancer Center of Kansas, PA - Chanute
  - Dodge City, Kansas, Stati Uniti, 67801
    - Cancer Center of Kansas, PA - Dodge City
  - El Dorado, Kansas, Stati Uniti, 67042
    - Cancer Center of Kansas, PA - El Dorado
  - Kingman, Kansas, Stati Uniti, 67068
    - Cancer Center of Kansas, PA - Kingman
  - Liberal, Kansas, Stati Uniti, 67901
    - Southwest Medical Center
  - Newton, Kansas, Stati Uniti, 67114
    - Cancer Center of Kansas, PA - Newton
  - Parsons, Kansas, Stati Uniti, 67357
    - Cancer Center of Kansas, PA - Parsons
  - Pratt, Kansas, Stati Uniti, 67124
    - Cancer Center of Kansas, PA - Pratt
  - Salina, Kansas, Stati Uniti, 67042
    - Cancer Center of Kansas, PA - Salina
  - Wellington, Kansas, Stati Uniti, 67152
    - Cancer Center of Kansas, PA - Wellington
  - Wichita, Kansas, Stati Uniti, 67203
    - Associates in Womens Health, PA - North Review
  - Wichita, Kansas, Stati Uniti, 67208
    - Cancer Center of Kansas, PA - Medical Arts Tower
  - Wichita, Kansas, Stati Uniti, 67214
    - Cancer Center of Kansas, PA - Wichita
  - Wichita, Kansas, Stati Uniti, 67214
    - CCOP - Wichita
  - Wichita, Kansas, Stati Uniti, 67214
    - Via Christi Cancer Center at Via Christi Regional Medical Center
  - Winfield, Kansas, Stati Uniti, 67156
    - Cancer Center of Kansas, PA - Winfield
- Michigan
  - Adrian, Michigan, Stati Uniti, 49221
    - Hickman Cancer Center at Bixby Medical Center
  - Lambertville, Michigan, Stati Uniti, 48144
    - Haematology-Oncology Associates of Ohio and Michigan, PC
  - Monroe, Michigan, Stati Uniti, 48162
    - Community Cancer Center of Monroe
  - Monroe, Michigan, Stati Uniti, 48162
    - Mercy Memorial Hospital - Monroe
- Minnesota
  - Alexandria, Minnesota, Stati Uniti, 56308
  - Bemidji, Minnesota, Stati Uniti, 56601
    - MeritCare Bemidji
  - Burnsville, Minnesota, Stati Uniti, 55337
    - Fairview Ridges Hospital
  - Coon Rapids, Minnesota, Stati Uniti, 55433
    - Mercy and Unity Cancer Center at Mercy Hospital
  - Duluth, Minnesota, Stati Uniti, 55805
    - CCOP - Duluth
  - Duluth, Minnesota, Stati Uniti, 55805-1983
    - Duluth Clinic Cancer Center - Duluth
  - Duluth, Minnesota, Stati Uniti, 55805
    - Miller - Dwan Medical Center
  - Edina, Minnesota, Stati Uniti, 55435
    - Fairview Southdale Hospital
  - Fergus Falls, Minnesota, Stati Uniti, 56537
  - Fridley, Minnesota, Stati Uniti, 55432
    - Mercy and Unity Cancer Center at Unity Hospital
  - Hutchinson, Minnesota, Stati Uniti, 55350
    - Hutchinson Area Health Care
  - Litchfield, Minnesota, Stati Uniti, 55355
    - Meeker County Memorial Hospital
  - Maplewood, Minnesota, Stati Uniti, 55109
    - Minnesota Oncology Hematology, PA - Maplewood
  - Maplewood, Minnesota, Stati Uniti, 55109
    - HealthEast Cancer Care at St. John's Hospital
  - Minneapolis, Minnesota, Stati Uniti, 55407
    - Virginia Piper Cancer Institute at Abbott - Northwestern Hospital
  - Minneapolis, Minnesota, Stati Uniti, 55415
    - Hennepin County Medical Center - Minneapolis
  - Montevideo, Minnesota, Stati Uniti, 56265
    - Chippewa County - Montevideo Hospital and Medical Center
  - Robbinsdale, Minnesota, Stati Uniti, 55422-2900
    - Hubert H. Humphrey Cancer Center at North Memorial Outpatient Center
  - Rochester, Minnesota, Stati Uniti, 55905
    - Mayo Clinic Cancer Center
  - Saint Cloud, Minnesota, Stati Uniti, 56303
    - CentraCare Clinic - River Campus
  - Saint Cloud, Minnesota, Stati Uniti, 56303
    - Coborn Cancer Center
  - Saint Louis Park, Minnesota, Stati Uniti, 55416
    - CCOP - Metro-Minnesota
  - Saint Louis Park, Minnesota, Stati Uniti, 55416
    - Park Nicollet Cancer Center
  - Saint Paul, Minnesota, Stati Uniti, 55102
    - United Hospital
  - Saint Paul, Minnesota, Stati Uniti, 55101
    - Regions Hospital Cancer Care Center
  - Saint Paul, Minnesota, Stati Uniti, 55102
    - HealthEast Cancer Care at St. Joseph's Hospital
  - Shakopee, Minnesota, Stati Uniti, 55379
    - St. Francis Cancer Center at St. Francis Medical Center
  - Waconia, Minnesota, Stati Uniti, 55387
    - Ridgeview Medical Center
  - Woodbury, Minnesota, Stati Uniti, 55125
    - Minnesota Oncology Hematology, PA - Woodbury
  - Woodbury, Minnesota, Stati Uniti, 55125
    - HealthEast Cancer Care at Woodwinds Health Campus
- Nebraska
  - Lincoln, Nebraska, Stati Uniti, 68510
    - Cancer Resource Center - Lincoln
  - Omaha, Nebraska, Stati Uniti, 68106
    - CCOP - Missouri Valley Cancer Consortium
  - Omaha, Nebraska, Stati Uniti, 68122
    - Immanuel Medical Center
  - Omaha, Nebraska, Stati Uniti, 68124
    - Alegant Health Cancer Center at Bergan Mercy Medical Center
  - Omaha, Nebraska, Stati Uniti, 68131-2197
    - Creighton University Medical Center
- North Carolina
  - Rutherfordton, North Carolina, Stati Uniti, 28139
    - Rutherford Hospital
- North Dakota
  - Bismarck, North Dakota, Stati Uniti, 58501
    - Bismarck Cancer Center
  - Bismarck, North Dakota, Stati Uniti, 58501
    - Medcenter One Hospital Cancer Care Center
  - Bismarck, North Dakota, Stati Uniti, 58501
    - Mid Dakota Clinic, PC
  - Bismarck, North Dakota, Stati Uniti, 58502
    - St. Alexius Medical Center Cancer Center
  - Fargo, North Dakota, Stati Uniti, 58122
    - CCOP - MeritCare Hospital
  - Fargo, North Dakota, Stati Uniti, 58122
    - MeritCare Broadway
- Ohio
  - Bowling Green, Ohio, Stati Uniti, 43402
    - Wood County Oncology Center
  - Dayton, Ohio, Stati Uniti, 45428
    - Veterans Affairs Medical Center - Dayton
  - Dayton, Ohio, Stati Uniti, 45405
    - Grandview Hospital
  - Dayton, Ohio, Stati Uniti, 45406
    - Good Samaritan Hospital
  - Dayton, Ohio, Stati Uniti, 45409
    - David L. Rike Cancer Center at Miami Valley Hospital
  - Dayton, Ohio, Stati Uniti, 45415
    - Samaritan North Cancer Care Center
  - Dayton, Ohio, Stati Uniti, 45429
    - CCOP - Dayton
  - Findlay, Ohio, Stati Uniti, 45840
    - Blanchard Valley Medical Associates
  - Fremont, Ohio, Stati Uniti, 43420
    - Fremont Memorial Hospital
  - Kettering, Ohio, Stati Uniti, 45429
    - Charles F. Kettering Memorial Hospital
  - Lima, Ohio, Stati Uniti, 45804
    - Lima Memorial Hospital
  - Maumee, Ohio, Stati Uniti, 43537
    - Northwest Ohio Oncology Center
  - Maumee, Ohio, Stati Uniti, 43537
    - St. Luke's Hospital
  - Middletown, Ohio, Stati Uniti, 45044
    - Middletown Regional Hospital
  - Oregon, Ohio, Stati Uniti, 43616
    - St. Charles Mercy Hospital
  - Oregon, Ohio, Stati Uniti, 43616
    - Toledo Clinic - Oregon
  - Sandusky, Ohio, Stati Uniti, 44870
    - Firelands Regional Medical Center
  - Sandusky, Ohio, Stati Uniti, 44870
    - North Coast Cancer Care, Incorporated
  - Sylvania, Ohio, Stati Uniti, 43560
    - Flower Hospital Cancer Center
  - Tiffin, Ohio, Stati Uniti, 44883
    - Mercy Hospital of Tiffin
  - Toledo, Ohio, Stati Uniti, 43608
    - St. Vincent Mercy Medical Center
  - Toledo, Ohio, Stati Uniti, 43606
    - Toledo Hospital
  - Toledo, Ohio, Stati Uniti, 43614
    - Medical University of Ohio Cancer Center
  - Toledo, Ohio, Stati Uniti, 43617
    - CCOP - Toledo Community Hospital
  - Toledo, Ohio, Stati Uniti, 43623
    - Toledo Clinic, Incorporated - Main Clinic
  - Troy, Ohio, Stati Uniti, 45373-1300
    - UVMC Cancer Care Center at Upper Valley Medical Center
  - Wauseon, Ohio, Stati Uniti, 43567
    - Fulton County Health Center
  - Xenia, Ohio, Stati Uniti, 45385
    - Ruth G. McMillan Cancer Center at Greene Memorial Hospital
- Oklahoma
  - Tulsa, Oklahoma, Stati Uniti, 74136
    - Natalie Warren Bryant Cancer Center at St. Francis Hospital
- Pennsylvania
  - Allentown, Pennsylvania, Stati Uniti, 18105
    - Morgan Cancer Center at Lehigh Valley Hospital - Cedar Crest
- South Carolina
  - Anderson, South Carolina, Stati Uniti, 29621
    - AnMed Cancer Center
  - Spartanburg, South Carolina, Stati Uniti, 29303
    - CCOP - Upstate Carolina
  - Spartanburg, South Carolina, Stati Uniti, 29303
    - Gibbs Regional Cancer Center at Spartanburg Regional Medical Center
- South Dakota
  - Sioux Falls, South Dakota, Stati Uniti, 57105
    - Avera Cancer Institute
  - Sioux Falls, South Dakota, Stati Uniti, 57105
    - Medical X-Ray Center, PC
  - Sioux Falls, South Dakota, Stati Uniti, 57117-5039
    - Sanford Cancer Center at Sanford USD Medical Center
- Virginia
  - Fredericksburg, Virginia, Stati Uniti, 22401
    - Hematology-Oncology Associates of Fredericksburg, Incorporated
- Wisconsin
  - La Crosse, Wisconsin, Stati Uniti, 54601
    - Franciscan Skemp Healthcare - La Crosse Campus

Criteri di partecipazione

I ricercatori cercano persone che corrispondano a una certa descrizione, chiamata criteri di ammissibilità. Alcuni esempi di questi criteri sono le condizioni generali di salute di una persona o trattamenti precedenti.

Criteri di ammissibilità

Età idonea allo studio

18 anni e precedenti (Adulto, Adulto più anziano)

Accetta volontari sani

Sessi ammissibili allo studio

Tutto

Descrizione

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)

Piano di studio

Questa sezione fornisce i dettagli del piano di studio, compreso il modo in cui lo studio è progettato e ciò che lo studio sta misurando.

Come è strutturato lo studio?

Dettagli di progettazione

Scopo principale: Trattamento
Assegnazione: N / A
Modello interventistico: Assegnazione di gruppo singolo
Mascheramento: Nessuno (etichetta aperta)

Numero di armi

Armi e interventi

Gruppo di partecipanti / Arm	Intervento / Trattamento
Sperimentale: Epratuzumab + Rituximab + CHOP One arm open label.	Droga: ciclofosfamide Droga: prednisone Droga: vincristina solfato Droga: doxorubicina cloridrato Biologico: rituximab Biologico: epratuzumab

Cosa sta misurando lo studio?

Misure di risultato primarie

Misura del risultato	Misura Descrizione	Lasso di tempo
Event-free Survival After 12 Months Lasso di tempo: 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

Misure di risultato secondarie

Misura del risultato	Misura Descrizione	Lasso di tempo
Overall Survival Lasso di tempo: 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) Lasso di tempo: 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) Lasso di tempo: 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

Collaboratori e investigatori

Qui è dove troverai le persone e le organizzazioni coinvolte in questo studio.

Sponsor

Alliance for Clinical Trials in Oncology

Collaboratori

National Cancer Institute (NCI)

Investigatori

Cattedra di studio: Ivana Micallef, MD, Mayo Clinic

Pubblicazioni e link utili

La persona responsabile dell'inserimento delle informazioni sullo studio fornisce volontariamente queste pubblicazioni. Questi possono riguardare qualsiasi cosa relativa allo studio.

Pubblicazioni generali

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.

Collegamenti utili

Data Available: Select individual patient-level data from this trial can be requested from the NCTN/NCORP Data Archive

Studiare le date dei record

Queste date tengono traccia dell'avanzamento della registrazione dello studio e dell'invio dei risultati di sintesi a ClinicalTrials.gov. I record degli studi e i risultati riportati vengono esaminati dalla National Library of Medicine (NLM) per assicurarsi che soddisfino specifici standard di controllo della qualità prima di essere pubblicati sul sito Web pubblico.

Studia le date principali

Inizio studio

1 gennaio 2006

Completamento primario (Effettivo)

1 ottobre 2008

Completamento dello studio (Effettivo)

1 aprile 2015

Date di iscrizione allo studio

Primo inviato

9 marzo 2006

Primo inviato che soddisfa i criteri di controllo qualità

9 marzo 2006

Primo Inserito (Stima)

13 marzo 2006

Aggiornamenti dei record di studio

Ultimo aggiornamento pubblicato (Effettivo)

9 ottobre 2019

Ultimo aggiornamento inviato che soddisfa i criteri QC

1 ottobre 2019

Ultimo verificato

1 ottobre 2019

Maggiori informazioni

Termini relativi a questo studio

Parole chiave

Termini MeSH pertinenti aggiuntivi

Altri numeri di identificazione dello studio

NCCTG-N0489
NCI-2012-02685 (Identificatore di registro: CTRP (Clinical Trials Reporting System))
CDR0000459932 (Identificatore di registro: PDQ (Physician Data Query))

Queste informazioni sono state recuperate direttamente dal sito web clinicaltrials.gov senza alcuna modifica. In caso di richieste di modifica, rimozione o aggiornamento dei dettagli dello studio, contattare register@clinicaltrials.gov. Non appena verrà implementata una modifica su clinicaltrials.gov, questa verrà aggiornata automaticamente anche sul nostro sito web .

Monoclonal Antibody Therapy and Combination Chemotherapy in Treating Patients With Stage II, Stage III, or Stage IV Diffuse Large B-Cell Lymphoma

A Phase II Study of Epratuzumab, Rituximab (ER)-CHOP for Patients With Previously Untreated Diffuse Large B-Cell Lymphoma

Panoramica dello studio

Stato

Condizioni

Intervento / Trattamento

Descrizione dettagliata

Tipo di studio

Iscrizione (Effettivo)

Fase

Contatti e Sedi

Luoghi di studio

Criteri di partecipazione

Criteri di ammissibilità

Età idonea allo studio

Accetta volontari sani

Sessi ammissibili allo studio

Descrizione

Piano di studio

Come è strutturato lo studio?

Dettagli di progettazione

Numero di armi

Armi e interventi

Gruppo di partecipanti / Arm

Intervento / Trattamento

Cosa sta misurando lo studio?

Misure di risultato primarie

Misura del risultato

Misura Descrizione

Lasso di tempo

Misure di risultato secondarie

Misura del risultato

Misura Descrizione

Lasso di tempo

Collaboratori e investigatori

Sponsor

Collaboratori

Investigatori

Pubblicazioni e link utili

Pubblicazioni generali

Collegamenti utili

Studiare le date dei record

Studia le date principali

Inizio studio

Completamento primario (Effettivo)

Completamento dello studio (Effettivo)

Date di iscrizione allo studio

Primo inviato

Primo inviato che soddisfa i criteri di controllo qualità

Primo Inserito (Stima)

Aggiornamenti dei record di studio

Ultimo aggiornamento pubblicato (Effettivo)

Ultimo aggiornamento inviato che soddisfa i criteri QC

Ultimo verificato

Maggiori informazioni

Termini relativi a questo studio

Parole chiave

Termini MeSH pertinenti aggiuntivi

Altri numeri di identificazione dello studio

Cerca prove simili

Sponsor e collaboratori

Condizioni mediche

Interventi farmacologici

CROs by country

CROs in Cyprus

Condizioni

Malattie rare

Interventi farmacologici

Supplementi dietetici

Sponsor / Collaboratori

Sedi