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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. oktober 2019 opdateret af: 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.

Studieoversigt

Status

Afsluttet

Betingelser

Lymfom

Intervention / Behandling

Detaljeret 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.>

Undersøgelsestype

Interventionel

Tilmelding (Faktiske)

107

Fase

Fase 2

Kontakter og lokationer

Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.

Studiesteder

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

Deltagelseskriterier

Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.

Berettigelseskriterier

Aldre berettiget til at studere

18 år og ældre (Voksen, Ældre voksen)

Tager imod sunde frivillige

Ingen

Køn, der er berettiget til at studere

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

Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

Primært formål: Behandling
Tildeling: N/A
Interventionel model: Enkelt gruppeopgave
Maskning: Ingen (Åben etiket)

Antal våben

Våben og indgreb

Deltagergruppe / Arm	Intervention / Behandling
Eksperimentel: Epratuzumab + Rituximab + CHOP One arm open label.	Medicin: cyclophosphamid Medicin: prednison Medicin: vincristinsulfat Medicin: doxorubicin hydrochlorid Biologisk: rituximab Biologisk: epratuzumab

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål	Foranstaltningsbeskrivelse	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	Foranstaltningsbeskrivelse	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

Samarbejdspartnere og efterforskere

Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.

Sponsor

Alliance for Clinical Trials in Oncology

Samarbejdspartnere

National Cancer Institute (NCI)

Efterforskere

Studiestol: Ivana Micallef, MD, Mayo Clinic

Publikationer og nyttige links

Den person, der er ansvarlig for at indtaste oplysninger om undersøgelsen, leverer frivilligt disse publikationer. Disse kan handle om alt relateret til undersøgelsen.

Generelle publikationer

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.

Hjælpsomme links

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

Datoer for undersøgelser

Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.

Studer store datoer

Studiestart

1. januar 2006

Primær færdiggørelse (Faktiske)

1. oktober 2008

Studieafslutning (Faktiske)

1. april 2015

Datoer for studieregistrering

Først indsendt

9. marts 2006

Først indsendt, der opfyldte QC-kriterier

9. marts 2006

Først opslået (Skøn)

13. marts 2006

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Faktiske)

9. oktober 2019

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

1. oktober 2019

Sidst verificeret

1. oktober 2019

Mere information

Begreber relateret til denne undersøgelse

Nøgleord

Yderligere relevante MeSH-vilkår

Andre undersøgelses-id-numre

NCCTG-N0489
NCI-2012-02685 (Registry Identifier: CTRP (Clinical Trials Reporting System))
CDR0000459932 (Registry Identifier: PDQ (Physician Data Query))

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Kliniske forsøg med cyclophosphamid

Children's Hospital Los Angeles
Lucile Packard Children's Hospital

Afsluttet

Relateret hæmatopoietisk stamcelletransplantation (HSCT) for genetiske sygdomme i blodceller

Metaboliske sygdomme | Stamcelletransplantation | Kronisk granulomatøs sygdom | Knoglemarvstransplantation | Thalassæmi | Wiskott-Aldrich syndrom | Genetiske sygdomme | Perifer blodstamcelletransplantation | Pædiatri | Diamond-Blackfan Anæmi | Allogen Transplantation | Kombineret immundefekt | X-bundet lymfoproliferativ...
Medical College of Wisconsin
National Cancer Institute (NCI); National Heart, Lung, and Blood Institute... og andre samarbejdspartnere

Afsluttet

Fludarabin-baseret konditionering til svær aplastisk anæmi (BMT CTN 0301)

Anæmi, aplastisk

Forenede Stater
Centre Oscar Lambret

Afsluttet

Imatinibmesylat og cyclophosphamid i metronomisk administration: dosiseskaleringsundersøgelse af imatinibmesylat (PALANGI3)

Kræft

Frankrig
Institut Bergonié
Merck Sharp & Dohme LLC; National Cancer Institute, France; Transgene; Fondation...

Rekruttering

En undersøgelse af metronomisk CP og JX-594 hos patienter med avanceret brystkræft og avanceret bløddelssarkom (METROmaJX) (METROmaJX)

Brystkræft | Blødt væv sarkom | Faste tumorer

Frankrig
Columbia University

Ukendt

Risikotilpasset allogen stamcelletransplantation til blandet donorkimerisme hos patienter med ikke-maligne sygdomme

Alvorlig kombineret immundefekt | Fanconi Anæmi | Knoglemarvssvigt | Osteopetrose

Forenede Stater
Shandong Cancer Hospital and Institute

Ukendt

Undersøgelse af brystkræftsvindtilstande efter neoadjuverende kemoterapi med helmonterede seriesnit og tredimensionel patologisk og MR-rekonstruktion (BCSMANC)

Brystkræft

Kina
Mahidol University

Afsluttet

Lavdosis VS Højdosis IV cyclophosphamid til proliferativ LN hos børn (Low/highIVCY)

Nyreinsufficiens | Infektion

Thailand
National Cancer Institute, Naples
Immatics Biotechnologies GmbH; CureVac; European Commission -FP7-Health-2013-Innovation-1

Afsluttet

IMA970A Plus CV8102 hos patienter med meget tidligt, tidligt og mellemstadie af hepatocellulært karcinom

Hepatocellulært karcinom

Belgien, Tyskland, Italien, Spanien, Det Forenede Kongerige
University of Turin, Italy

Ukendt

Letrozol Plus Oral Cyclophosphamid Plus/Minus Sorafenib som primær systemisk behandling hos brystkræftpatienter

Brystkræft

Italien
Tao OUYANG

Afsluttet

Sammenlignende effektivitet af tre regimer, CEFci, CEF og EC som neoadjuverende kemoterapi til primær brystkræft

Brystkræft

Kina

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

Studieoversigt

Status

Betingelser

Intervention / Behandling

Detaljeret beskrivelse

Undersøgelsestype

Tilmelding (Faktiske)

Fase

Kontakter og lokationer

Studiesteder

Deltagelseskriterier

Berettigelseskriterier

Aldre berettiget til at studere

Tager imod sunde frivillige

Køn, der er berettiget til at studere

Beskrivelse

Studieplan

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

Antal våben

Våben og indgreb

Deltagergruppe / Arm

Intervention / Behandling

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål

Foranstaltningsbeskrivelse

Tidsramme

Sekundære resultatmål

Resultatmål

Foranstaltningsbeskrivelse

Tidsramme

Samarbejdspartnere og efterforskere

Sponsor

Samarbejdspartnere

Efterforskere

Publikationer og nyttige links

Generelle publikationer

Hjælpsomme links

Datoer for undersøgelser

Studer store datoer

Studiestart

Primær færdiggørelse (Faktiske)

Studieafslutning (Faktiske)

Datoer for studieregistrering

Først indsendt

Først indsendt, der opfyldte QC-kriterier

Først opslået (Skøn)

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Faktiske)

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

Sidst verificeret

Mere information

Begreber relateret til denne undersøgelse

Nøgleord

Yderligere relevante MeSH-vilkår

Andre undersøgelses-id-numre

Kliniske forsøg med cyclophosphamid

Søg i lignende forsøg

Sponsorer og samarbejdspartnere

Medicinske tilstande

Narkotikainterventioner

CROs by country

CROs in Brazil

Betingelser

Sjældne sygdomme

Narkotikainterventioner

Kosttilskud

Sponsor / samarbejdspartnere

Placeringer