Study to Evaluate the Efficacy and Safety of Treatment With Bendamustine in Combination With Ofatumumab in Previously Untreated Patients With Indolent B-Cell Non-Hodgkin's Lymphoma (NHL)
24. juli 2012 oppdatert av: Cephalon
An Open-Label Study to Evaluate the Efficacy and Safety of Treatment With Bendamustine in Combination With Ofatumumab in Previously Untreated Patients With Indolent B-Cell Non-Hodgkin's Lymphoma (NHL)
The primary objective of the study is to determine the efficacy, as measured by overall response (complete response + partial response) of bendamustine in combination with ofatumumab in previously untreated patients with indolent B-Cell Non-Hodgkin's Lymphoma (NHL).
Studieoversikt
Status
Fullført
Forhold
Intervensjon / Behandling
Studietype
Intervensjonell
Registrering (Faktiske)
50
Fase
- Fase 2
Kontakter og plasseringer
Denne delen inneholder kontaktinformasjon for de som utfører studien, og informasjon om hvor denne studien blir utført.
Studiesteder
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Bruxelles, Belgia, 1000
- Cephalon Investigational Site
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Bruxelles, Belgia, 1200
- Cephalon Investigational Site
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Gent, Belgia
- Cephalon Investigational Site
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Alabama
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Birmingham, Alabama, Forente stater, 35294-3300
- University of Alabama at Birmingham
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Birmingham, Alabama, Forente stater, 35235
- Birmingham Hematology and Oncology Associates, LLC
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California
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Beverly Hills, California, Forente stater, 90211-1850
- Tower Cancer Research Foundation
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Connecticut
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Stamford, Connecticut, Forente stater, 06902
- Hematology Oncology, P.C.
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Florida
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Boynton Beach, Florida, Forente stater, 33435
- University Cancer Institute
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New Port Richey, Florida, Forente stater, 34655
- Florida Cancer Institute - New Hope
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Georgia
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Dublin, Georgia, Forente stater, 31021
- Dublin Hematology Oncology Care P.C.
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Marietta, Georgia, Forente stater, 30060
- Northwest Georgia Oncology Center
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Tucker, Georgia, Forente stater, 30084
- Georgia Cancer Specialists
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Illinois
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Niles, Illinois, Forente stater, 60714
- Cancer Care and Hematology Specialists of Chicagoland
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Iowa
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Sioux City, Iowa, Forente stater, 51101
- Siouxland Hematology-Oncology Assoc. LLP
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Kentucky
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Hazard, Kentucky, Forente stater, 41701
- Kentucky Cancer Clinic
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Maryland
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Westminster, Maryland, Forente stater, 21157
- Carroll County Cancer Center
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Missouri
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Jefferson City, Missouri, Forente stater, 65109
- Columbia Comprehensive Cancer Care Clinic
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Nevada
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Las Vegas, Nevada, Forente stater, 89135
- Nevada Cancer Institute
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New Jersey
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Somerville, New Jersey, Forente stater, 08876
- Somerset Hematology Oncology Associates
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New York
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Buffalo, New York, Forente stater, 14263
- Roswell Park Cancer Institute
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Lake Success, New York, Forente stater, 11042
- Monter Cancer Center
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North Dakota
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Bismarck, North Dakota, Forente stater, 58504
- Mid Dakota Clinic
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Oregon
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Portland, Oregon, Forente stater, 97239
- Oregon Health Sciences University
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Pennsylvania
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Pittsburgh, Pennsylvania, Forente stater, 15232
- University of Pittsburgh Medical Center - Cancer Institute
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South Carolina
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Greenville, South Carolina, Forente stater, 29605
- Cancer Centers of the Carolinas
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Tennessee
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Memphis, Tennessee, Forente stater, 38138
- The West Clinic
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Texas
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Bedford, Texas, Forente stater, 76022
- Texas Oncology, P.A.
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Houston, Texas, Forente stater, 77030-4009
- MD Anderson Cancer Center
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Longview, Texas, Forente stater, 75601
- Longview Cancer Center
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Lubbock, Texas, Forente stater, 79410
- Joe Arrington Cancer Research
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McAllen, Texas, Forente stater, 78503
- Texas Oncology, P.A.
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San Antonio, Texas, Forente stater, 78229
- Cancer Care Centers of South Texas
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Waco, Texas, Forente stater, 76712
- Texas Oncology
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Webster, Texas, Forente stater, 77598
- Texas Oncology, P.A.
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Wichita Falls, Texas, Forente stater, 76310
- US Oncology Research - Texoma Cancer Center
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Virginia
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Fairfax, Virginia, Forente stater, 22031
- Fairfax/Northern Virginia Hematology/Oncology
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Washington
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Yakima, Washington, Forente stater, 98902
- Yakima Valley Memorial Hospital/North Start Lodge
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Haifa, Israel, 31096
- Cephalon Investigational Site
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Nahariya, Israel, 22100
- Cephalon Investigational Site
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Deltakelseskriterier
Forskere ser etter personer som passer til en bestemt beskrivelse, kalt kvalifikasjonskriterier. Noen eksempler på disse kriteriene er en persons generelle helsetilstand eller tidligere behandlinger.
Kvalifikasjonskriterier
Alder som er kvalifisert for studier
18 år og eldre (Voksen, Eldre voksen)
Tar imot friske frivillige
Nei
Kjønn som er kvalifisert for studier
Alle
Beskrivelse
Key Inclusion Criteria:
- The patient has histopathologic confirmation of one of the protocol-specific CD20+ B-cell non-Hodgkin's lymphomas. Tissue diagnostic procedures must be performed within 6 months of study entry and with biopsy material available for review.
The patient meets 1 of the following need-for-treatment criteria:
Presence of at least 1 of the following B-symptoms:
- fever (>38ºC) of unclear etiology
- night sweats
- weight loss of greater than 10% within the prior 6 months
- large tumor mass (bulky disease) characterized by lymphomas with a diameter of more than 3 cm in 3 or more regions or by a lymphoma with a diameter of more than 7 cm in 1 region
- presence of lymphoma-related complications
- hyperviscosity syndrome due to monoclonal gammopathy
- The patient's tumor is verified to be CD20+ positive from current or previous excisional or incisional tissue diagnostic procedures performed within 6 months of study entry.
- The screening phase CT scan (based on local evaluation) shows:
- 2 or more clearly demarcated lesions with a largest diameter ≥1.5 cm, or
- 1 clearly demarcated lesion with a largest diameter ≥2.0 cm
- The patient was not previously treated for indolent lymphoma (with the exception of a single course of local radiation therapy not exceeding 2 adjacent lymph node regions).
- The patient has adequate hematologic and hepatic function.
- The patient has Eastern Cooperative Oncology Group (ECOG) performance status 0, 1, or 2.
- The patient has serum creatinine of 2.0 mg/dL or less or creatinine clearance of 30 mL/min or more, based on the Cockcroft-Gault method, or from a 24-hour urine collection.
- The patient is willing to comply with contraception requirements.
Key Exclusion Criteria:
The patient:
- Has small lymphocytic lymphoma or mantle cell lymphoma.
- Has documented history of central nervous system (CNS) lymphomatous involvement.
- Has or has had an active malignancy, other than NHL, within the past 3 years except for localized prostate cancer without evidence of bone metastases, bladder, cervical, or breast carcinoma in-situ, or non-melanoma skin cancer .
- Has New York Heart Association (NYHC) Class III or IV heart failure, uncontrolled arrythmias or unstable angina, electrocardiographic evidence of active ischemia or active conduction system abnormalities, or myocardial infarction within the last 6 months.
- Has known human immunodeficiency virus (HIV) infection.
- Has acute or chronic hepatitis B or hepatitis C infection.
- Is a pregnant or lactating woman. (Any women becoming pregnant during the study will be withdrawn from the study.)
- Has any serious uncontrolled, medical or psychological disorder that would impair the ability of the subject to receive study drugs.
- Has received another investigational agent within 30 days of study entry.
- Has known hypersensitivity to mannitol.
- Has Ann Arbor stage I disease.
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 |
|---|---|
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Eksperimentell: Bendamustine and Ofatumumab
There are 6 planned and 2 optional 28-day cycles in which participants are administered both bendamustine and ofatumumab in the following doses: Bendamustine administered at 90 mg/m^2 intravenously (iv) on study days 1 and 2. Ofatumumab administered at 300 mg iv on day 1 and 1000 mg iv on day 8 of cycle 1.
Ofatumumab administered at 1000 mg iv on day 1 of all additional cycles.
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Bendamustine will be administered at 90 mg/m^2 as a 30-minute intravenous (iv) infusion on days 1 and 2 of each cycle.
Andre navn:
Ofatumumab will be administered at 300 mg as an iv infusion on day 1 and 1000 mg on day 8 of cycle 1 and 1000 mg on day 1 of each subsequent cycle.
Andre navn:
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Hva måler studien?
Primære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
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Percentage of Participants With a Best Overall Response of Complete Response (CR) or Partial Response (PR), as Determined by the International Working Group (IWG) Criteria As Assessed by Investigators
Tidsramme: up to Week 32
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The IWG criteria (Cheson et al 2007) for a CR is a complete disappearance of all detectable clinical evidence of disease and disease-related symptoms if present before therapy.
A PR is at least a 50% decrease in sum of the product of the diameters (SPD) of up to 6 of the largest dominant nodes or nodal masses, no increase should be observed in the size of other nodes, liver or spleen, and no new sites of disease should be observed.
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up to Week 32
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Sekundære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
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Percentage of Participants With a Best Overall Response of Complete Response (CR), as Determined by the International Working Group (IWG) Criteria As Assessed by Investigators
Tidsramme: up to Week 32
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The IWG criteria (Cheson et al 2007) for a CR is a complete disappearance of all detectable clinical evidence of disease and disease-related symptoms if present before therapy.
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up to Week 32
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Samarbeidspartnere og etterforskere
Det er her du vil finne personer og organisasjoner som er involvert i denne studien.
Sponsor
Publikasjoner og nyttige lenker
Den som er ansvarlig for å legge inn informasjon om studien leverer frivillig disse publikasjonene. Disse kan handle om alt relatert til studiet.
Studierekorddatoer
Disse datoene sporer fremdriften for innsending av studieposter og sammendragsresultater til ClinicalTrials.gov. Studieposter og rapporterte resultater gjennomgås av National Library of Medicine (NLM) for å sikre at de oppfyller spesifikke kvalitetskontrollstandarder før de legges ut på det offentlige nettstedet.
Studer hoveddatoer
Studiestart
1. mai 2010
Primær fullføring (Faktiske)
1. juli 2011
Studiet fullført (Faktiske)
1. oktober 2011
Datoer for studieregistrering
Først innsendt
14. april 2010
Først innsendt som oppfylte QC-kriteriene
20. april 2010
Først lagt ut (Anslag)
22. april 2010
Oppdateringer av studieposter
Sist oppdatering lagt ut (Anslag)
28. august 2012
Siste oppdatering sendt inn som oppfylte QC-kriteriene
24. juli 2012
Sist bekreftet
1. juli 2012
Mer informasjon
Begreper knyttet til denne studien
Ytterligere relevante MeSH-vilkår
- Sykdommer i immunsystemet
- Neoplasmer etter histologisk type
- Neoplasmer
- Lymfoproliferative lidelser
- Lymfesykdommer
- Immunproliferative lidelser
- Lymfom
- Lymfom, B-celle
- Lymfom, Non-Hodgkin
- Molekylære mekanismer for farmakologisk virkning
- Antineoplastiske midler
- Antineoplastiske midler, Alkylering
- Alkyleringsmidler
- Bendamustinhydroklorid
- Ofatumumab
Andre studie-ID-numre
- C18083/2048
- 2009-016725-34 (EudraCT-nummer)
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. .