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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 opdateret af: 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).

Studieoversigt

Status

Afsluttet

Betingelser

Intervention / Behandling

Undersøgelsestype

Interventionel

Tilmelding (Faktiske)

50

Fase

  • Fase 2

Kontakter og lokationer

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

Studiesteder

  • Belgien
      • Bruxelles, Belgien, 1000
        • Cephalon Investigational Site
      • Bruxelles, Belgien, 1200
        • Cephalon Investigational Site
      • Gent, Belgien
        • Cephalon Investigational Site
  • Forenede Stater
    • Alabama
      • Birmingham, Alabama, Forenede Stater, 35294-3300
        • University of Alabama at Birmingham
      • Birmingham, Alabama, Forenede Stater, 35235
        • Birmingham Hematology and Oncology Associates, LLC
    • California
      • Beverly Hills, California, Forenede Stater, 90211-1850
        • Tower Cancer Research Foundation
    • Connecticut
      • Stamford, Connecticut, Forenede Stater, 06902
        • Hematology Oncology, P.C.
    • Florida
      • Boynton Beach, Florida, Forenede Stater, 33435
        • University Cancer Institute
      • New Port Richey, Florida, Forenede Stater, 34655
        • Florida Cancer Institute - New Hope
    • Georgia
      • Dublin, Georgia, Forenede Stater, 31021
        • Dublin Hematology Oncology Care P.C.
      • Marietta, Georgia, Forenede Stater, 30060
        • Northwest Georgia Oncology Center
      • Tucker, Georgia, Forenede Stater, 30084
        • Georgia Cancer Specialists
    • Illinois
      • Niles, Illinois, Forenede Stater, 60714
        • Cancer Care and Hematology Specialists of Chicagoland
    • Iowa
      • Sioux City, Iowa, Forenede Stater, 51101
        • Siouxland Hematology-Oncology Assoc. LLP
    • Kentucky
      • Hazard, Kentucky, Forenede Stater, 41701
        • Kentucky Cancer Clinic
    • Maryland
      • Westminster, Maryland, Forenede Stater, 21157
        • Carroll County Cancer Center
    • Missouri
      • Jefferson City, Missouri, Forenede Stater, 65109
        • Columbia Comprehensive Cancer Care Clinic
    • Nevada
      • Las Vegas, Nevada, Forenede Stater, 89135
        • Nevada Cancer Institute
    • New Jersey
      • Somerville, New Jersey, Forenede Stater, 08876
        • Somerset Hematology Oncology Associates
    • New York
      • Buffalo, New York, Forenede Stater, 14263
        • Roswell Park Cancer Institute
      • Lake Success, New York, Forenede Stater, 11042
        • Monter Cancer Center
    • North Dakota
      • Bismarck, North Dakota, Forenede Stater, 58504
        • Mid Dakota Clinic
    • Oregon
      • Portland, Oregon, Forenede Stater, 97239
        • Oregon Health Sciences University
    • Pennsylvania
      • Pittsburgh, Pennsylvania, Forenede Stater, 15232
        • University of Pittsburgh Medical Center - Cancer Institute
    • South Carolina
      • Greenville, South Carolina, Forenede Stater, 29605
        • Cancer Centers of the Carolinas
    • Tennessee
      • Memphis, Tennessee, Forenede Stater, 38138
        • The West Clinic
    • Texas
      • Bedford, Texas, Forenede Stater, 76022
        • Texas Oncology, P.A.
      • Houston, Texas, Forenede Stater, 77030-4009
        • MD Anderson Cancer Center
      • Longview, Texas, Forenede Stater, 75601
        • Longview Cancer Center
      • Lubbock, Texas, Forenede Stater, 79410
        • Joe Arrington Cancer Research
      • McAllen, Texas, Forenede Stater, 78503
        • Texas Oncology, P.A.
      • San Antonio, Texas, Forenede Stater, 78229
        • Cancer Care Centers of South Texas
      • Waco, Texas, Forenede Stater, 76712
        • Texas Oncology
      • Webster, Texas, Forenede Stater, 77598
        • Texas Oncology, P.A.
      • Wichita Falls, Texas, Forenede Stater, 76310
        • US Oncology Research - Texoma Cancer Center
    • Virginia
      • Fairfax, Virginia, Forenede Stater, 22031
        • Fairfax/Northern Virginia Hematology/Oncology
    • Washington
      • Yakima, Washington, Forenede Stater, 98902
        • Yakima Valley Memorial Hospital/North Start Lodge
  • Israel
      • Haifa, Israel, 31096
        • Cephalon Investigational Site
      • Nahariya, Israel, 22100
        • Cephalon Investigational Site

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

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:

    1. 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
    2. 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
    3. presence of lymphoma-related complications
    4. 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

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)

Våben og indgreb

Deltagergruppe / Arm
Intervention / Behandling
Eksperimentel: 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.
Medicin: Bendamustine hydrochloride
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 navne:
  • Treanda
  • CEP-18083
Medicin: Ofatumumab
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 navne:
  • Arzerra

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
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
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.
up to Week 32

Sekundære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
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
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.
up to Week 32

Samarbejdspartnere og efterforskere

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

Sponsor

Cephalon

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

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. maj 2010

Primær færdiggørelse (Faktiske)

1. juli 2011

Studieafslutning (Faktiske)

1. oktober 2011

Datoer for studieregistrering

Først indsendt

14. april 2010

Først indsendt, der opfyldte QC-kriterier

20. april 2010

Først opslået (Skøn)

22. april 2010

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Skøn)

28. august 2012

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

24. juli 2012

Sidst verificeret

1. juli 2012

Mere information

Begreber relateret til denne undersøgelse

Yderligere relevante MeSH-vilkår

Andre undersøgelses-id-numre

  • C18083/2048
  • 2009-016725-34 (EudraCT nummer)

Disse oplysninger blev hentet direkte fra webstedet clinicaltrials.gov uden ændringer. Hvis du har nogen anmodninger om at ændre, fjerne eller opdatere dine undersøgelsesoplysninger, bedes du kontakte register@clinicaltrials.gov. Så snart en ændring er implementeret på clinicaltrials.gov, vil denne også blive opdateret automatisk på vores hjemmeside .

Kliniske forsøg med Non-Hodgkins lymfom (NHL)

Kliniske forsøg med Bendamustine hydrochloride

Søg i lignende forsøg

Sponsorer og samarbejdspartnere

Medicinske tilstande

Narkotikainterventioner

CROs by country

CROs in United Arab Emirates

Betingelser

Sjældne sygdomme

Narkotikainterventioner

Kosttilskud

Sponsor / samarbejdspartnere

Placeringer

Abonner