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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 uppdaterad 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).

Studieöversikt

Status

Avslutad

Betingelser

Intervention / Behandling

Studietyp

Interventionell

Inskrivning (Faktisk)

50

Fas

  • Fas 2

Kontakter och platser

Det här avsnittet innehåller kontaktuppgifter för dem som genomför studien och information om var denna studie genomförs.

Studieorter

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

Deltagandekriterier

Forskare letar efter personer som passar en viss beskrivning, så kallade behörighetskriterier. Några exempel på dessa kriterier är en persons allmänna hälsotillstånd eller tidigare behandlingar.

Urvalskriterier

Åldrar som är berättigade till studier

18 år och äldre (Vuxen, Äldre vuxen)

Tar emot friska volontärer

Nej

Kön som är behöriga för studier

Allt

Beskrivning

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

Det här avsnittet ger detaljer om studieplanen, inklusive hur studien är utformad och vad studien mäter.

Hur är studien utformad?

Designdetaljer

  • Primärt syfte: Behandling
  • Tilldelning: N/A
  • Interventionsmodell: Enskild gruppuppgift
  • Maskning: Ingen (Open Label)

Vapen och interventioner

Deltagargrupp / Arm
Intervention / Behandling
Experimentell: 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.
Läkemedel: 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.
Andra namn:
  • Treanda
  • CEP-18083
Läkemedel: 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.
Andra namn:
  • Arzerra

Vad mäter studien?

Primära resultatmått

Resultatmått
Åtgärdsbeskrivning
Tidsram
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
Tidsram: 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

Sekundära resultatmått

Resultatmått
Åtgärdsbeskrivning
Tidsram
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
Tidsram: 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

Samarbetspartners och utredare

Det är här du hittar personer och organisationer som är involverade i denna studie.

Sponsor

Cephalon

Publikationer och användbara länkar

Den som ansvarar för att lägga in information om studien tillhandahåller frivilligt dessa publikationer. Dessa kan handla om allt som har med studien att göra.

Allmänna publikationer

Studieavstämningsdatum

Dessa datum spårar framstegen för inlämningar av studieposter och sammanfattande resultat till ClinicalTrials.gov. Studieposter och rapporterade resultat granskas av National Library of Medicine (NLM) för att säkerställa att de uppfyller specifika kvalitetskontrollstandarder innan de publiceras på den offentliga webbplatsen.

Studera stora datum

Studiestart

1 maj 2010

Primärt slutförande (Faktisk)

1 juli 2011

Avslutad studie (Faktisk)

1 oktober 2011

Studieregistreringsdatum

Först inskickad

14 april 2010

Först inskickad som uppfyllde QC-kriterierna

20 april 2010

Första postat (Uppskatta)

22 april 2010

Uppdateringar av studier

Senaste uppdatering publicerad (Uppskatta)

28 augusti 2012

Senaste inskickade uppdateringen som uppfyllde QC-kriterierna

24 juli 2012

Senast verifierad

1 juli 2012

Mer information

Termer relaterade till denna studie

Ytterligare relevanta MeSH-villkor

Andra studie-ID-nummer

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

Denna information hämtades direkt från webbplatsen clinicaltrials.gov utan några ändringar. Om du har några önskemål om att ändra, ta bort eller uppdatera dina studieuppgifter, vänligen kontakta register@clinicaltrials.gov. Så snart en ändring har implementerats på clinicaltrials.gov, kommer denna att uppdateras automatiskt även på vår webbplats .

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