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)

July 24, 2012 updated by: 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).

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

50

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: 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.
Drug: 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.
Other Names:
  • Treanda
  • CEP-18083
Drug: 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.
Other Names:
  • Arzerra

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
Time Frame: 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

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
Time Frame: 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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Cephalon

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

May 1, 2010

Primary Completion (Actual)

July 1, 2011

Study Completion (Actual)

October 1, 2011

Study Registration Dates

First Submitted

April 14, 2010

First Submitted That Met QC Criteria

April 20, 2010

First Posted (Estimate)

April 22, 2010

Study Record Updates

Last Update Posted (Estimate)

August 28, 2012

Last Update Submitted That Met QC Criteria

July 24, 2012

Last Verified

July 1, 2012

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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