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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)

Primary Purpose

Non-Hodgkin's Lymphoma (NHL)

Status
Completed
Phase
Phase 2
Locations
International
Study Type
Interventional
Intervention
Bendamustine hydrochloride
Ofatumumab
Sponsored by
Cephalon
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Non-Hodgkin's Lymphoma (NHL)

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Birmingham Hematology and Oncology Associates, LLC
  • University of Alabama at Birmingham
  • Tower Cancer Research Foundation
  • Hematology Oncology, P.C.
  • University Cancer Institute
  • Florida Cancer Institute - New Hope
  • Dublin Hematology Oncology Care P.C.
  • Northwest Georgia Oncology Center
  • Georgia Cancer Specialists
  • Cancer Care and Hematology Specialists of Chicagoland
  • Siouxland Hematology-Oncology Assoc. LLP
  • Kentucky Cancer Clinic
  • Carroll County Cancer Center
  • Columbia Comprehensive Cancer Care Clinic
  • Nevada Cancer Institute
  • Somerset Hematology Oncology Associates
  • Roswell Park Cancer Institute
  • Monter Cancer Center
  • Mid Dakota Clinic
  • Oregon Health Sciences University
  • University of Pittsburgh Medical Center - Cancer Institute
  • Cancer Centers of the Carolinas
  • The West Clinic
  • Texas Oncology, P.A.
  • MD Anderson Cancer Center
  • Longview Cancer Center
  • Joe Arrington Cancer Research
  • Texas Oncology, P.A.
  • Cancer Care Centers of South Texas
  • Texas Oncology
  • Texas Oncology, P.A.
  • US Oncology Research - Texoma Cancer Center
  • Fairfax/Northern Virginia Hematology/Oncology
  • Yakima Valley Memorial Hospital/North Start Lodge
  • Cephalon Investigational Site
  • Cephalon Investigational Site
  • Cephalon Investigational Site
  • Cephalon Investigational Site
  • Cephalon Investigational Site

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Bendamustine and Ofatumumab

Arm Description

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.

Outcomes

Primary Outcome Measures

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
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.

Secondary Outcome Measures

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
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.

Full Information

First Posted
April 14, 2010
Last Updated
July 24, 2012
Sponsor
Cephalon
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1. Study Identification

Unique Protocol Identification Number
NCT01108341
Brief Title
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)
Official Title
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)
Study Type
Interventional

2. Study Status

Record Verification Date
July 2012
Overall Recruitment Status
Completed
Study Start Date
May 2010 (undefined)
Primary Completion Date
July 2011 (Actual)
Study Completion Date
October 2011 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Cephalon

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
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).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Non-Hodgkin's Lymphoma (NHL)

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
50 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Bendamustine and Ofatumumab
Arm Type
Experimental
Arm Description
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.
Intervention Type
Drug
Intervention Name(s)
Bendamustine hydrochloride
Other Intervention Name(s)
CEP-18083, Treanda
Intervention Description
Bendamustine will be administered at 90 mg/m^2 as a 30-minute intravenous (iv) infusion on days 1 and 2 of each cycle.
Intervention Type
Drug
Intervention Name(s)
Ofatumumab
Other Intervention Name(s)
Arzerra
Intervention Description
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.
Primary Outcome Measure Information:
Title
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
Description
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.
Time Frame
up to Week 32
Secondary Outcome Measure Information:
Title
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
Description
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.
Time Frame
up to Week 32

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Sponsor's Medical Expert
Organizational Affiliation
Cephalon
Official's Role
Study Director
Facility Information:
Facility Name
Birmingham Hematology and Oncology Associates, LLC
City
Birmingham
State/Province
Alabama
ZIP/Postal Code
35235
Country
United States
Facility Name
University of Alabama at Birmingham
City
Birmingham
State/Province
Alabama
ZIP/Postal Code
35294-3300
Country
United States
Facility Name
Tower Cancer Research Foundation
City
Beverly Hills
State/Province
California
ZIP/Postal Code
90211-1850
Country
United States
Facility Name
Hematology Oncology, P.C.
City
Stamford
State/Province
Connecticut
ZIP/Postal Code
06902
Country
United States
Facility Name
University Cancer Institute
City
Boynton Beach
State/Province
Florida
ZIP/Postal Code
33435
Country
United States
Facility Name
Florida Cancer Institute - New Hope
City
New Port Richey
State/Province
Florida
ZIP/Postal Code
34655
Country
United States
Facility Name
Dublin Hematology Oncology Care P.C.
City
Dublin
State/Province
Georgia
ZIP/Postal Code
31021
Country
United States
Facility Name
Northwest Georgia Oncology Center
City
Marietta
State/Province
Georgia
ZIP/Postal Code
30060
Country
United States
Facility Name
Georgia Cancer Specialists
City
Tucker
State/Province
Georgia
ZIP/Postal Code
30084
Country
United States
Facility Name
Cancer Care and Hematology Specialists of Chicagoland
City
Niles
State/Province
Illinois
ZIP/Postal Code
60714
Country
United States
Facility Name
Siouxland Hematology-Oncology Assoc. LLP
City
Sioux City
State/Province
Iowa
ZIP/Postal Code
51101
Country
United States
Facility Name
Kentucky Cancer Clinic
City
Hazard
State/Province
Kentucky
ZIP/Postal Code
41701
Country
United States
Facility Name
Carroll County Cancer Center
City
Westminster
State/Province
Maryland
ZIP/Postal Code
21157
Country
United States
Facility Name
Columbia Comprehensive Cancer Care Clinic
City
Jefferson City
State/Province
Missouri
ZIP/Postal Code
65109
Country
United States
Facility Name
Nevada Cancer Institute
City
Las Vegas
State/Province
Nevada
ZIP/Postal Code
89135
Country
United States
Facility Name
Somerset Hematology Oncology Associates
City
Somerville
State/Province
New Jersey
ZIP/Postal Code
08876
Country
United States
Facility Name
Roswell Park Cancer Institute
City
Buffalo
State/Province
New York
ZIP/Postal Code
14263
Country
United States
Facility Name
Monter Cancer Center
City
Lake Success
State/Province
New York
ZIP/Postal Code
11042
Country
United States
Facility Name
Mid Dakota Clinic
City
Bismarck
State/Province
North Dakota
ZIP/Postal Code
58504
Country
United States
Facility Name
Oregon Health Sciences University
City
Portland
State/Province
Oregon
ZIP/Postal Code
97239
Country
United States
Facility Name
University of Pittsburgh Medical Center - Cancer Institute
City
Pittsburgh
State/Province
Pennsylvania
ZIP/Postal Code
15232
Country
United States
Facility Name
Cancer Centers of the Carolinas
City
Greenville
State/Province
South Carolina
ZIP/Postal Code
29605
Country
United States
Facility Name
The West Clinic
City
Memphis
State/Province
Tennessee
ZIP/Postal Code
38138
Country
United States
Facility Name
Texas Oncology, P.A.
City
Bedford
State/Province
Texas
ZIP/Postal Code
76022
Country
United States
Facility Name
MD Anderson Cancer Center
City
Houston
State/Province
Texas
ZIP/Postal Code
77030-4009
Country
United States
Facility Name
Longview Cancer Center
City
Longview
State/Province
Texas
ZIP/Postal Code
75601
Country
United States
Facility Name
Joe Arrington Cancer Research
City
Lubbock
State/Province
Texas
ZIP/Postal Code
79410
Country
United States
Facility Name
Texas Oncology, P.A.
City
McAllen
State/Province
Texas
ZIP/Postal Code
78503
Country
United States
Facility Name
Cancer Care Centers of South Texas
City
San Antonio
State/Province
Texas
ZIP/Postal Code
78229
Country
United States
Facility Name
Texas Oncology
City
Waco
State/Province
Texas
ZIP/Postal Code
76712
Country
United States
Facility Name
Texas Oncology, P.A.
City
Webster
State/Province
Texas
ZIP/Postal Code
77598
Country
United States
Facility Name
US Oncology Research - Texoma Cancer Center
City
Wichita Falls
State/Province
Texas
ZIP/Postal Code
76310
Country
United States
Facility Name
Fairfax/Northern Virginia Hematology/Oncology
City
Fairfax
State/Province
Virginia
ZIP/Postal Code
22031
Country
United States
Facility Name
Yakima Valley Memorial Hospital/North Start Lodge
City
Yakima
State/Province
Washington
ZIP/Postal Code
98902
Country
United States
Facility Name
Cephalon Investigational Site
City
Bruxelles
ZIP/Postal Code
1000
Country
Belgium
Facility Name
Cephalon Investigational Site
City
Bruxelles
ZIP/Postal Code
1200
Country
Belgium
Facility Name
Cephalon Investigational Site
City
Gent
Country
Belgium
Facility Name
Cephalon Investigational Site
City
Haifa
ZIP/Postal Code
31096
Country
Israel
Facility Name
Cephalon Investigational Site
City
Nahariya
ZIP/Postal Code
22100
Country
Israel

12. IPD Sharing Statement

Citations:
PubMed Identifier
25630297
Citation
Czuczman MS, Kahanic S, Forero A, Davis G, Munteanu M, Van Den Neste E, Offner F, Bron D, Quick D, Fowler N. Results of a phase II study of bendamustine and ofatumumab in untreated indolent B cell non-Hodgkin's lymphoma. Ann Hematol. 2015 Apr;94(4):633-41. doi: 10.1007/s00277-014-2269-8. Epub 2015 Jan 30.
Results Reference
derived

Learn more about this trial

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)

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