Clinical trial NCT01108341: 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
Overall status: COMPLETED
Phase: PHASE2
Conditions: Non-Hodgkin's Lymphoma (NHL)
Lead sponsor: Teva Branded Pharmaceutical Products R&D, Inc.
Sponsor class: INDUSTRY
First posted: 2010-04-22
Enrollment: 50
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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).


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:

  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.

Primary outcomes:
measure: 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
timeFrame: up to Week 32
Secondary outcomes:
measure: 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
timeFrame: up to Week 32
Other outcomes:
Locations:
city: Birmingham
country: United States
facility: Birmingham Hematology and Oncology Associates, LLC
state: Alabama
city: Birmingham
country: United States
facility: University of Alabama at Birmingham
state: Alabama
city: Beverly Hills
country: United States
facility: Tower Cancer Research Foundation
state: California
city: Stamford
country: United States
facility: Hematology Oncology, P.C.
state: Connecticut
city: Boynton Beach
country: United States
facility: University Cancer Institute
state: Florida
city: New Port Richey
country: United States
facility: Florida Cancer Institute - New Hope
state: Florida
city: Dublin
country: United States
facility: Dublin Hematology Oncology Care P.C.
state: Georgia
city: Marietta
country: United States
facility: Northwest Georgia Oncology Center
state: Georgia
city: Tucker
country: United States
facility: Georgia Cancer Specialists
state: Georgia
city: Niles
country: United States
facility: Cancer Care and Hematology Specialists of Chicagoland
state: Illinois
city: Sioux City
country: United States
facility: Siouxland Hematology-Oncology Assoc. LLP
state: Iowa
city: Hazard
country: United States
facility: Kentucky Cancer Clinic
state: Kentucky
city: Westminster
country: United States
facility: Carroll County Cancer Center
state: Maryland
city: Jefferson City
country: United States
facility: Columbia Comprehensive Cancer Care Clinic
state: Missouri
city: Las Vegas
country: United States
facility: Nevada Cancer Institute
state: Nevada
city: Somerville
country: United States
facility: Somerset Hematology Oncology Associates
state: New Jersey
city: Buffalo
country: United States
facility: Roswell Park Cancer Institute
state: New York
city: Lake Success
country: United States
facility: Monter Cancer Center
state: New York
city: Bismarck
country: United States
facility: Mid Dakota Clinic
state: North Dakota
city: Portland
country: United States
facility: Oregon Health Sciences University
state: Oregon
city: Pittsburgh
country: United States
facility: University of Pittsburgh Medical Center - Cancer Institute
state: Pennsylvania
city: Greenville
country: United States
facility: Cancer Centers of the Carolinas
state: South Carolina
city: Memphis
country: United States
facility: The West Clinic
state: Tennessee
city: Bedford
country: United States
facility: Texas Oncology, P.A.
state: Texas
city: Houston
country: United States
facility: MD Anderson Cancer Center
state: Texas
city: Longview
country: United States
facility: Longview Cancer Center
state: Texas
city: Lubbock
country: United States
facility: Joe Arrington Cancer Research
state: Texas
city: McAllen
country: United States
facility: Texas Oncology, P.A.
state: Texas
city: San Antonio
country: United States
facility: Cancer Care Centers of South Texas
state: Texas
city: Waco
country: United States
facility: Texas Oncology
state: Texas
city: Webster
country: United States
facility: Texas Oncology, P.A.
state: Texas
city: Wichita Falls
country: United States
facility: US Oncology Research - Texoma Cancer Center
state: Texas
city: Fairfax
country: United States
facility: Fairfax/Northern Virginia Hematology/Oncology
state: Virginia
city: Yakima
country: United States
facility: Yakima Valley Memorial Hospital/North Start Lodge
state: Washington
city: Bruxelles
country: Belgium
facility: Cephalon Investigational Site
city: Bruxelles
country: Belgium
facility: Cephalon Investigational Site
city: Gent
country: Belgium
facility: Cephalon Investigational Site
city: Haifa
country: Israel
facility: Cephalon Investigational Site
city: Nahariya
country: Israel
facility: Cephalon Investigational Site
Study officials:
affiliation: Cephalon
name: Sponsor's Medical Expert
role: STUDY_DIRECTOR
References:
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.