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)

Non-Hodgkin's Lymphoma (NHL) Clinical Trial

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)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01108341
• Other study ID #: C18083/2048
• Secondary ID: 2009-016725-34
• Status: Completed
• Phase: Phase 2
• First received: April 14, 2010
• Last updated: July 24, 2012
• Start date: May 2010
• Est. completion date: October 2011

Study information

• Verified date: July 2012
• Source: Teva Pharmaceutical Industries
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug AdministrationBelgium: Federal Agency for Medicinal Products and Health ProductsFrance: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)Israel: Israeli Health Ministry Pharmaceutical AdministrationPoland: Office for Registration of Medicinal Products, Medical Devices and Biocidal Products
• Study type: Interventional

Clinical Trial 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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 50
• Est. completion date: October 2011
• Est. primary completion date: July 2011
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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 Design

Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Lymphoma
• Lymphoma, B-Cell
• Lymphoma, Non-Hodgkin
• Non-Hodgkin's Lymphoma (NHL)

Intervention

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.
• 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.

Locations

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

Sponsors (1)

Lead Sponsor	Collaborator
Cephalon

Countries where clinical trial is conducted

United States,  Belgium,  Israel, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	up to Week 32	No
Secondary	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.	up to Week 32	No