Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

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 safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01108341
Recruitment Status : Completed
First Posted : April 22, 2010
Results First Posted : August 28, 2012
Last Update Posted : August 28, 2012
Sponsor:
Information provided by (Responsible Party):
Teva Pharmaceutical Industries ( Cephalon )

Study Type Interventional
Study Design Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition Non-Hodgkin's Lymphoma (NHL)
Interventions Drug: Bendamustine hydrochloride
Drug: Ofatumumab
Enrollment 50
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Bendamustine and Ofatumumab
Hide Arm/Group 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.
Period Title: Overall Study
Started 50
Safety Set (Enrolled and Treated) 49
Completed 45
Not Completed 5
Reason Not Completed
Death             2
Withdrawal by Subject             1
Lost to Follow-up             1
not specified             1
Arm/Group Title Bendamustine and Ofatumumab
Hide Arm/Group 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.
Overall Number of Baseline Participants 49
Hide Baseline Analysis Population Description
[Not Specified]
Age Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 49 participants
59.1  (10.77)
Age, Customized  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 49 participants
<65 years 31
>=65 years 18
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 49 participants
Female
23
  46.9%
Male
26
  53.1%
Ethnicity (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 49 participants
Hispanic or Latino
3
   6.1%
Not Hispanic or Latino
45
  91.8%
Unknown or Not Reported
1
   2.0%
Race/Ethnicity, Customized  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 49 participants
American Indian or Alaska Native 1
Asian 2
Pacific Islander 0
Black 2
White 44
Other 0
1.Primary Outcome
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
Hide 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
Hide Outcome Measure Data
Hide Analysis Population Description
Safety population of participants who were treated
Arm/Group Title Bendamustine and Ofatumumab
Hide Arm/Group 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.
Overall Number of Participants Analyzed 49
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: percentage of participants
90
(77.8 to 96.6)
2.Secondary Outcome
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
Hide 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
Hide Outcome Measure Data
Hide Analysis Population Description
Safety population of participants who were treated
Arm/Group Title Bendamustine and Ofatumumab
Hide Arm/Group 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.
Overall Number of Participants Analyzed 49
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: percentage of participants
67
(52.6 to 80.1)
Time Frame up to 39 weeks
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Bendamustine and Ofatumumab
Hide Arm/Group 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.
All-Cause Mortality
Bendamustine and Ofatumumab
Affected / at Risk (%)
Total   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
Bendamustine and Ofatumumab
Affected / at Risk (%)
Total   14/49 (28.57%) 
Blood and lymphatic system disorders   
Febrile neutropenia  1  2/49 (4.08%) 
Eye disorders   
Diplopia  1  1/49 (2.04%) 
Gastrointestinal disorders   
Ascites  1  1/49 (2.04%) 
Colitis  1  1/49 (2.04%) 
Diarrhoea  1  1/49 (2.04%) 
Faeces discoloured  1  1/49 (2.04%) 
Nausea  1  1/49 (2.04%) 
General disorders   
Infusion related reaction  1  2/49 (4.08%) 
Pyrexia  1  2/49 (4.08%) 
Asthenia  1  1/49 (2.04%) 
Device dislocation  1  1/49 (2.04%) 
Fatigue  1  1/49 (2.04%) 
Hepatobiliary disorders   
Portal vein thrombosis  1  1/49 (2.04%) 
Infections and infestations   
Bacterial sepsis  1  1/49 (2.04%) 
Device related sepsis  1  1/49 (2.04%) 
Gastroenteritis  1  1/49 (2.04%) 
Pneumonia  1  1/49 (2.04%) 
Sepsis  1  1/49 (2.04%) 
Tooth abscess  1  1/49 (2.04%) 
Investigations   
Oxygen saturation decreased  1  1/49 (2.04%) 
Metabolism and nutrition disorders   
Dehydration  1  1/49 (2.04%) 
Failure to thrive  1  1/49 (2.04%) 
Hypercalcaemia  1  1/49 (2.04%) 
Hyperkalaemia  1  1/49 (2.04%) 
Hypophagia  1  1/49 (2.04%) 
Musculoskeletal and connective tissue disorders   
Muscular weakness  1  1/49 (2.04%) 
Neoplasms benign, malignant and unspecified (incl cysts and polyps)   
Non-small cell lung cancer  1  1/49 (2.04%) 
Nervous system disorders   
Depressed level of consciousness  1  1/49 (2.04%) 
Renal and urinary disorders   
Renal failure acute  1  1/49 (2.04%) 
Respiratory, thoracic and mediastinal disorders   
Bronchospasm  1  1/49 (2.04%) 
Sinus congestion  1  1/49 (2.04%) 
Skin and subcutaneous tissue disorders   
Hyperhidrosis  1  1/49 (2.04%) 
Rash  1  1/49 (2.04%) 
Vascular disorders   
Hot flush  1  1/49 (2.04%) 
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA (13.0)
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Bendamustine and Ofatumumab
Affected / at Risk (%)
Total   49/49 (100.00%) 
Blood and lymphatic system disorders   
Neutropenia  1  10/49 (20.41%) 
Leukopenia  1  7/49 (14.29%) 
Anaemia  1  5/49 (10.20%) 
Thrombocytopenia  1  4/49 (8.16%) 
Lymphopenia  1  3/49 (6.12%) 
Cardiac disorders   
Tachycardia  1  5/49 (10.20%) 
Palpitations  1  3/49 (6.12%) 
Eye disorders   
Eye irritation  1  4/49 (8.16%) 
Gastrointestinal disorders   
Nausea  1  29/49 (59.18%) 
Constipation  1  17/49 (34.69%) 
Diarrhoea  1  12/49 (24.49%) 
Vomiting  1  12/49 (24.49%) 
Abdominal pain  1  5/49 (10.20%) 
Gastrooesophageal reflux disease  1  4/49 (8.16%) 
Stomatitis  1  4/49 (8.16%) 
Dyspepsia  1  3/49 (6.12%) 
General disorders   
Fatigue  1  26/49 (53.06%) 
Infusion related reaction  1  20/49 (40.82%) 
Oedema peripheral  1  10/49 (20.41%) 
Pyrexia  1  6/49 (12.24%) 
Chills  1  6/49 (12.24%) 
Asthenia  1  4/49 (8.16%) 
Immune system disorders   
Drug hypersensitivity  1  5/49 (10.20%) 
Infections and infestations   
Sinusitis  1  4/49 (8.16%) 
Upper respiratory tract infection  1  4/49 (8.16%) 
Investigations   
White blood cell count decreased  1  13/49 (26.53%) 
Neutrophil count decreased  1  11/49 (22.45%) 
Platelet count decreased  1  7/49 (14.29%) 
Weight decreased  1  4/49 (8.16%) 
Haemoglobin decreased  1  3/49 (6.12%) 
Metabolism and nutrition disorders   
Decreased appetite  1  7/49 (14.29%) 
Hypokalaemia  1  3/49 (6.12%) 
Hypomagnesaemia  1  3/49 (6.12%) 
Musculoskeletal and connective tissue disorders   
Myalgia  1  7/49 (14.29%) 
Back pain  1  6/49 (12.24%) 
Pain in extremity  1  3/49 (6.12%) 
Nervous system disorders   
Headache  1  12/49 (24.49%) 
Dizziness  1  10/49 (20.41%) 
Dysgeusia  1  4/49 (8.16%) 
Psychiatric disorders   
Insomnia  1  7/49 (14.29%) 
Anxiety  1  4/49 (8.16%) 
Respiratory, thoracic and mediastinal disorders   
Dyspnoea  1  13/49 (26.53%) 
Cough  1  8/49 (16.33%) 
Nasal congestion  1  4/49 (8.16%) 
Rhinitis allergic  1  3/49 (6.12%) 
Skin and subcutaneous tissue disorders   
Rash  1  9/49 (18.37%) 
Pruritus  1  8/49 (16.33%) 
Urticaria  1  8/49 (16.33%) 
Periorbital oedema  1  3/49 (6.12%) 
Vascular disorders   
Hypertension  1  5/49 (10.20%) 
Hypotension  1  3/49 (6.12%) 
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA (13.0)
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Sponsor has the right 60 days before submission for publication to review/provide comments. If the Sponsor’s review shows that potentially patentable subject matter would be disclosed, publication or public disclosure shall be delayed for up to 90 additional days in order for the Sponsor, or Sponsor’s designees, to file the necessary patent applications. In multicenter trials, each PI will postpone single center publications until after disclosure or publication of multicenter data.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Director, Clinical Research
Organization: Teva Branded Pharmaceutical Products, R&D Inc.
Phone: 215-591-3000
EMail: ustevatrials@tevapharm.com
Layout table for additonal information
Responsible Party: Teva Pharmaceutical Industries ( Cephalon )
ClinicalTrials.gov Identifier: NCT01108341     History of Changes
Other Study ID Numbers: C18083/2048
2009-016725-34 ( EudraCT Number )
First Submitted: April 14, 2010
First Posted: April 22, 2010
Results First Submitted: July 24, 2012
Results First Posted: August 28, 2012
Last Update Posted: August 28, 2012