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Study of Bendamustine and Ofatumumab in Elderly Patients With Newly Diagnosed Diffuse Large B-Cell Lymphoma Who Are Poor Candidates for R-CHOP Chemotherapy

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ClinicalTrials.gov Identifier: NCT01626352
Recruitment Status : Completed
First Posted : June 22, 2012
Results First Posted : October 18, 2017
Last Update Posted : November 22, 2017
Sponsor:
Collaborators:
Novartis
GlaxoSmithKline
Cephalon
Information provided by (Responsible Party):
SCRI Development Innovations, LLC

Study Type Interventional
Study Design Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition Diffuse Large B-Cell Lymphoma
Interventions Drug: Bendamustine
Drug: Ofatumumab
Enrollment 22
Recruitment Details Between October 2012 to July 2014, 22 subjects with newly diagnosed Diffuse Large B-Cell Lymphoma (DLBCL) were screened for enrollment in the study at 12 investigational sites in the U.S.. Of those, 21 were treated.
Pre-assignment Details  
Arm/Group Title Bendamustine/Ofatumumab
Hide Arm/Group Description

All patients will receive ofatumumab and bendamustine as an intravenous (IV) infusion for 6 cycles (a cycle is defined as 21 days in length).

Bendamustine: via IV infusion, 90 mg/m^2 Days 1 and 2 of Cycles 1 through 6 Ofatumumab: via IV infusion, 1000-mg Days 1 and 8 during Cycle 1 only, and on Day 1 of Cycles 2 through 6

Period Title: Overall Study
Started 22
Completed 12
Not Completed 10
Reason Not Completed
Disease Progression             3
Intercurrent Illness             2
Death             2
Withdrawal by Subject             1
Non-Compliance             1
Never Treated             1
Arm/Group Title Bendamustine/Ofatumumab
Hide Arm/Group Description

All patients in this study will receive ofatumumab and bendamustine as an IV infusion for 6 cycles (a cycle is defined as 21 days in length).

Bendamustine: via IV infusion, 90 mg/m^2 Days 1 and 2 of Cycles 1 through 6 Ofatumumab: via IV infusion, 1000-mg IV Days 1 and 8 during Cycle 1 only and on Day 1 of Cycles 2 through 6

Overall Number of Baseline Participants 21
Hide Baseline Analysis Population Description
Includes all patients that received study drug.
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 21 participants
<=18 years 0
Between 18 and 65 years 0
>=65 years 21
Age, Continuous  
Median (Full Range)
Unit of measure:  Years
Number Analyzed 21 participants
83
(73 to 88)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 21 participants
Female
9
  42.9%
Male
12
  57.1%
Race (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 21 participants
American Indian or Alaska Native
1
   4.8%
Asian
0
   0.0%
Native Hawaiian or Other Pacific Islander
0
   0.0%
Black or African American
0
   0.0%
White
20
  95.2%
More than one race
0
   0.0%
Unknown or Not Reported
0
   0.0%
Region of Enrollment  
Measure Type: Count of Participants
Unit of measure:  Participants
United States Number Analyzed 21 participants
21
1.Primary Outcome
Title Number of Patients With a Complete Response
Hide Description Disease response assessments will be performed using the International Working Group (IMW)-revised response criteria for malignant lymphoma (Cheson 2007). Complete response requires a disappearance of all evidence of disease.
Time Frame 18 months
Hide Outcome Measure Data
Hide Analysis Population Description
All patients treated with study drugs and having a post baseline response assessment.
Arm/Group Title Bendamustine/Ofatumumab
Hide Arm/Group Description:

All patients in this study will receive ofatumumab and bendamustine as an IV infusion for 6 cycles (a cycle is defined as 21 days in length).

Bendamustine: via IV infusion, 90 mg/m^2 Days 1 and 2 of Cycles 1 through 6 Ofatumumab: via IV infusion, 1000-mg IV Days 1 and 8 during Cycle 1 only and on Day 1 of Cycles 2 through 6

Overall Number of Participants Analyzed 21
Measure Type: Count of Participants
Unit of Measure: Participants
7
  33.3%
2.Secondary Outcome
Title Duration of Response
Hide Description Defined as the time from date of first documented confirmed response to date of disease progression or relapse from complete response as defined by the International Working Group (IMW)-revised response criteria for malignant lymphoma (Cheson 2007). This criteria categorizes the response of a patient's tumor to treatment as Complete Response (CR): the disappearance of all disease evidence; Partial Response (PR): regression of measurable disease and no new sites; Stable Disease (SD): less than a PR but not progressive disease (PD); Relapsed Disease or PD: Any new lesion or increase by ≥ 50% of previously involved sites from nadir. Patients who are alive and free from disease progression will be censored at the date of last tumor assessment. Patients who begin further anticancer therapy prior to disease progression will be censored at the date of last tumor assessment prior to the start date of the anticancer therapy.
Time Frame After cycles 3 and 6 of each 21-day cycle and every 3 months thereafter until disease progression or relapse from complete response for up to 38 months
Hide Outcome Measure Data
Hide Analysis Population Description
All patients treated with study drugs and having a post baseline response assessment of a complete or partial response.
Arm/Group Title Bendamustine/Ofatumumab
Hide Arm/Group Description:

All patients in this study will receive ofatumumab and bendamustine as an IV infusion for 6 cycles (a cycle is defined as 21 days in length). Patients will receive as an IV infusion of bendamustine Days 1 and 2 of Cycles 1-6, ofatumumab Days 1 and 8 during Cycle 1 only and on Day 1 of Cycles 2-6.

Bendamustine: Patients will receive as an IV infusion bendamustine 90 mg/m^2 Days 1 and 2 of Cycles 1 through 6.

Ofatumumab: Patients will receive as an IV infusion ofatumumab 1000-mg IV Days 1 and 8 during Cycle 1 only, and on Day 1 of Cycles 2 through 6

Overall Number of Participants Analyzed 19
Median (90% Confidence Interval)
Unit of Measure: months
5.6
(2.9 to 9.8)
3.Secondary Outcome
Title Time to Progression (TTP)
Hide Description Defined as the time from date of first treatment to the date of first documented disease progression or relapse from complete response as defined by the International Working Group (IMW)-revised response criteria for malignant lymphoma (Cheson 2007). This criteria categorizes the response of a patient's tumor to treatment as Complete Response (CR): the disappearance of all disease evidence; Partial Response (PR): regression of measurable disease and no new sites; Stable Disease (SD): less than a PR but not progressive disease (PD); Relapsed Disease or PD: Any new lesion or increase by ≥ 50% of previously involved sites from nadir.
Time Frame After cycles 3 and 6 of each 21-day cycle, and every 3 months thereafter until progression or relapse from complete response for up to 40 months
Hide Outcome Measure Data
Hide Analysis Population Description
All enrolled patients who have received study treatment.
Arm/Group Title Bendamustine/Ofatumumab
Hide Arm/Group Description:

All patients in this study will receive ofatumumab and bendamustine as an IV infusion for 6 cycles (a cycle is defined as 21 days in length).

Bendamustine: via IV infusion, 90 mg/m^2 Days 1 and 2 of Cycles 1 through 6 Ofatumumab: via IV infusion, 1000-mg IV Days 1 and 8 during Cycle 1 only and on Day 1 of Cycles 2 through 6

Overall Number of Participants Analyzed 21
Median (95% Confidence Interval)
Unit of Measure: months
10.5 [1] 
(4.5 to NA)
[1]
Not reached at this time
4.Secondary Outcome
Title Overall Survival (OS)
Hide Description Defined as the time from Day 1 of study drug administration to date of death from any cause.
Time Frame every 3 cycles during treatment and every 3 months thereafter until progression or death from any cause, projected 18 months
Hide Outcome Measure Data
Hide Analysis Population Description
All enrolled patients who have received study treatment.
Arm/Group Title Bendamustine/Ofatumumab
Hide Arm/Group Description:

All patients in this study will receive ofatumumab and bendamustine as an IV infusion for 6 cycles (a cycle is defined as 21 days in length).

Bendamustine: via IV infusion, 90 mg/m^2 Days 1 and 2 of Cycles 1 through 6 Ofatumumab: via IV infusion, 1000-mg IV Days 1 and 8 during Cycle 1 only and on Day 1 of Cycles 2 through 6

Overall Number of Participants Analyzed 21
Median (90% Confidence Interval)
Unit of Measure: months
12.0
(5.9 to 30.8)
5.Secondary Outcome
Title Overall Response (OR)
Hide Description Overall response is the number of patients with observed complete or partial response (CR or PR) as assessed using the International Working Group (IMW) revised response criteria for malignant lymphoma (Cheson 2007). Complete response requires disappearance of all evidence of disease. Partial response requires regression of measurable disease and no new sites.
Time Frame after cycles 3 and 6 of each 21-day cycle, and every 3 months thereafter, projected 18 months
Hide Outcome Measure Data
Hide Analysis Population Description
All patients treated with study drugs and having a post baseline response assessment.
Arm/Group Title Bendamustine/Ofatumumab
Hide Arm/Group Description:

All patients in this study will receive ofatumumab and bendamustine as an IV infusion for 6 cycles (a cycle is defined as 21 days in length). Patients will receive as an IV infusion of bendamustine Days 1 and 2 of Cycles 1-6, ofatumumab Days 1 and 8 during Cycle 1 only and on Day 1 of Cycles 2-6.

Bendamustine: Patients will receive as an IV infusion bendamustine 90 mg/m^2 Days 1 and 2 of Cycles 1 through 6.

Ofatumumab: Patients will receive as an IV infusion ofatumumab 1000-mg IV Days 1 and 8 during Cycle 1 only, and on Day 1 of Cycles 2 through 6

Overall Number of Participants Analyzed 21
Measure Type: Count of Participants
Unit of Measure: Participants
19
  90.5%
6.Secondary Outcome
Title Number of Patients With Treatment-Related Adverse Events (AEs) as a Measure of Safety
Hide Description A treatment-related adverse event was any untoward medical occurrence in a participant which was considered to have a relationship with the study drug (suspected to be possibly or probably related to the study drug per the Investigator’s assessment). Adverse events were evaluated using the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) v4.0.
Time Frame after cycles 3 and 6 of each 21-day cycle, and up to 30 days after last dose, projected 24 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
All enrolled patients who received the study treatment.
Arm/Group Title Bendamustine/Ofatumumab
Hide Arm/Group Description:

All patients in this study will receive ofatumumab and bendamustine as an IV infusion for 6 cycles (a cycle is defined as 21 days in length). Patients will receive as an IV infusion of bendamustine Days 1 and 2 of Cycles 1-6, ofatumumab Days 1 and 8 during Cycle 1 only and on Day 1 of Cycles 2-6 (see Figure 1).

Bendamustine: Patients will receive as an IV infusion bendamustine 90 mg/m^2 Days 1 and 2 of Cycles 1 through 6 and ofatumumab 1000-mg IV Days 1 and 8 during Cycle 1 only and on Day 1 of Cycles 2 through 6(a cycle is defined as 21 days in length).

Ofatumumab: Patients will receive as an IV infusion bendamustine 90 mg/m^2 Days 1 and 2 of Cycles 1 through 6 and ofatumumab 1000-mg IV Days 1 and 8 during Cycle 1 only and on Day 1 of Cycles 2 through 6(a cycle is defined as 21 days in length).

Overall Number of Participants Analyzed 21
Measure Type: Count of Participants
Unit of Measure: Participants
16
  76.2%
7.Secondary Outcome
Title Progression-free Survival
Hide Description Defined as the time from first treatment until objective tumor progression, relapse from complete response, or death from any cause. Tumor response is defined by the International Working Group (IMW)-revised response criteria for malignant lymphoma (Cheson 2007). This criteria categorizes the response of a patient's tumor to treatment as Complete Response (CR): the disappearance of all disease evidence; Partial Response (PR): regression of measurable disease and no new sites; Stable Disease (SD): less than a PR but not progressive disease (PD); Relapsed Disease or PD: Any new lesion or increase by ≥ 50% of previously involved sites from nadir. Patients who are alive and free from disease progression will be censored at the date of last tumor assessment.
Time Frame After cycles 3 and 6 of each 21-day cycle, and every 3 months thereafter until progression or relapse from complete response for up to 40 months
Hide Outcome Measure Data
Hide Analysis Population Description
All enrolled patients who have received study treatment.
Arm/Group Title Bendamustine/Ofatumumab
Hide Arm/Group Description:

All patients will receive ofatumumab and bendamustine as an intravenous (IV) infusion for 6 cycles (a cycle is defined as 21 days in length).

Bendamustine: via IV infusion, 90 mg/m^2 Days 1 and 2 of Cycles 1 through 6 Ofatumumab: via IV infusion, 1000-mg Days 1 and 8 during Cycle 1 only, and on Day 1 of Cycles 2 through 6

Overall Number of Participants Analyzed 21
Median (90% Confidence Interval)
Unit of Measure: months
8.6
(4.6 to 10.6)
Time Frame Collected once per week during cycle 1 and then collected once per month until 30 days after last treatment.
Adverse Event Reporting Description All patients who received at least one dose of protocol treatment are included in the safety analysis.
 
Arm/Group Title Bendamustine/Ofatumumab
Hide Arm/Group Description

All patients in this study will receive ofatumumab and bendamustine as an IV infusion for 6 cycles (a cycle is defined as 21 days in length). Patients will receive as an IV infusion of bendamustine Days 1 and 2 of Cycles 1-6, ofatumumab Days 1 and 8 during Cycle 1 only and on Day 1 of Cycles 2-6 (see Figure 1).

Bendamustine: Patients will receive as an IV infusion bendamustine 90 mg/m^2 Days 1 and 2 of Cycles 1 through 6 and ofatumumab 1000-mg IV Days 1 and 8 during Cycle 1 only and on Day 1 of Cycles 2 through 6(a cycle is defined as 21 days in length).

Ofatumumab: Patients will receive as an IV infusion bendamustine 90 mg/m^2 Days 1 and 2 of Cycles 1 through 6 and ofatumumab 1000-mg IV Days 1 and 8 during Cycle 1 only and on Day 1 of Cycles 2 through 6(a cycle is defined as 21 days in length).

All-Cause Mortality
Bendamustine/Ofatumumab
Affected / at Risk (%)
Total   14/21 (66.67%) 
Show Serious Adverse Events Hide Serious Adverse Events
Bendamustine/Ofatumumab
Affected / at Risk (%)
Total   9/21 (42.86%) 
Gastrointestinal disorders   
Abdominal distension  1  1/21 (4.76%) 
Diarrhoea  1  1/21 (4.76%) 
Gastrointestinal necrosis  1  1/21 (4.76%) 
General disorders   
Death  1  1/21 (4.76%) 
Disease progression  1  1/21 (4.76%) 
Fatigue  1  1/21 (4.76%) 
Infections and infestations   
Pneumonia  1  2/21 (9.52%) 
Abdominal infection  1  1/21 (4.76%) 
Cystitis  1  1/21 (4.76%) 
Urinary tract infection  1  1/21 (4.76%) 
Injury, poisoning and procedural complications   
Fall  1  1/21 (4.76%) 
Investigations   
Haemoglobin decreased  1  1/21 (4.76%) 
Platelet count decreased  1  1/21 (4.76%) 
White blood cell count decreased  1  1/21 (4.76%) 
Metabolism and nutrition disorders   
Dehydration  1  1/21 (4.76%) 
Nervous system disorders   
Syncope  1  1/21 (4.76%) 
Renal and urinary disorders   
Acute kidney injury  1  1/21 (4.76%) 
Respiratory, thoracic and mediastinal disorders   
Dyspnoea  1  1/21 (4.76%) 
Pulmonary embolism  1  1/21 (4.76%) 
Vascular disorders   
Pulmonary Embolism  1  1/21 (4.76%) 
Deep Vein Thrombosis  1  1/21 (4.76%) 
1
Term from vocabulary, MedDRA
Indicates events were collected by systematic assessment
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Bendamustine/Ofatumumab
Affected / at Risk (%)
Total   20/21 (95.24%) 
Blood and lymphatic system disorders   
Anaemia  1  4/21 (19.05%) 
Neutropenia  1  2/21 (9.52%) 
Cardiac disorders   
Chest Pain  1  2/21 (9.52%) 
Gastrointestinal disorders   
Nausea  1  9/21 (42.86%) 
Diarrhoea  1  5/21 (23.81%) 
Constipation  1  4/21 (19.05%) 
Vomiting  1  3/21 (14.29%) 
General disorders   
Fatigue  1  10/21 (47.62%) 
Infusion Related Reaction  1  4/21 (19.05%) 
Oedema Peripheral  1  3/21 (14.29%) 
Asthenia  1  2/21 (9.52%) 
Investigations   
Weight Decreased  1  4/21 (19.05%) 
Neutrophil Count Decreased  1  2/21 (9.52%) 
Platelet Count Decreased  1  2/21 (9.52%) 
Metabolism and nutrition disorders   
Decreased Appetite  1  4/21 (19.05%) 
Hypoglycaemia  1  2/21 (9.52%) 
Hypokalaemia  1  2/21 (9.52%) 
Nervous system disorders   
Headache  1  2/21 (9.52%) 
Psychiatric disorders   
Insomnia  1  2/21 (9.52%) 
Respiratory, thoracic and mediastinal disorders   
Cough  1  6/21 (28.57%) 
Skin and subcutaneous tissue disorders   
Pruritus  1  3/21 (14.29%) 
Urticaria  1  2/21 (9.52%) 
Vascular disorders   
Hypotension  1  2/21 (9.52%) 
1
Term from vocabulary, MedDRA
Indicates events were collected by systematic assessment
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.
The sponsor can review/embargo results communications prior to public release for a period that is >60 days but ≤180 days from date submitted to sponsor, who may require changes to the communication in order to remove specifically identified confidential information (other than study data) and/or delay the proposed publication to enable the sponsor to seek patent protection for inventions. The PI may not publish its results until 18 mos. after the trial has been completed at all sites.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Charles H. Davis
Organization: Sarah Cannon Research Institute
Phone: 615-524-4341
EMail: charles.davis2@scri-innovations.com
Publications:
Layout table for additonal information
Responsible Party: SCRI Development Innovations, LLC
ClinicalTrials.gov Identifier: NCT01626352     History of Changes
Other Study ID Numbers: SCRI LYM 75
First Submitted: June 20, 2012
First Posted: June 22, 2012
Results First Submitted: September 15, 2017
Results First Posted: October 18, 2017
Last Update Posted: November 22, 2017