Trial Outcomes & Findings for 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) (NCT NCT01108341)
NCT ID: NCT01108341
Last Updated: 2012-08-28
Results Overview
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.
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
50 participants
Primary outcome timeframe
up to Week 32
Results posted on
2012-08-28
Participant Flow
Participant milestones
| Measure |
Bendamustine and Ofatumumab
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 Study
STARTED
|
50
|
|
Overall Study
Safety Set (Enrolled and Treated)
|
49
|
|
Overall Study
COMPLETED
|
45
|
|
Overall Study
NOT COMPLETED
|
5
|
Reasons for withdrawal
| Measure |
Bendamustine and Ofatumumab
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 Study
Death
|
2
|
|
Overall Study
Withdrawal by Subject
|
1
|
|
Overall Study
Lost to Follow-up
|
1
|
|
Overall Study
Other
|
1
|
Baseline Characteristics
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)
Baseline characteristics by cohort
| Measure |
Bendamustine and Ofatumumab
n=49 Participants
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.
|
|---|---|
|
Age Continuous
|
59.1 years
STANDARD_DEVIATION 10.77 • n=5 Participants
|
|
Age, Customized
<65 years
|
31 participants
n=5 Participants
|
|
Age, Customized
>=65 years
|
18 participants
n=5 Participants
|
|
Sex: Female, Male
Female
|
23 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
26 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
3 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
45 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
1 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
American Indian or Alaska Native
|
1 participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Asian
|
2 participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Pacific Islander
|
0 participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Black
|
2 participants
n=5 Participants
|
|
Race/Ethnicity, Customized
White
|
44 participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Other
|
0 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: up to Week 32Population: Safety population of participants who were treated
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.
Outcome measures
| Measure |
Bendamustine and Ofatumumab
n=49 Participants
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.
|
|---|---|
|
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
|
90 percentage of participants
Interval 77.8 to 96.6
|
SECONDARY outcome
Timeframe: up to Week 32Population: Safety population of participants who were treated
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.
Outcome measures
| Measure |
Bendamustine and Ofatumumab
n=49 Participants
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.
|
|---|---|
|
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
|
67 percentage of participants
Interval 52.6 to 80.1
|
Adverse Events
Bendamustine and Ofatumumab
Serious events: 14 serious events
Other events: 49 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Bendamustine and Ofatumumab
n=49 participants at risk
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.
|
|---|---|
|
Blood and lymphatic system disorders
Febrile neutropenia
|
4.1%
2/49 • up to 39 weeks
|
|
Eye disorders
Diplopia
|
2.0%
1/49 • up to 39 weeks
|
|
Gastrointestinal disorders
Ascites
|
2.0%
1/49 • up to 39 weeks
|
|
Gastrointestinal disorders
Colitis
|
2.0%
1/49 • up to 39 weeks
|
|
Gastrointestinal disorders
Diarrhoea
|
2.0%
1/49 • up to 39 weeks
|
|
Gastrointestinal disorders
Faeces discoloured
|
2.0%
1/49 • up to 39 weeks
|
|
Gastrointestinal disorders
Nausea
|
2.0%
1/49 • up to 39 weeks
|
|
General disorders
Infusion related reaction
|
4.1%
2/49 • up to 39 weeks
|
|
General disorders
Pyrexia
|
4.1%
2/49 • up to 39 weeks
|
|
General disorders
Asthenia
|
2.0%
1/49 • up to 39 weeks
|
|
General disorders
Device dislocation
|
2.0%
1/49 • up to 39 weeks
|
|
General disorders
Fatigue
|
2.0%
1/49 • up to 39 weeks
|
|
Hepatobiliary disorders
Portal vein thrombosis
|
2.0%
1/49 • up to 39 weeks
|
|
Infections and infestations
Bacterial sepsis
|
2.0%
1/49 • up to 39 weeks
|
|
Infections and infestations
Device related sepsis
|
2.0%
1/49 • up to 39 weeks
|
|
Infections and infestations
Gastroenteritis
|
2.0%
1/49 • up to 39 weeks
|
|
Infections and infestations
Pneumonia
|
2.0%
1/49 • up to 39 weeks
|
|
Infections and infestations
Sepsis
|
2.0%
1/49 • up to 39 weeks
|
|
Infections and infestations
Tooth abscess
|
2.0%
1/49 • up to 39 weeks
|
|
Investigations
Oxygen saturation decreased
|
2.0%
1/49 • up to 39 weeks
|
|
Metabolism and nutrition disorders
Dehydration
|
2.0%
1/49 • up to 39 weeks
|
|
Metabolism and nutrition disorders
Failure to thrive
|
2.0%
1/49 • up to 39 weeks
|
|
Metabolism and nutrition disorders
Hypercalcaemia
|
2.0%
1/49 • up to 39 weeks
|
|
Metabolism and nutrition disorders
Hyperkalaemia
|
2.0%
1/49 • up to 39 weeks
|
|
Metabolism and nutrition disorders
Hypophagia
|
2.0%
1/49 • up to 39 weeks
|
|
Musculoskeletal and connective tissue disorders
Muscular weakness
|
2.0%
1/49 • up to 39 weeks
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Non-small cell lung cancer
|
2.0%
1/49 • up to 39 weeks
|
|
Nervous system disorders
Depressed level of consciousness
|
2.0%
1/49 • up to 39 weeks
|
|
Renal and urinary disorders
Renal failure acute
|
2.0%
1/49 • up to 39 weeks
|
|
Respiratory, thoracic and mediastinal disorders
Bronchospasm
|
2.0%
1/49 • up to 39 weeks
|
|
Respiratory, thoracic and mediastinal disorders
Sinus congestion
|
2.0%
1/49 • up to 39 weeks
|
|
Skin and subcutaneous tissue disorders
Hyperhidrosis
|
2.0%
1/49 • up to 39 weeks
|
|
Skin and subcutaneous tissue disorders
Rash
|
2.0%
1/49 • up to 39 weeks
|
|
Vascular disorders
Hot flush
|
2.0%
1/49 • up to 39 weeks
|
Other adverse events
| Measure |
Bendamustine and Ofatumumab
n=49 participants at risk
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.
|
|---|---|
|
Blood and lymphatic system disorders
Neutropenia
|
20.4%
10/49 • up to 39 weeks
|
|
Blood and lymphatic system disorders
Leukopenia
|
14.3%
7/49 • up to 39 weeks
|
|
Blood and lymphatic system disorders
Anaemia
|
10.2%
5/49 • up to 39 weeks
|
|
Blood and lymphatic system disorders
Thrombocytopenia
|
8.2%
4/49 • up to 39 weeks
|
|
Blood and lymphatic system disorders
Lymphopenia
|
6.1%
3/49 • up to 39 weeks
|
|
Cardiac disorders
Tachycardia
|
10.2%
5/49 • up to 39 weeks
|
|
Cardiac disorders
Palpitations
|
6.1%
3/49 • up to 39 weeks
|
|
Eye disorders
Eye irritation
|
8.2%
4/49 • up to 39 weeks
|
|
Gastrointestinal disorders
Nausea
|
59.2%
29/49 • up to 39 weeks
|
|
Gastrointestinal disorders
Constipation
|
34.7%
17/49 • up to 39 weeks
|
|
Gastrointestinal disorders
Diarrhoea
|
24.5%
12/49 • up to 39 weeks
|
|
Gastrointestinal disorders
Vomiting
|
24.5%
12/49 • up to 39 weeks
|
|
Gastrointestinal disorders
Abdominal pain
|
10.2%
5/49 • up to 39 weeks
|
|
Gastrointestinal disorders
Gastrooesophageal reflux disease
|
8.2%
4/49 • up to 39 weeks
|
|
Gastrointestinal disorders
Stomatitis
|
8.2%
4/49 • up to 39 weeks
|
|
Gastrointestinal disorders
Dyspepsia
|
6.1%
3/49 • up to 39 weeks
|
|
General disorders
Fatigue
|
53.1%
26/49 • up to 39 weeks
|
|
General disorders
Infusion related reaction
|
40.8%
20/49 • up to 39 weeks
|
|
General disorders
Oedema peripheral
|
20.4%
10/49 • up to 39 weeks
|
|
General disorders
Pyrexia
|
12.2%
6/49 • up to 39 weeks
|
|
General disorders
Chills
|
12.2%
6/49 • up to 39 weeks
|
|
General disorders
Asthenia
|
8.2%
4/49 • up to 39 weeks
|
|
Immune system disorders
Drug hypersensitivity
|
10.2%
5/49 • up to 39 weeks
|
|
Infections and infestations
Sinusitis
|
8.2%
4/49 • up to 39 weeks
|
|
Infections and infestations
Upper respiratory tract infection
|
8.2%
4/49 • up to 39 weeks
|
|
Investigations
White blood cell count decreased
|
26.5%
13/49 • up to 39 weeks
|
|
Investigations
Neutrophil count decreased
|
22.4%
11/49 • up to 39 weeks
|
|
Investigations
Platelet count decreased
|
14.3%
7/49 • up to 39 weeks
|
|
Investigations
Weight decreased
|
8.2%
4/49 • up to 39 weeks
|
|
Investigations
Haemoglobin decreased
|
6.1%
3/49 • up to 39 weeks
|
|
Metabolism and nutrition disorders
Decreased appetite
|
14.3%
7/49 • up to 39 weeks
|
|
Metabolism and nutrition disorders
Hypokalaemia
|
6.1%
3/49 • up to 39 weeks
|
|
Metabolism and nutrition disorders
Hypomagnesaemia
|
6.1%
3/49 • up to 39 weeks
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
14.3%
7/49 • up to 39 weeks
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
12.2%
6/49 • up to 39 weeks
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
6.1%
3/49 • up to 39 weeks
|
|
Nervous system disorders
Headache
|
24.5%
12/49 • up to 39 weeks
|
|
Nervous system disorders
Dizziness
|
20.4%
10/49 • up to 39 weeks
|
|
Nervous system disorders
Dysgeusia
|
8.2%
4/49 • up to 39 weeks
|
|
Psychiatric disorders
Insomnia
|
14.3%
7/49 • up to 39 weeks
|
|
Psychiatric disorders
Anxiety
|
8.2%
4/49 • up to 39 weeks
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
26.5%
13/49 • up to 39 weeks
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
16.3%
8/49 • up to 39 weeks
|
|
Respiratory, thoracic and mediastinal disorders
Nasal congestion
|
8.2%
4/49 • up to 39 weeks
|
|
Respiratory, thoracic and mediastinal disorders
Rhinitis allergic
|
6.1%
3/49 • up to 39 weeks
|
|
Skin and subcutaneous tissue disorders
Rash
|
18.4%
9/49 • up to 39 weeks
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
16.3%
8/49 • up to 39 weeks
|
|
Skin and subcutaneous tissue disorders
Urticaria
|
16.3%
8/49 • up to 39 weeks
|
|
Skin and subcutaneous tissue disorders
Periorbital oedema
|
6.1%
3/49 • up to 39 weeks
|
|
Vascular disorders
Hypertension
|
10.2%
5/49 • up to 39 weeks
|
|
Vascular disorders
Hypotension
|
6.1%
3/49 • up to 39 weeks
|
Additional Information
Director, Clinical Research
Teva Branded Pharmaceutical Products, R&D Inc.
Phone: 215-591-3000
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee 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.
- Publication restrictions are in place
Restriction type: OTHER