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Trial record 100 of 314 for:    BENDAMUSTINE

Ofatumumab and Bendamustine Followed by Maintenance Ofatumumab for Rituximab Relapsed Indolent B-cell Non-Hodgkin's Lymphoma (B-NHL)

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ClinicalTrials.gov Identifier: NCT01294579
Recruitment Status : Completed
First Posted : February 11, 2011
Results First Posted : August 9, 2018
Last Update Posted : August 9, 2018
Sponsor:
Information provided by (Responsible Party):
Novartis ( Novartis Pharmaceuticals )

Study Type Interventional
Study Design Masking: None (Open Label);   Primary Purpose: Treatment
Condition Lymphoma, Non-Hodgkin
Interventions Biological: Ofatumumab
Drug: Bendamustine
Enrollment 49
Recruitment Details  
Pre-assignment Details Subjects completed represents subjects who completed treatment.
Arm/Group Title Ofatumumab and Bendamustine
Hide Arm/Group Description 1000 mg intravenous (IV) on day 1 of each cycle (cycles 1-6) for induction phase and 1000 mg IV every 2 months for 2 years. Bendamustine 90 mg/m2 was given on day 1 (after the ofatumumab infusion) and day 2 of each cycle (cycles 1-6)
Period Title: Overall Study
Started 49
Completed 14
Not Completed 35
Reason Not Completed
Disease progression             12
Adverse Event             11
Study closed/terminated             3
Lost to Follow-up             1
Physician Decision             3
Withdrawal by Subject             5
Arm/Group Title Ofatumumab and Bendamustine
Hide Arm/Group Description 1000 mg intravenous (IV) on day 1 of each cycle (cycles 1-6) for induction phase and 1000 mg IV every 2 months for 2 years. Bendamustine 90 mg/m2 was given on day 1 (after the ofatumumab infusion) and day 2 of each cycle (cycles 1-6)
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
66.3  (11.61)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 49 participants
Female
14
  28.6%
Male
35
  71.4%
Race/Ethnicity, Customized  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 49 participants
African American/African heritage
3
   6.1%
White
45
  91.8%
Mixed race
1
   2.0%
1.Primary Outcome
Title Complete Remission (CR) Rate of Induction Therapy After Cycle 6 (28 Days) (FAS)
Hide Description Complete response (CR) included all of the following: complete disappearance of all detectable clinical evidence of disease and disease-related symptoms if present before therapy. All target nodes had to have regressed to ≤ 1.5cm in the longest diameter. Non-measureable nodes 1.1 to 1.5cm in the longest diameter and >1cm in the short axis at baseline had to regress to ≤ 1cm in the short axis by visual estimation; enlarged spleen or liver (with nodules) must have returned to normal size and nodules disappeared and if bone marrow was involved, infiltrate had to have cleared on repeat biopsy sample. CR was not valid without imaging data. The corresponding 2-sided 95% exact confidence interval (CI) of the response rate was estimated by the Clopper-Pearson method.
Time Frame Baseline up to 24 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Ofatumumab and Bendamustine
Hide Arm/Group Description:
1000 mg intravenous (IV) on day 1 of each cycle (cycles 1-6) for induction phase and 1000 mg IV every 2 months for 2 years. Bendamustine 90 mg/m2 was given on day 1 (after the ofatumumab infusion) and day 2 of each cycle (cycles 1-6)
Overall Number of Participants Analyzed 49
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: percentage of participants
24.5
(13.3 to 38.9)
2.Secondary Outcome
Title Overall Response Rate (ORR) During Induction Phase After Cycle 6 (FAS)
Hide Description The overall response = CR (defined in Primary Outcome) + Partial Response (PR) which required all of the following: > or = to 50% decrease from baseline in target nodules; > or = to 50% decrease in hepatic/splenic nodules and no increase in liver or spleen size; no unequivocal progression in non-target lestions; no new sites of disease.
Time Frame Baseline up to 24 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Ofatumumab and Bendamustine
Hide Arm/Group Description:
1000 mg intravenous (IV) on day 1 of each cycle (cycles 1-6) for induction phase and 1000 mg IV every 2 months for 2 years. Bendamustine 90 mg/m2 was given on day 1 (after the ofatumumab infusion) and day 2 of each cycle (cycles 1-6)
Overall Number of Participants Analyzed 49
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: percentage of participants
67.3
(52.5 to 80.1)
3.Secondary Outcome
Title Conversion Rate of Partial Response in Induction Phase to Complete Response With Maintenance Ofatumumab (FAS)
Hide Description Rate of conversion from PR in the Induction phase, to CR with maintenance ofatumumab in subjects who have a PR with induction therapy with ofatumumab and bendamustine
Time Frame Partial response in induction phase up to 24 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Ofatumumab and Bendamustine
Hide Arm/Group Description:
1000 mg intravenous (IV) on day 1 of each cycle (cycles 1-6) for induction phase and 1000 mg IV every 2 months for 2 years. Bendamustine 90 mg/m2 was given on day 1 (after the ofatumumab infusion) and day 2 of each cycle (cycles 1-6)
Overall Number of Participants Analyzed 16
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: percentage of participants
37.5
(15.2 to 64.6)
4.Secondary Outcome
Title Percentage of Participants With Progression Free Survival (PFS) up to 30 Months (FAS)
Hide Description Progression free survival (PFS) is defined as the interval between first treatment and disease progression or death due to any cause. PFS criteria: A previously normal node (≤ 1.5 x ≤ 1.0cm), including nodes that were not previously visible, must increase to >2.0 x ≥ 1.5cm; ≥ 50% increase from nadir in the PPD of any target node. The long axis must increase by at least 5 mm and to >2.0cm.; ≥ 50% increase from nadir in the long axis of any target node. The long axis must increase by at least 5 mm and to >2.0 cm.; ≥ 50% increase from nadir in the SPD of target nodes and at least one node should have a long axis >1.5 cm.
Time Frame Baseline up to approximately 30 months
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Ofatumumab and Bendamustine
Hide Arm/Group Description:
1000 mg intravenous (IV) on day 1 of each cycle (cycles 1-6) for induction phase and 1000 mg IV every 2 months for 2 years. Bendamustine 90 mg/m2 was given on day 1 (after the ofatumumab infusion) and day 2 of each cycle (cycles 1-6)
Overall Number of Participants Analyzed 49
Measure Type: Number
Unit of Measure: percentage of participants
PFS events 42.9
PFS events - Progression 32.7
PFS events - Death 10.2
censored - follow-up ended 57.1
5.Secondary Outcome
Title Kaplan-Meier Estimates of Progression Free Survival up to 30 Months (FAS)
Hide Description Progression Free Survival (PFS) is defined as the interval between first treatment and disease progression or death due to any cause. PFS events: progression documented between scheduled visits, death before first PD assessment (or death at baseline or prior to any adequate assessments), death between adequate assessment visits. For the PFS analysis, the survival function was estimated using Kaplan-Meier estimates.
Time Frame Baseline up to approximately 30 months
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Ofatumumab and Bendamustine
Hide Arm/Group Description:
1000 mg intravenous (IV) on day 1 of each cycle (cycles 1-6) for induction phase and 1000 mg IV every 2 months for 2 years. Bendamustine 90 mg/m2 was given on day 1 (after the ofatumumab infusion) and day 2 of each cycle (cycles 1-6)
Overall Number of Participants Analyzed 49
Median (95% Confidence Interval)
Unit of Measure: months
29.7 [1] 
(17.3 to NA)
[1]
Upper limit of CI was not estimable
6.Secondary Outcome
Title Pharmacokinetic Profile Which Includes Measuring Blood Levels of Ofatumumab and Bendamustine in Combination and Ofatumumab Alone During Maintenance Treatment and Measuring Blood Levels of Circulating B Cell
Hide Description Due to recruitment issues, this data analysis was not done per changes in planned analysis. This data was only presented as patient listings. The statistical analysis plan was modified to indicate that Pharmacokinetic/Pharmacodynamic exploratory analyses were not done.
Time Frame up to 30 months
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Ofatumumab and Bendamustine
Hide Arm/Group Description:
1000 mg intravenous (IV) on day 1 of each cycle (cycles 1-6) for induction phase and 1000 mg IV every 2 months for 2 years. Bendamustine 90 mg/m2 was given on day 1 (after the ofatumumab infusion) and day 2 of each cycle (cycles 1-6)
Overall Number of Participants Analyzed 0
No data displayed because Outcome Measure has zero total analyzed.
7.Secondary Outcome
Title All Deaths by Preferred Term (Safety Set) up to Approximately 30 Months
Hide Description Deaths were collected and were considered to be an on treatment death up to 60 days post treatment.
Time Frame Baseline up to approximately 30 months
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Ofatumumab and Bendamustine
Hide Arm/Group Description:
1000 mg intravenous (IV) on day 1 of each cycle (cycles 1-6) for induction phase and 1000 mg IV every 2 months for 2 years. Bendamustine 90 mg/m2 was given on day 1 (after the ofatumumab infusion) and day 2 of each cycle (cycles 1-6)
Overall Number of Participants Analyzed 49
Measure Type: Number
Unit of Measure: participants
Disease progression 3
Pneumonia 1
Myelodysplastic syndrome -reported post study 1
Squamous cell carcinoma of lung 1
Chronic obstructive pulmonary disease 1
Time Frame Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit up to approximately 30 months
Adverse Event Reporting Description Deaths are reported as a secondary outcome
 
Arm/Group Title Ofatumumab + Bendamustine
Hide Arm/Group Description Ofatumumab + Bendamustine
All-Cause Mortality
Ofatumumab + Bendamustine
Affected / at Risk (%)
Total   7/49 (14.29%) 
Show Serious Adverse Events Hide Serious Adverse Events
Ofatumumab + Bendamustine
Affected / at Risk (%)
Total   18/49 (36.73%) 
Blood and lymphatic system disorders   
Febrile neutropenia  1  2/49 (4.08%) 
Pancytopenia  1  1/49 (2.04%) 
Gastrointestinal disorders   
Gastric ulcer  1  1/49 (2.04%) 
General disorders   
Fatigue  1  2/49 (4.08%) 
Pyrexia  1  3/49 (6.12%) 
Immune system disorders   
Anaphylactic reaction  1  1/49 (2.04%) 
Infections and infestations   
Diverticulitis  1  1/49 (2.04%) 
Infected skin ulcer  1  1/49 (2.04%) 
Neutropenic sepsis  1  1/49 (2.04%) 
Pneumonia  1  3/49 (6.12%) 
Upper respiratory tract infection  1  1/49 (2.04%) 
Urinary tract infection  1  1/49 (2.04%) 
Investigations   
Electrocardiogram QT prolonged  1  1/49 (2.04%) 
Metabolism and nutrition disorders   
Failure to thrive  1  1/49 (2.04%) 
Musculoskeletal and connective tissue disorders   
Rhabdomyolysis  1  1/49 (2.04%) 
Neoplasms benign, malignant and unspecified (incl cysts and polyps)   
Myelodysplastic syndrome  1  3/49 (6.12%) 
Prostate cancer  1  1/49 (2.04%) 
Squamous cell carcinoma of lung  1  1/49 (2.04%) 
Squamous cell carcinoma of skin  1  1/49 (2.04%) 
Nervous system disorders   
Syncope  1  1/49 (2.04%) 
Respiratory, thoracic and mediastinal disorders   
Chronic obstructive pulmonary disease  1  1/49 (2.04%) 
Pneumonitis  1  1/49 (2.04%) 
1
Term from vocabulary, MedDRA (19.0)
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%
Ofatumumab + Bendamustine
Affected / at Risk (%)
Total   47/49 (95.92%) 
Blood and lymphatic system disorders   
Anaemia  1  10/49 (20.41%) 
Leukopenia  1  6/49 (12.24%) 
Lymphopenia  1  3/49 (6.12%) 
Neutropenia  1  11/49 (22.45%) 
Thrombocytopenia  1  7/49 (14.29%) 
Ear and labyrinth disorders   
External ear pain  1  3/49 (6.12%) 
Gastrointestinal disorders   
Abdominal pain  1  5/49 (10.20%) 
Constipation  1  14/49 (28.57%) 
Diarrhoea  1  13/49 (26.53%) 
Nausea  1  24/49 (48.98%) 
Vomiting  1  10/49 (20.41%) 
General disorders   
Asthenia  1  10/49 (20.41%) 
Chest discomfort  1  3/49 (6.12%) 
Chills  1  4/49 (8.16%) 
Fatigue  1  30/49 (61.22%) 
Mucosal inflammation  1  3/49 (6.12%) 
Oedema peripheral  1  5/49 (10.20%) 
Pain  1  3/49 (6.12%) 
Pyrexia  1  8/49 (16.33%) 
Infections and infestations   
Sinusitis  1  6/49 (12.24%) 
Upper respiratory tract infection  1  8/49 (16.33%) 
Urinary tract infection  1  4/49 (8.16%) 
Injury, poisoning and procedural complications   
Contusion  1  3/49 (6.12%) 
Infusion related reaction  1  12/49 (24.49%) 
Investigations   
Blood creatinine increased  1  4/49 (8.16%) 
Lymphocyte count decreased  1  5/49 (10.20%) 
Neutrophil count decreased  1  5/49 (10.20%) 
Weight decreased  1  6/49 (12.24%) 
White blood cell count decreased  1  5/49 (10.20%) 
Metabolism and nutrition disorders   
Decreased appetite  1  8/49 (16.33%) 
Dehydration  1  6/49 (12.24%) 
Hyperuricaemia  1  3/49 (6.12%) 
Vitamin D deficiency  1  4/49 (8.16%) 
Musculoskeletal and connective tissue disorders   
Arthralgia  1  6/49 (12.24%) 
Back pain  1  6/49 (12.24%) 
Bone pain  1  5/49 (10.20%) 
Muscle spasms  1  4/49 (8.16%) 
Muscular weakness  1  3/49 (6.12%) 
Myalgia  1  6/49 (12.24%) 
Pain in extremity  1  4/49 (8.16%) 
Nervous system disorders   
Dizziness  1  9/49 (18.37%) 
Dysgeusia  1  4/49 (8.16%) 
Headache  1  6/49 (12.24%) 
Neuropathy peripheral  1  3/49 (6.12%) 
Psychiatric disorders   
Insomnia  1  7/49 (14.29%) 
Renal and urinary disorders   
Pollakiuria  1  4/49 (8.16%) 
Respiratory, thoracic and mediastinal disorders   
Cough  1  8/49 (16.33%) 
Dyspnoea  1  12/49 (24.49%) 
Oropharyngeal pain  1  4/49 (8.16%) 
Throat irritation  1  7/49 (14.29%) 
Skin and subcutaneous tissue disorders   
Night sweats  1  3/49 (6.12%) 
Pruritus  1  12/49 (24.49%) 
Rash  1  11/49 (22.45%) 
Urticaria  1  10/49 (20.41%) 
Vascular disorders   
Flushing  1  5/49 (10.20%) 
Hypertension  1  4/49 (8.16%) 
Hypotension  1  4/49 (8.16%) 
1
Term from vocabulary, MedDRA (19.0)
Indicates events were collected by systematic assessment
The study was terminated early based on the evolution of the current therapeutic treatment landscape in Non Hodgkin Indolent Lymphomas and low enrollment rates for this trial.
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 terms and conditions of Novartis' agreements with its investigators may vary. However, Novartis does not prohibit any investigator from publishing. Any publications from a single-site are postponed until the publication of the pooled data (ie, data from all sites) in the clinical trial.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Study Director
Organization: Novartis Pharmaceuticals
Phone: 862-778-8300
EMail: Novartis.email@novartis.com
Layout table for additonal information
Responsible Party: Novartis ( Novartis Pharmaceuticals )
ClinicalTrials.gov Identifier: NCT01294579     History of Changes
Other Study ID Numbers: 114612
First Submitted: February 3, 2011
First Posted: February 11, 2011
Results First Submitted: December 15, 2017
Results First Posted: August 9, 2018
Last Update Posted: August 9, 2018