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Ofatumumab in Treating Patients With Previously Untreated Stage II, Stage III, or Stage IV Follicular Non-Hodgkin Lymphoma

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: NCT01190449
Recruitment Status : Active, not recruiting
First Posted : August 27, 2010
Results First Posted : July 26, 2018
Last Update Posted : July 10, 2019
Sponsor:
Collaborator:
National Cancer Institute (NCI)
Information provided by (Responsible Party):
Alliance for Clinical Trials in Oncology

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition Lymphoma
Intervention Biological: ofatumumab
Enrollment 51
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Arm I (Low-dose Ofatumumab) Arm II (High-dose Ofatumumab)
Hide Arm/Group Description Patients receive a lower dose (500 mg) of ofatumumab IV over 2-8 hours on days 1, 8, 15, and 22 and then once every 8 weeks in months 3-9 (weeks 12, 20, 28, and 36). Patients receive a high-dose (1000 mg) of ofatumumab IV over 2-8 hours on days 1, 8, 15, and 22 and then once every 8 weeks in months 3-9 (weeks 12, 20, 28, and 36).
Period Title: Overall Study
Started 15 36
Completed 15 32
Not Completed 0 4
Reason Not Completed
Ineligible             0             4
Arm/Group Title Arm I (Low-dose Ofatumumab) Arm II (High-dose Ofatumumab) Total
Hide Arm/Group Description Patients receive a lower dose (500 mg) of ofatumumab IV over 2-8 hours on days 1, 8, 15, and 22 and then once every 8 weeks in months 3-9 (weeks 12, 20, 28, and 36). Patients receive a high-dose (1000 mg) of ofatumumab IV over 2-8 hours on days 1, 8, 15, and 22 and then once every 8 weeks in months 3-9 (weeks 12, 20, 28, and 36). Total of all reporting groups
Overall Number of Baseline Participants 15 36 51
Hide Baseline Analysis Population Description
Baseline characteristics summarized overall for all patients who enrolled in the study.
Age, Continuous  
Median (Full Range)
Unit of measure:  Years
Number Analyzed 15 participants 36 participants 51 participants
63
(43 to 85)
58
(40 to 85)
60
(40 to 85)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 15 participants 36 participants 51 participants
Female
4
  26.7%
19
  52.8%
23
  45.1%
Male
11
  73.3%
17
  47.2%
28
  54.9%
Region of Enrollment  
Measure Type: Count of Participants
Unit of measure:  Participants
United States Number Analyzed 15 participants 36 participants 51 participants
15
 100.0%
36
 100.0%
51
 100.0%
1.Primary Outcome
Title Overall Response Rate (Complete or Partial Response) by Month 12
Hide Description The primary endpoint of this trial is overall response rate (OR=complete response (CR) or partial response (PR)) to 500 mg or 1000 mg dose of ofatumumab in previously untreated patients with CD20+ follicular NHL. The response outcome is defined as the best response during the 12 months of first-line and extended induction treatment. A CR is defined as complete disappearance of all detectable clinical evidence of disease and disease-related symptoms if present before therapy. A PR is defined as at least a 50% decrease in the sum of the product of the diameters (SPD) of up to six of the largest dominant nodes or nodal masses, with no increase observed in the size of other nodes, liver, or spleen and no new sites of disease should be observed. The ORR (percentage of patients) reported below by arm is the percentage of patients whose best response during the 12 months of treatment was CR or PR.
Time Frame From baseline to month 12
Hide Outcome Measure Data
Hide Analysis Population Description
Patients who completed the study and were not ineligible were included in this analysis.
Arm/Group Title Arm I (Low-dose Ofatumumab) Arm II (High-dose Ofatumumab)
Hide Arm/Group Description:
Patients receive a lower dose (500 mg) of ofatumumab IV over 2-8 hours on days 1, 8, 15, and 22 and then once every 8 weeks in months 3-9 (weeks 12, 20, 28, and 36).
Patients receive a high-dose (1000 mg) of ofatumumab IV over 2-8 hours on days 1, 8, 15, and 22 and then once every 8 weeks in months 3-9 (weeks 12, 20, 28, and 36).
Overall Number of Participants Analyzed 15 32
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: percentage of patients
60
(32 to 84)
84
(67 to 95)
2.Secondary Outcome
Title Median Progression-free Survival Time
Hide Description The median progression-free survival (PFS) time for each arm was estimated using the Kaplan-Meier method. PFS was calculated as the time from study entry until progression or death, whichever occurred first. Patients were censored at the time last known alive and progression free. Lymph nodes should be considered abnormal if the long axis is > 1.5 cm, regardless of the short axis. If a lymph node has a long axis of 1.1 to 1.5 cm, it should only be considered abnormal if its short axis is > 1.0. Lymph nodes ≤ 1.0 cm by ≤ 1.0 cm will not be considered as abnormal for relapse or progressive disease. Progression is defined using the 2007 revised response criteria reported by Cheson et al. as follows: Appearance of any new lesion, At least a 50% increase from nadir in the SPD of any previously involved nodes, At least a 50% increase in the longest diameter of any single previously identified node > 1.0 cm in its short axis.
Time Frame From date of study entry until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 4 years
Hide Outcome Measure Data
Hide Analysis Population Description
Patients who completed the study and were not ineligible were included in this analysis.
Arm/Group Title Arm I (Low-dose Ofatumumab) Arm II (High-dose Ofatumumab)
Hide Arm/Group Description:
Patients receive a lower dose (500 mg) of ofatumumab IV over 2-8 hours on days 1, 8, 15, and 22 and then once every 8 weeks in months 3-9 (weeks 12, 20, 28, and 36).
Patients receive a high-dose (1000 mg) of ofatumumab IV over 2-8 hours on days 1, 8, 15, and 22 and then once every 8 weeks in months 3-9 (weeks 12, 20, 28, and 36).
Overall Number of Participants Analyzed 15 32
Median (95% Confidence Interval)
Unit of Measure: years
1.9
(1.0 to 1.9)
1.9
(1.5 to 3.0)
Time Frame From baseline to month 12
Adverse Event Reporting Description Each CTCAE term is a unique representation of a specific event used for medical documentation and scientific analysis and is a single MedDRA Lowest Level Term (LLT). All graded AEs are reported for patients who completed the study. Serious AE (SAE) reports may include any secondary serious or non-serious events considered related to the primary event (the reason for filing an expedited report); collectively, these events are referred to as Expedited AEs, and appear in the SAE table.
 
Arm/Group Title Arm I (Low-dose Ofatumumab) Arm II (High-dose Ofatumumab)
Hide Arm/Group Description Patients receive a lower dose (500 mg) of ofatumumab IV over 2-8 hours on days 1, 8, 15, and 22 and then once every 8 weeks in months 3-9 (weeks 12, 20, 28, and 36). Patients receive a high-dose (1000 mg) of ofatumumab IV over 2-8 hours on days 1, 8, 15, and 22 and then once every 8 weeks in months 3-9 (weeks 12, 20, 28, and 36).
All-Cause Mortality
Arm I (Low-dose Ofatumumab) Arm II (High-dose Ofatumumab)
Affected / at Risk (%) Affected / at Risk (%)
Total   0/15 (0.00%)      0/36 (0.00%)    
Hide Serious Adverse Events
Arm I (Low-dose Ofatumumab) Arm II (High-dose Ofatumumab)
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   2/15 (13.33%)      8/36 (22.22%)    
Cardiac disorders     
Acute coronary syndrome  1  0/15 (0.00%)  0 1/36 (2.78%)  1
Gastrointestinal disorders     
Small intestinal obstruction  1  0/15 (0.00%)  0 1/36 (2.78%)  1
General disorders     
Fatigue  1  0/15 (0.00%)  0 1/36 (2.78%)  1
Infusion related reaction  1  0/15 (0.00%)  0 3/36 (8.33%)  3
Infections and infestations     
Bone infection  1  1/15 (6.67%)  1 0/36 (0.00%)  0
Infections and infestations - Other, specify  1  1/15 (6.67%)  1 0/36 (0.00%)  0
Investigations     
Lymphocyte count decreased  1  1/15 (6.67%)  1 2/36 (5.56%)  2
White blood cell decreased  1  0/15 (0.00%)  0 1/36 (2.78%)  1
Respiratory, thoracic and mediastinal disorders     
Pneumonitis  1  0/15 (0.00%)  0 1/36 (2.78%)  1
1
Term from vocabulary, MedDRA 12
Indicates events were collected by systematic assessment
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Arm I (Low-dose Ofatumumab) Arm II (High-dose Ofatumumab)
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   15/15 (100.00%)      35/36 (97.22%)    
Blood and lymphatic system disorders     
Anemia  1  2/15 (13.33%)  5 6/36 (16.67%)  23
Leukocytosis  1  1/15 (6.67%)  1 0/36 (0.00%)  0
Lymph node pain  1  1/15 (6.67%)  1 1/36 (2.78%)  1
Cardiac disorders     
Aortic valve disease  1  1/15 (6.67%)  4 0/36 (0.00%)  0
Cardiac disorders - Other, specify  1  0/15 (0.00%)  0 1/36 (2.78%)  4
Palpitations  1  0/15 (0.00%)  0 1/36 (2.78%)  1
Sinus bradycardia  1  0/15 (0.00%)  0 1/36 (2.78%)  1
Ear and labyrinth disorders     
Ear pain  1  0/15 (0.00%)  0 1/36 (2.78%)  1
Hearing impaired  1  0/15 (0.00%)  0 1/36 (2.78%)  1
Tinnitus  1  1/15 (6.67%)  2 0/36 (0.00%)  0
Vertigo  1  0/15 (0.00%)  0 1/36 (2.78%)  1
Eye disorders     
Blurred vision  1  1/15 (6.67%)  1 0/36 (0.00%)  0
Eye disorders - Other, specify  1  0/15 (0.00%)  0 1/36 (2.78%)  1
Gastrointestinal disorders     
Abdominal pain  1  1/15 (6.67%)  1 7/36 (19.44%)  20
Bloating  1  0/15 (0.00%)  0 1/36 (2.78%)  3
Constipation  1  1/15 (6.67%)  1 4/36 (11.11%)  7
Dental caries  1  0/15 (0.00%)  0 2/36 (5.56%)  8
Diarrhea  1  2/15 (13.33%)  2 7/36 (19.44%)  18
Dyspepsia  1  0/15 (0.00%)  0 6/36 (16.67%)  18
Flatulence  1  1/15 (6.67%)  4 0/36 (0.00%)  0
Gastritis  1  0/15 (0.00%)  0 1/36 (2.78%)  1
Gastroesophageal reflux disease  1  1/15 (6.67%)  1 4/36 (11.11%)  7
Mucositis oral  1  1/15 (6.67%)  2 0/36 (0.00%)  0
Nausea  1  3/15 (20.00%)  8 13/36 (36.11%)  29
Rectal hemorrhage  1  0/15 (0.00%)  0 1/36 (2.78%)  1
Vomiting  1  0/15 (0.00%)  0 2/36 (5.56%)  2
General disorders     
Chills  1  1/15 (6.67%)  1 4/36 (11.11%)  11
Edema limbs  1  1/15 (6.67%)  2 3/36 (8.33%)  10
Edema trunk  1  1/15 (6.67%)  1 0/36 (0.00%)  0
Fatigue  1  11/15 (73.33%)  32 23/36 (63.89%)  75
Fever  1  1/15 (6.67%)  1 4/36 (11.11%)  5
Flu like symptoms  1  0/15 (0.00%)  0 1/36 (2.78%)  1
General disorders and administration site conditions - Other, specify  1  0/15 (0.00%)  0 2/36 (5.56%)  2
Infusion related reaction  1  13/15 (86.67%)  19 29/36 (80.56%)  33
Malaise  1  0/15 (0.00%)  0 1/36 (2.78%)  1
Neck edema  1  0/15 (0.00%)  0 1/36 (2.78%)  1
Non-cardiac chest pain  1  0/15 (0.00%)  0 1/36 (2.78%)  1
Pain  1  1/15 (6.67%)  2 4/36 (11.11%)  9
Immune system disorders     
Allergic reaction  1  1/15 (6.67%)  3 1/36 (2.78%)  2
Cytokine release syndrome  1  1/15 (6.67%)  1 2/36 (5.56%)  2
Infections and infestations     
Bronchial infection  1  1/15 (6.67%)  1 2/36 (5.56%)  3
Infections and infestations - Other, specify  1  2/15 (13.33%)  2 2/36 (5.56%)  2
Sinusitis  1  0/15 (0.00%)  0 1/36 (2.78%)  1
Skin infection  1  0/15 (0.00%)  0 1/36 (2.78%)  1
Upper respiratory infection  1  0/15 (0.00%)  0 4/36 (11.11%)  4
Urinary tract infection  1  1/15 (6.67%)  1 4/36 (11.11%)  4
Vaginal infection  1  0/15 (0.00%)  0 1/36 (2.78%)  1
Injury, poisoning and procedural complications     
Bruising  1  0/15 (0.00%)  0 2/36 (5.56%)  2
Fall  1  2/15 (13.33%)  2 0/36 (0.00%)  0
Injury, poisoning and procedural complications - Other, specify  1  0/15 (0.00%)  0 1/36 (2.78%)  1
Investigations     
Alanine aminotransferase increased  1  0/15 (0.00%)  0 5/36 (13.89%)  7
Alkaline phosphatase increased  1  0/15 (0.00%)  0 1/36 (2.78%)  5
Aspartate aminotransferase increased  1  1/15 (6.67%)  1 2/36 (5.56%)  3
Blood bilirubin increased  1  0/15 (0.00%)  0 3/36 (8.33%)  11
Creatinine increased  1  1/15 (6.67%)  2 3/36 (8.33%)  5
Lymphocyte count decreased  1  3/15 (20.00%)  17 11/36 (30.56%)  41
Neutrophil count decreased  1  0/15 (0.00%)  0 6/36 (16.67%)  12
Platelet count decreased  1  2/15 (13.33%)  9 2/36 (5.56%)  11
Weight gain  1  1/15 (6.67%)  2 3/36 (8.33%)  7
Weight loss  1  0/15 (0.00%)  0 1/36 (2.78%)  1
White blood cell decreased  1  2/15 (13.33%)  5 10/36 (27.78%)  26
Metabolism and nutrition disorders     
Anorexia  1  3/15 (20.00%)  4 2/36 (5.56%)  3
Dehydration  1  0/15 (0.00%)  0 2/36 (5.56%)  2
Hypercalcemia  1  0/15 (0.00%)  0 1/36 (2.78%)  6
Hyperglycemia  1  5/15 (33.33%)  10 12/36 (33.33%)  46
Hyperkalemia  1  1/15 (6.67%)  2 2/36 (5.56%)  3
Hypernatremia  1  0/15 (0.00%)  0 1/36 (2.78%)  1
Hyperuricemia  1  0/15 (0.00%)  0 3/36 (8.33%)  9
Hypoalbuminemia  1  3/15 (20.00%)  7 3/36 (8.33%)  5
Hypocalcemia  1  2/15 (13.33%)  2 3/36 (8.33%)  3
Hypoglycemia  1  1/15 (6.67%)  4 1/36 (2.78%)  1
Hypokalemia  1  1/15 (6.67%)  2 2/36 (5.56%)  2
Hypomagnesemia  1  0/15 (0.00%)  0 1/36 (2.78%)  1
Hyponatremia  1  4/15 (26.67%)  4 6/36 (16.67%)  12
Hypophosphatemia  1  2/15 (13.33%)  3 5/36 (13.89%)  6
Musculoskeletal and connective tissue disorders     
Arthralgia  1  1/15 (6.67%)  1 6/36 (16.67%)  16
Arthritis  1  0/15 (0.00%)  0 3/36 (8.33%)  5
Back pain  1  5/15 (33.33%)  12 3/36 (8.33%)  3
Bone pain  1  0/15 (0.00%)  0 1/36 (2.78%)  1
Buttock pain  1  1/15 (6.67%)  1 0/36 (0.00%)  0
Chest wall pain  1  0/15 (0.00%)  0 1/36 (2.78%)  1
Generalized muscle weakness  1  0/15 (0.00%)  0 1/36 (2.78%)  1
Musculoskeletal and connective tissue disorder - Other, specify  1  0/15 (0.00%)  0 1/36 (2.78%)  1
Myalgia  1  2/15 (13.33%)  2 3/36 (8.33%)  4
Neck pain  1  0/15 (0.00%)  0 1/36 (2.78%)  1
Pain in extremity  1  3/15 (20.00%)  6 3/36 (8.33%)  6
Neoplasms benign, malignant and unspecified (incl cysts and polyps)     
Tumor pain  1  1/15 (6.67%)  5 1/36 (2.78%)  1
Nervous system disorders     
Brachial plexopathy  1  0/15 (0.00%)  0 1/36 (2.78%)  2
Dizziness  1  1/15 (6.67%)  1 5/36 (13.89%)  9
Dysarthria  1  0/15 (0.00%)  0 1/36 (2.78%)  1
Dysgeusia  1  1/15 (6.67%)  4 0/36 (0.00%)  0
Headache  1  2/15 (13.33%)  12 9/36 (25.00%)  19
Memory impairment  1  0/15 (0.00%)  0 1/36 (2.78%)  2
Peripheral sensory neuropathy  1  1/15 (6.67%)  2 3/36 (8.33%)  9
Presyncope  1  0/15 (0.00%)  0 1/36 (2.78%)  2
Sinus pain  1  0/15 (0.00%)  0 1/36 (2.78%)  1
Syncope  1  0/15 (0.00%)  0 1/36 (2.78%)  1
Psychiatric disorders     
Anxiety  1  1/15 (6.67%)  7 5/36 (13.89%)  16
Confusion  1  1/15 (6.67%)  2 1/36 (2.78%)  1
Depression  1  1/15 (6.67%)  1 2/36 (5.56%)  11
Insomnia  1  4/15 (26.67%)  6 11/36 (30.56%)  29
Restlessness  1  0/15 (0.00%)  0 2/36 (5.56%)  3
Renal and urinary disorders     
Chronic kidney disease  1  0/15 (0.00%)  0 2/36 (5.56%)  8
Urinary frequency  1  1/15 (6.67%)  1 1/36 (2.78%)  1
Urinary tract obstruction  1  0/15 (0.00%)  0 1/36 (2.78%)  1
Reproductive system and breast disorders     
Genital edema  1  1/15 (6.67%)  2 0/36 (0.00%)  0
Pelvic pain  1  0/15 (0.00%)  0 1/36 (2.78%)  1
Reproductive system and breast disorders - Other, specify  1  1/15 (6.67%)  2 0/36 (0.00%)  0
Respiratory, thoracic and mediastinal disorders     
Allergic rhinitis  1  2/15 (13.33%)  2 3/36 (8.33%)  6
Bronchospasm  1  0/15 (0.00%)  0 2/36 (5.56%)  2
Cough  1  4/15 (26.67%)  9 7/36 (19.44%)  12
Dyspnea  1  6/15 (40.00%)  13 12/36 (33.33%)  27
Epistaxis  1  1/15 (6.67%)  1 1/36 (2.78%)  1
Hoarseness  1  0/15 (0.00%)  0 1/36 (2.78%)  1
Laryngopharyngeal dysesthesia  1  0/15 (0.00%)  0 1/36 (2.78%)  1
Nasal congestion  1  1/15 (6.67%)  1 2/36 (5.56%)  2
Postnasal drip  1  1/15 (6.67%)  1 3/36 (8.33%)  3
Productive cough  1  1/15 (6.67%)  1 1/36 (2.78%)  2
Respiratory, thoracic and mediastinal disorders - Other, specify  1  3/15 (20.00%)  6 0/36 (0.00%)  0
Sore throat  1  3/15 (20.00%)  3 2/36 (5.56%)  2
Skin and subcutaneous tissue disorders     
Alopecia  1  0/15 (0.00%)  0 1/36 (2.78%)  1
Dry skin  1  0/15 (0.00%)  0 5/36 (13.89%)  11
Erythema multiforme  1  0/15 (0.00%)  0 2/36 (5.56%)  2
Hyperhidrosis  1  2/15 (13.33%)  5 2/36 (5.56%)  4
Pruritus  1  2/15 (13.33%)  3 7/36 (19.44%)  12
Rash acneiform  1  0/15 (0.00%)  0 3/36 (8.33%)  3
Rash maculo-papular  1  1/15 (6.67%)  1 2/36 (5.56%)  2
Skin and subcutaneous tissue disorders - Other, specify  1  1/15 (6.67%)  1 0/36 (0.00%)  0
Urticaria  1  1/15 (6.67%)  2 4/36 (11.11%)  6
Vascular disorders     
Flushing  1  0/15 (0.00%)  0 2/36 (5.56%)  5
Hot flashes  1  1/15 (6.67%)  2 2/36 (5.56%)  2
Hypertension  1  3/15 (20.00%)  13 11/36 (30.56%)  45
Hypotension  1  2/15 (13.33%)  2 2/36 (5.56%)  2
Lymphedema  1  0/15 (0.00%)  0 1/36 (2.78%)  2
Vascular disorders - Other, specify  1  0/15 (0.00%)  0 1/36 (2.78%)  7
1
Term from vocabulary, MedDRA 12
Indicates events were collected by systematic assessment
Certain Agreements
All Principal Investigators ARE employed by the organization sponsoring the study.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Cara Rosenbaum, MD
Organization: Weill Cornell Medicine Cornell University
Phone: (646) 962-6500
EMail: car9156@med.cornell.edu
Layout table for additonal information
Responsible Party: Alliance for Clinical Trials in Oncology
ClinicalTrials.gov Identifier: NCT01190449    
Other Study ID Numbers: CALGB-50901
CALGB-50901
GSK-CALGB-50901
CDR0000683083 ( Registry Identifier: NCI Physician Data Query )
First Submitted: August 26, 2010
First Posted: August 27, 2010
Results First Submitted: April 16, 2018
Results First Posted: July 26, 2018
Last Update Posted: July 10, 2019