Trial Outcomes & Findings for Patients With Relapsed or Refractory Diffuse Large B Cell Non Hodgkin Lymphomas (NCT NCT01078922)

Last Updated: 2014-07-16

Results Overview

OR = # of patients with a Complete Response (CR) plus # of patients with a Partial Response (PR) divided by the total # of evaluable patients. A CR is defined as: 1. Disappearance of all disease. 2. If nodal masses that Positron Emission Tomography (PET)- positive prior to therapy; they must be PET negative 3. If the nodal masses were Variably or PET negative; they must regress to normal. 4. No palpable liver or spleen 5. Palpable nodal masses are no longer palpable 6. Negative bone marrow biopsy A PR is defined as: 1. Regression of measurable disease and no new sites of disease. 2. \> 50% decrease in Sum of Product of Diameters (SPD) of up to 6 largest masses with no increase in the size of other nodes. If the nodal masses were PET positive prior to therapy then PET positive at previously involved sites is allowed. If they were Variably or PET negative then regression on CT is required. 3. No increase in the size of the liver or spleen

Recruitment status

TERMINATED

Study phase

PHASE2

Target enrollment

11 participants

Primary outcome timeframe

evaluated every 2 months up to 80 weeks

Results posted on

2014-07-16

Participant Flow

Participant milestones

Participant milestones
Measure	Ofatumumab Ofatumumab: The first dose administered of ofatumumab should be 300 mg to minimize infusion reactions. The initial rate of the first infusion of 1000 mg ofatumumab (0.3mg/ml) should be 12ml/h. If no infusion reactions occur the infusion rate should be increased every 30 minutes, to a maximum of 400 ml/h. If this schedule is followed, the infusion duration will be approximately 4.5 hours.
Overall Study STARTED	11
Overall Study COMPLETED	10
Overall Study NOT COMPLETED	1

Reasons for withdrawal

Reasons for withdrawal
Measure	Ofatumumab Ofatumumab: The first dose administered of ofatumumab should be 300 mg to minimize infusion reactions. The initial rate of the first infusion of 1000 mg ofatumumab (0.3mg/ml) should be 12ml/h. If no infusion reactions occur the infusion rate should be increased every 30 minutes, to a maximum of 400 ml/h. If this schedule is followed, the infusion duration will be approximately 4.5 hours.
Overall Study Adverse Event	1

Baseline Characteristics

Patients With Relapsed or Refractory Diffuse Large B Cell Non Hodgkin Lymphomas

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Ofatumumab n=11 Participants The first dose administered of ofatumumab should be 300 mg to minimize infusion reactions. The initial rate of the first infusion of 1000 mg ofatumumab (0.3mg/ml) should be 12ml/h. If no infusion reactions occur the infusion rate should be increased every 30 minutes, to a maximum of 400 ml/h. If this schedule is followed, the infusion duration will be approximately 4.5 hours.
Age, Categorical <=18 years	0 Participants n=99 Participants
Age, Categorical Between 18 and 65 years	4 Participants n=99 Participants
Age, Categorical >=65 years	7 Participants n=99 Participants
Sex: Female, Male Female	7 Participants n=99 Participants
Sex: Female, Male Male	4 Participants n=99 Participants
Region of Enrollment United States	11 participants n=99 Participants

PRIMARY outcome

Timeframe: evaluated every 2 months up to 80 weeks

Population: Analysis was per protocol. Patients were evaluated every 2 cycles for Overall Response, up to 80 weeks.

Outcome measures

Outcome measures
Measure	Ofatumumab n=11 Participants Ofatumumab: The first dose administered of ofatumumab should be 300 mg to minimize infusion reactions. The initial rate of the first infusion of 1000 mg ofatumumab (0.3mg/ml) should be 12ml/h. If no infusion reactions occur the infusion rate should be increased every 30 minutes, to a maximum of 400 ml/h. If this schedule is followed, the infusion duration will be approximately 4.5 hours.
Overall Response (OR)	18 percentage of participants

SECONDARY outcome

Timeframe: Evaluated every 2 cycles (every 2 months), up to 80 weeks

OCB = # patients with a CR + # of patients with a PR + # patients with Stable Disease (SD) divided by the number of evaluable patients CR and PR is defined in Outcome Measure #1 SD is defined as: 1. Failure to attain CR/PR or Progressive Disease (PD) 2. PET remains positive. PD is defined as: 1. Any new lesion \> 1.5 cm in longest axis 2. An increase 50% or more of previously involved sites from nadir 3. 50% increase in SPD of more than one node or 50% increase in the longest diameter of a previously identified node that is \> 1 cm in shortest axis 4. PET remains positive if it was positive before therapy.

Outcome measures

Outcome measures
Measure	Ofatumumab n=11 Participants Ofatumumab: The first dose administered of ofatumumab should be 300 mg to minimize infusion reactions. The initial rate of the first infusion of 1000 mg ofatumumab (0.3mg/ml) should be 12ml/h. If no infusion reactions occur the infusion rate should be increased every 30 minutes, to a maximum of 400 ml/h. If this schedule is followed, the infusion duration will be approximately 4.5 hours.
Overall Clinical Benefit (OCB)	36 percentage of participants

Adverse Events

Ofatumumab

Serious events: 5 serious events

Other events: 11 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	Ofatumumab n=11 participants at risk The first dose administered of ofatumumab should be 300 mg to minimize infusion reactions. The initial rate of the first infusion of 1000 mg ofatumumab (0.3mg/ml) should be 12ml/h. If no infusion reactions occur the infusion rate should be increased every 30 minutes, to a maximum of 400 ml/h. If this schedule is followed, the infusion duration will be approximately 4.5 hours. Ofatumumab: The first dose administered of ofatumumab should be 300 mg to minimize infusion reactions. The initial rate of the first infusion of 1000 mg ofatumumab (0.3mg/ml) should be 12ml/h. If no infusion reactions occur the infusion rate should be increased every 30 minutes, to a maximum of 400 ml/h. If this schedule is followed, the infusion duration will be approximately 4.5 hours.
General disorders Pain	9.1% 1/11
General disorders Graft versus host disease	9.1% 1/11 • Number of events 2
General disorders Vertigo	9.1% 1/11
Gastrointestinal disorders Subcapsular liver hemorrhage	9.1% 1/11
Gastrointestinal disorders Diarrhea	9.1% 1/11
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Basal Cell Carcinoma	9.1% 1/11
Gastrointestinal disorders Reflux esophagitis	9.1% 1/11
General disorders Death-disease progression	9.1% 1/11

Other adverse events

Other adverse events
Measure	Ofatumumab n=11 participants at risk The first dose administered of ofatumumab should be 300 mg to minimize infusion reactions. The initial rate of the first infusion of 1000 mg ofatumumab (0.3mg/ml) should be 12ml/h. If no infusion reactions occur the infusion rate should be increased every 30 minutes, to a maximum of 400 ml/h. If this schedule is followed, the infusion duration will be approximately 4.5 hours. Ofatumumab: The first dose administered of ofatumumab should be 300 mg to minimize infusion reactions. The initial rate of the first infusion of 1000 mg ofatumumab (0.3mg/ml) should be 12ml/h. If no infusion reactions occur the infusion rate should be increased every 30 minutes, to a maximum of 400 ml/h. If this schedule is followed, the infusion duration will be approximately 4.5 hours.
Blood and lymphatic system disorders Alkaline Phosphatase	18.2% 2/11
Blood and lymphatic system disorders anemia	45.5% 5/11
Metabolism and nutrition disorders Anorexia	54.5% 6/11
Psychiatric disorders Anxiety	9.1% 1/11
General disorders Alopecia	36.4% 4/11
General disorders Abdominal discomfort	27.3% 3/11
Musculoskeletal and connective tissue disorders Arthralgia	9.1% 1/11
Renal and urinary disorders increased bilirubin	9.1% 1/11
Infections and infestations bacteremia	9.1% 1/11
Renal and urinary disorders increased creatinine	9.1% 1/11
Gastrointestinal disorders Constipation	27.3% 3/11
Respiratory, thoracic and mediastinal disorders cough	18.2% 2/11
General disorders Chills	18.2% 2/11
Infections and infestations cold	18.2% 2/11
Eye disorders conjunctival irritation	9.1% 1/11
Musculoskeletal and connective tissue disorders cramps	9.1% 1/11
Psychiatric disorders depression	9.1% 1/11
Gastrointestinal disorders diarrhea	45.5% 5/11
General disorders dry mucous membranes	18.2% 2/11
Respiratory, thoracic and mediastinal disorders dyspnea on exertion	9.1% 1/11
Respiratory, thoracic and mediastinal disorders dyspnea	9.1% 1/11
Skin and subcutaneous tissue disorders dry skin	9.1% 1/11
Vascular disorders edema	36.4% 4/11
Gastrointestinal disorders epigastric pain	9.1% 1/11
Eye disorders eye pain	9.1% 1/11
Eye disorders eye edema	9.1% 1/11
General disorders fatigue	54.5% 6/11
Infections and infestations fever	18.2% 2/11
General disorders flushing to face	9.1% 1/11
Gastrointestinal disorders gastritis	9.1% 1/11
Gastrointestinal disorders hemorroids	9.1% 1/11
Nervous system disorders headache	9.1% 1/11
Cardiac disorders increased heart rate	9.1% 1/11
Blood and lymphatic system disorders hypocalcemia	27.3% 3/11
Blood and lymphatic system disorders hypokalemia	27.3% 3/11
Blood and lymphatic system disorders hyponatremia	36.4% 4/11
Gastrointestinal disorders hypoalbuminemia	27.3% 3/11
Blood and lymphatic system disorders hypomagnesemia	9.1% 1/11
Endocrine disorders hyperglycemia	18.2% 2/11
Blood and lymphatic system disorders hyperkalemia	9.1% 1/11
Cardiac disorders hypertension	18.2% 2/11
Blood and lymphatic system disorders hypercalcemia	9.1% 1/11
General disorders insomnia	18.2% 2/11
Skin and subcutaneous tissue disorders itchiness	18.2% 2/11
Infections and infestations infection	9.1% 1/11
Blood and lymphatic system disorders leukopenia	27.3% 3/11
Blood and lymphatic system disorders lyphmopenia	36.4% 4/11
Musculoskeletal and connective tissue disorders neck stiffness	9.1% 1/11
Psychiatric disorders nervousness	9.1% 1/11
Blood and lymphatic system disorders neutropenia	36.4% 4/11
General disorders nasal congestion	9.1% 1/11
Nervous system disorders neuropathy	36.4% 4/11
Gastrointestinal disorders nausea	45.5% 5/11
General disorders night sweats	9.1% 1/11
Respiratory, thoracic and mediastinal disorders pleural effusion	9.1% 1/11
General disorders pain	54.5% 6/11
General disorders parasthasia lower extremities	9.1% 1/11
Skin and subcutaneous tissue disorders rash	18.2% 2/11
General disorders sinus pressure	9.1% 1/11
Respiratory, thoracic and mediastinal disorders shortness of breath	9.1% 1/11
Skin and subcutaneous tissue disorders skin tears	9.1% 1/11
Blood and lymphatic system disorders thrombocytopenia	18.2% 2/11
Gastrointestinal disorders taste alteration	9.1% 1/11
Gastrointestinal disorders throat scratchy	9.1% 1/11
Infections and infestations urinary tract infection	9.1% 1/11
Gastrointestinal disorders ulcer	9.1% 1/11
Gastrointestinal disorders vomiting	45.5% 5/11
Gastrointestinal disorders viral infection	9.1% 1/11
General disorders vocal cord paralysis	9.1% 1/11
Eye disorders watery eyes	9.1% 1/11
General disorders weakness	18.2% 2/11

Additional Information

Research Manager

Oncology Specialists, SC

Phone: 847-410-0658

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place