Trial Outcomes & Findings for Ofatumumab for Initial Systemic Treatment of Indolent B-cell Lymphoma (NCT NCT01239394)

Last Updated: 2017-10-18

Results Overview

Evaluate clinical efficacy of ofatumumab in previously untreated indolent B-cell lymphomas, as measured by complete response rate (CRR). Complete response = all previously enlarged fluorodeoxyglucose (FDG)-avid or positron emission tomography (PET)-positive lymph nodes regressed to normal size (\<=1.5 cm in greatest diameter)

Recruitment status

COMPLETED

Study phase

PHASE2

Target enrollment

43 participants

Primary outcome timeframe

1-month post-treatment

Results posted on

2017-10-18

Participant Flow

The number enrolled (43) and number starting study (42) do not match because one patient never began study treatment due to an acute stroke prior to any study treatment.

Participant milestones

Participant milestones
Measure	Ofatumumab single-arm, open-label, interventional ofatumumab: Weekly infusion for 8 weeks
Overall Study STARTED	42
Overall Study COMPLETED	41
Overall Study NOT COMPLETED	1

Reasons for withdrawal

Reasons for withdrawal
Measure	Ofatumumab single-arm, open-label, interventional ofatumumab: Weekly infusion for 8 weeks
Overall Study Adverse Event	1

Baseline Characteristics

Ofatumumab for Initial Systemic Treatment of Indolent B-cell Lymphoma

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Ofatumumab n=42 Participants single-arm, open-label, interventional ofatumumab: Weekly infusion for 8 weeks
Age, Continuous	64.4 years n=5 Participants
Sex: Female, Male Female	18 Participants n=5 Participants
Sex: Female, Male Male	24 Participants n=5 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	2 Participants n=5 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	35 Participants n=5 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	5 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants
Race (NIH/OMB) Asian	0 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	1 Participants n=5 Participants
Race (NIH/OMB) White	36 Participants n=5 Participants
Race (NIH/OMB) More than one race	2 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	3 Participants n=5 Participants
Region of Enrollment United States	42 participants n=5 Participants
Lymphoma type Follicular	28 Participants n=5 Participants
Lymphoma type Marginal zone	4 Participants n=5 Participants
Lymphoma type Small lymphocytic	10 Participants n=5 Participants

PRIMARY outcome

Timeframe: 1-month post-treatment

Outcome measures

Outcome measures
Measure	Ofatumumab n=41 Participants single-arm, open-label, interventional ofatumumab: Weekly infusion for 8 weeks
Efficacy: Complete Response Rate (CRR)	9.5 percentage of patients

SECONDARY outcome

Timeframe: 1-month post-treatment

Evaluate clinical efficacy of ofatumumab in previously untreated indolent B-cell lymphomas, as measured by overall response rate (ORR). Overall response = Complete response (CR) + Partial response (PR) CR = all previously enlarged fluorodeoxyglucose (FDG)-avid or positron emission tomography (PET)-positive lymph nodes regressed to normal size (\<=1.5cm in greatest diameter) PR = \>=50% decrease in SPD of up to six largest dominant masses, no increase in size of other nodes; FDG avid or PET positive before therapy, one or more nodes PET positive at previously involved site, or variably FDG avid or PET negative with regression at CT

Outcome measures

Outcome measures
Measure	Ofatumumab n=41 Participants single-arm, open-label, interventional ofatumumab: Weekly infusion for 8 weeks
Overall Response Rate (ORR)	52 percentage of patients

SECONDARY outcome

Timeframe: 12 months

Percentage of patients with progression-free survival during 12 months post-treatment progression-free survival: patients live with the disease, but it does not get worse

Outcome measures

Outcome measures
Measure	Ofatumumab n=41 Participants single-arm, open-label, interventional ofatumumab: Weekly infusion for 8 weeks
Progression-free Survival (PFS)	86 percentage of patients Interval 72.0 to 99.0

SECONDARY outcome

Timeframe: 2 years

Evaluate safety of ofatumumab monotherapy in this patient population Toxicities are graded 1 (mild), 2 (moderate), 3 (severe), and 4 (life-threatening)

Outcome measures

Outcome measures
Measure	Ofatumumab n=42 Participants single-arm, open-label, interventional ofatumumab: Weekly infusion for 8 weeks
Toxicity: Infusion Reactions, Grade 3-4 Infections, and Neutropenia Infusion reactions (grade 1-2)	22 Participants
Toxicity: Infusion Reactions, Grade 3-4 Infections, and Neutropenia Infusion reactions (grade 3)	7 Participants
Toxicity: Infusion Reactions, Grade 3-4 Infections, and Neutropenia Infections (grade 3-4)	1 Participants
Toxicity: Infusion Reactions, Grade 3-4 Infections, and Neutropenia Neutropenia (grade 3-4)	0 Participants

Adverse Events

Ofatumumab

Serious events: 2 serious events

Other events: 38 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	Ofatumumab n=42 participants at risk single-arm, open-label, interventional ofatumumab: Weekly infusion for 8 weeks
Nervous system disorders Vestibular Schwannoma	2.4% 1/42 • Number of events 1
Respiratory, thoracic and mediastinal disorders Pneumonia	2.4% 1/42 • Number of events 1
General disorders Fever	2.4% 1/42 • Number of events 1
Nervous system disorders Headache	2.4% 1/42 • Number of events 1
Eye disorders Photophobia	2.4% 1/42 • Number of events 1

Other adverse events

Other adverse events
Measure	Ofatumumab n=42 participants at risk single-arm, open-label, interventional ofatumumab: Weekly infusion for 8 weeks
Immune system disorders Allergic reaction	66.7% 28/42 • Number of events 30
General disorders Fatigue	45.2% 19/42 • Number of events 21
Gastrointestinal disorders Nausea	21.4% 9/42 • Number of events 12
Nervous system disorders Headache	16.7% 7/42 • Number of events 7
Gastrointestinal disorders Diarrhea	14.3% 6/42 • Number of events 8
Respiratory, thoracic and mediastinal disorders Cough	14.3% 6/42 • Number of events 6
General disorders Infusion related react	14.3% 6/42 • Number of events 6
Gastrointestinal disorders Abdominal pain	11.9% 5/42 • Number of events 7
Skin and subcutaneous tissue disorders Pruritus	11.9% 5/42 • Number of events 6
Respiratory, thoracic and mediastinal disorders Dyspnea	11.9% 5/42 • Number of events 5
Psychiatric disorders Insomnia	11.9% 5/42 • Number of events 5
Investigations Platelet count decrease	11.9% 5/42 • Number of events 5
Blood and lymphatic system disorders Anemia	9.5% 4/42 • Number of events 6
Musculoskeletal and connective tissue disorders Back pain	9.5% 4/42 • Number of events 5
Skin and subcutaneous tissue disorders Rash maculo-papular	9.5% 4/42 • Number of events 5
Musculoskeletal and connective tissue disorders Arthralgia	9.5% 4/42 • Number of events 4
Investigations Blood bilirubin increase	9.5% 4/42 • Number of events 4
Gastrointestinal disorders Constipation	9.5% 4/42 • Number of events 4
Musculoskeletal and connective tissue disorders Pain in extremity	9.5% 4/42 • Number of events 4
Skin and subcutaneous tissue disorders Skin and subcutaneous	9.5% 4/42 • Number of events 4
Investigations Alanine aminotransferase	7.1% 3/42 • Number of events 5
Psychiatric disorders Anxiety	7.1% 3/42 • Number of events 3
Infections and infestations Bladder infection	7.1% 3/42 • Number of events 3
Nervous system disorders Dizziness	7.1% 3/42 • Number of events 3
Gastrointestinal disorders Dyspepsia	7.1% 3/42 • Number of events 3
Investigations Neutrophil count decrease	7.1% 3/42 • Number of events 3
Gastrointestinal disorders Vomiting	7.1% 3/42 • Number of events 3

Additional Information

Jeremy Abramson, MD

Massachusetts General Hospital Cancer Center

Phone: 617-724-4000

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place