Trial Outcomes & Findings for Ofatumumab in Treating Patients With Previously Untreated Stage II, Stage III, or Stage IV Follicular Non-Hodgkin Lymphoma (NCT NCT01190449)

NCT ID: NCT01190449

Last Updated: 2021-08-18

Results Overview

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.

Recruitment status

COMPLETED

Study phase

PHASE2

Target enrollment

51 participants

Primary outcome timeframe

From baseline to month 12

Results posted on

2021-08-18

Participant Flow

Participant milestones

Participant milestones
Measure	Arm I (Low-dose Ofatumumab) 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).	Arm II (High-dose Ofatumumab) 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 Study STARTED	15	36
Overall Study COMPLETED	15	32
Overall Study NOT COMPLETED	0	4

Reasons for withdrawal

Reasons for withdrawal
Measure	Arm I (Low-dose Ofatumumab) 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).	Arm II (High-dose Ofatumumab) 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 Study Ineligible	0	4

Baseline Characteristics

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

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Arm I (Low-dose Ofatumumab) n=15 Participants 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).	Arm II (High-dose Ofatumumab) n=36 Participants 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 n=51 Participants Total of all reporting groups
Age, Continuous	63 years n=5 Participants	58 years n=7 Participants	60 years n=5 Participants
Sex: Female, Male Female	4 Participants n=5 Participants	19 Participants n=7 Participants	23 Participants n=5 Participants
Sex: Female, Male Male	11 Participants n=5 Participants	17 Participants n=7 Participants	28 Participants n=5 Participants
Region of Enrollment United States	15 Participants n=5 Participants	36 Participants n=7 Participants	51 Participants n=5 Participants

PRIMARY outcome

Timeframe: From baseline to month 12

Population: Patients who completed the study and were not ineligible were included in this analysis.

Outcome measures

Outcome measures
Measure	Arm I (Low-dose Ofatumumab) n=15 Participants 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).	Arm II (High-dose Ofatumumab) n=32 Participants 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 Response Rate (Complete or Partial Response) by Month 12	60 percentage of patients Interval 32.0 to 84.0	84 percentage of patients Interval 67.0 to 95.0

SECONDARY outcome

Timeframe: 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

Population: Patients who completed the study and were not ineligible were included in this analysis.

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.

Outcome measures

Outcome measures
Measure	Arm I (Low-dose Ofatumumab) n=15 Participants 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).	Arm II (High-dose Ofatumumab) n=32 Participants 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).
Median Progression-free Survival Time	1.9 years Interval 1.0 to 1.9	1.9 years Interval 1.5 to 3.0

Adverse Events

Arm I (Low-dose Ofatumumab)

Serious events: 2 serious events

Other events: 15 other events

Deaths: 0 deaths

Arm II (High-dose Ofatumumab)

Serious events: 8 serious events

Other events: 35 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	Arm I (Low-dose Ofatumumab) n=15 participants at risk 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).	Arm II (High-dose Ofatumumab) n=36 participants at risk 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).
Cardiac disorders Acute coronary syndrome	0.00% 0/15 • From baseline to month 12 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.	2.8% 1/36 • Number of events 1 • From baseline to month 12 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.
Gastrointestinal disorders Small intestinal obstruction	0.00% 0/15 • From baseline to month 12 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.	2.8% 1/36 • Number of events 1 • From baseline to month 12 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.
General disorders Fatigue	0.00% 0/15 • From baseline to month 12 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.	2.8% 1/36 • Number of events 1 • From baseline to month 12 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.
General disorders Infusion related reaction	0.00% 0/15 • From baseline to month 12 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.	8.3% 3/36 • Number of events 3 • From baseline to month 12 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.
Infections and infestations Bone infection	6.7% 1/15 • Number of events 1 • From baseline to month 12 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.	0.00% 0/36 • From baseline to month 12 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.
Infections and infestations Infections and infestations - Other, specify	6.7% 1/15 • Number of events 1 • From baseline to month 12 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.	0.00% 0/36 • From baseline to month 12 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.
Investigations Lymphocyte count decreased	6.7% 1/15 • Number of events 1 • From baseline to month 12 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.	5.6% 2/36 • Number of events 2 • From baseline to month 12 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.
Investigations White blood cell decreased	0.00% 0/15 • From baseline to month 12 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.	2.8% 1/36 • Number of events 1 • From baseline to month 12 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.
Respiratory, thoracic and mediastinal disorders Pneumonitis	0.00% 0/15 • From baseline to month 12 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.	2.8% 1/36 • Number of events 1 • From baseline to month 12 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.

Other adverse events

Additional Information

Cara Rosenbaum, MD

Weill Cornell Medicine Cornell University

Phone: (646) 962-6500

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place