Trial Outcomes & Findings for Ofatumumab for High-Risk Chronic Lymphocytic Leukemia (CLL)/Small Lymphocytic Lymphoma (SLL) (NCT NCT01243190)

Last Updated: 2024-09-19

Results Overview

2008 International Workshop on CLL (IWCLL) update of the National Cancer Institute-sponsored Working Group (NCI-WG) outlined specific criteria of Complete Response (CR) for diagnosing CLL. CR is defined as Marrow normocellular, no CLL cells, no B-lymphoid nodules, hemoglobin of ≥11.0 g/dL (untransfused and without erythropoietin), Platelet count of ≥100 × 10\^9/L, circulating lymphocyte count normal, no constitutional symptoms, Liver and/or spleen size \<13 cm; liver size normal, lymph nodes ≥ 1.5 cm.

Recruitment status

COMPLETED

Study phase

PHASE2

Target enrollment

44 participants

Primary outcome timeframe

Up to 12 years

Results posted on

2024-09-19

Participant Flow

Participant milestones

Participant milestones
Measure	Ofatumumab Loading dose 300 mg by vein on Day 1 of Cycle 1; and full dose 1000 mg over 4 hours 1 time each week for 7 additional weekly doses (8 doses). Ofatumumab: Loading first dose 300 mg by vein on Day 1 of Cycle 1; and full dose 1000 mg over 4 hours 1 time each week for 7 additional weekly doses (8 doses).
Overall Study STARTED	44
Overall Study COMPLETED	44
Overall Study NOT COMPLETED	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Ofatumumab for High-Risk Chronic Lymphocytic Leukemia (CLL)/Small Lymphocytic Lymphoma (SLL)

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Ofatumumab n=44 Participants Loading dose 300 mg by vein on Day 1 of Cycle 1; and full dose 1000 mg over 4 hours 1 time each week for 7 additional weekly doses (8 doses). Ofatumumab: Loading first dose 300 mg by vein on Day 1 of Cycle 1; and full dose 1000 mg over 4 hours 1 time each week for 7 additional weekly doses (8 doses).
Age, Categorical <=18 years	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	32 Participants n=5 Participants
Age, Categorical >=65 years	12 Participants n=5 Participants
Age, Continuous	59 years n=5 Participants
Sex: Female, Male Female	17 Participants n=5 Participants
Sex: Female, Male Male	27 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants
Race (NIH/OMB) Asian	1 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	1 Participants n=5 Participants
Race (NIH/OMB) Black or African American	2 Participants n=5 Participants
Race (NIH/OMB) White	38 Participants n=5 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	2 Participants n=5 Participants
Region of Enrollment United States	44 participants n=5 Participants

PRIMARY outcome

Timeframe: Up to 12 years

Population: Of the 44 participants registered, 43 were evaluable for response.

Outcome measures

Outcome measures
Measure	Ofatumumab n=43 Participants Loading dose 300 mg by vein on Day 1 of Cycle 1; and full dose 1000 mg over 4 hours 1 time each week for 7 additional weekly doses (8 doses). Ofatumumab: Loading first dose 300 mg by vein on Day 1 of Cycle 1; and full dose 1000 mg over 4 hours 1 time each week for 7 additional weekly doses (8 doses).
Number of Patients With Complete Response (CR)	11 Participants

Adverse Events

Ofatumumab

Serious events: 22 serious events

Other events: 44 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	Ofatumumab n=44 participants at risk Loading dose 300 mg by vein on Day 1 of Cycle 1; and full dose 1000 mg over 4 hours 1 time each week for 7 additional weekly doses (8 doses). Ofatumumab: Loading first dose 300 mg by vein on Day 1 of Cycle 1; and full dose 1000 mg over 4 hours 1 time each week for 7 additional weekly doses (8 doses).
Investigations INFUSION REACTION	47.7% 21/44 • Number of events 21 • Up to 12 years
Immune system disorders AUTOIMMUNE HEPATITIS	2.3% 1/44 • Number of events 1 • Up to 12 years
Investigations ELEVATED AST	2.3% 1/44 • Number of events 1 • Up to 12 years
Surgical and medical procedures LIVER BX	2.3% 1/44 • Number of events 1 • Up to 12 years
General disorders RADIATING LEG PAIN	2.3% 1/44 • Number of events 1 • Up to 12 years
Infections and infestations SHINGLES	2.3% 1/44 • Number of events 1 • Up to 12 years

Other adverse events

Other adverse events
Measure	Ofatumumab n=44 participants at risk Loading dose 300 mg by vein on Day 1 of Cycle 1; and full dose 1000 mg over 4 hours 1 time each week for 7 additional weekly doses (8 doses). Ofatumumab: Loading first dose 300 mg by vein on Day 1 of Cycle 1; and full dose 1000 mg over 4 hours 1 time each week for 7 additional weekly doses (8 doses).
Vascular disorders Hypertension	6.8% 3/44 • Number of events 3 • Up to 12 years
Cardiac disorders Bradycardia	25.0% 11/44 • Number of events 11 • Up to 12 years
Respiratory, thoracic and mediastinal disorders cough	25.0% 11/44 • Number of events 11 • Up to 12 years
Gastrointestinal disorders Diarrhea	9.1% 4/44 • Number of events 4 • Up to 12 years
General disorders fatigue	72.7% 32/44 • Number of events 32 • Up to 12 years
Nervous system disorders headache	11.4% 5/44 • Number of events 5 • Up to 12 years
Respiratory, thoracic and mediastinal disorders Nasal Congestion	11.4% 5/44 • Number of events 5 • Up to 12 years
Gastrointestinal disorders Nausea	15.9% 7/44 • Number of events 7 • Up to 12 years
General disorders Back Pain	6.8% 3/44 • Number of events 3 • Up to 12 years
General disorders Neck Pain	9.1% 4/44 • Number of events 4 • Up to 12 years
Gastrointestinal disorders Stoma pain	6.8% 3/44 • Number of events 3 • Up to 12 years
Skin and subcutaneous tissue disorders Rash	15.9% 7/44 • Number of events 7 • Up to 12 years
Respiratory, thoracic and mediastinal disorders Sore Throat	6.8% 3/44 • Number of events 3 • Up to 12 years
Cardiac disorders Tachycardia	9.1% 4/44 • Number of events 4 • Up to 12 years
Blood and lymphatic system disorders Anemia	61.4% 27/44 • Number of events 27 • Up to 12 years
Blood and lymphatic system disorders Neutropenia	38.6% 17/44 • Number of events 17 • Up to 12 years
Blood and lymphatic system disorders Thrombocytopenia	56.8% 25/44 • Number of events 25 • Up to 12 years
Investigations Lymphocytes	34.1% 15/44 • Number of events 15 • Up to 12 years

Additional Information

William Wierda MD./Professor

The university of Texas MD Anderson Cancer Center

Phone: 713-745-0428

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place