Trial Outcomes & Findings for Ofatumumab and Bortezomib in Subjects With Relapsed CD20+Diffuse Large B Cell, Follicular, or Mantle Cell Lymphoma (NCT NCT01397591)

Last Updated: 2014-07-30

Results Overview

Based on International Working Group (IWG) criteria, recorded in four categories: Complete Response (CR), disappearance of all evidence of disease; Partial Response (PR), regression of measurable disease and no new sites of disease; Progressive Disease (PD), Any new lesion or increase by \>= 50% of previously involved sites from nadir. Stable Disease (SD), failure to attain CR/PR or PD. A response is defined to be either CR/PR. A failure in response includes SD/PD.

Recruitment status

TERMINATED

Study phase

PHASE2

Target enrollment

3 participants

Primary outcome timeframe

Every 2 cycles during treatment and then every 3 months for 2 years

Results posted on

2014-07-30

Participant Flow

3 subjects enrolled on study but 1 of the 3 was a screen failure so only 2 subjects were assigned to study treatment.

Participant milestones

Participant milestones
Measure	Ofatumumab in Combination With Bortezomib All patients were given Ofatumumab in combination with Bortezomib in treatment cycles lasting 28 days. Ofatumumab was given intravenously on cycle 1 day 1 at a dose of 300mg, followed by a cycle 1 day 8 dose of 1000mg. During cycles 2 through cycle 6, Ofatumumab was given at a dose of 1000mg on day 1 of each cycle, with no dosing on any other day of the cycle. Bortezomib was given intravenously at a dose of 1.6mg/m2 on days 1, 8, and 15 of each cycle, following the Ofatumumab infusion, if given.
Overall Study STARTED	2
Overall Study COMPLETED	2
Overall Study NOT COMPLETED	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Ofatumumab and Bortezomib in Subjects With Relapsed CD20+Diffuse Large B Cell, Follicular, or Mantle Cell Lymphoma

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Ofatumumab in Combination With Bortezomib n=2 Participants All patients were given Ofatumumab in combination with Bortezomib in treatment cycles lasting 28 days. Ofatumumab was given intravenously on cycle 1 day 1 at a dose of 300mg, followed by a cycle 1 day 8 dose of 1000mg. During cycles 2 through cycle 6, Ofatumumab was given at a dose of 1000mg on day 1 of each cycle, with no dosing on any other day of the cycle. Bortezomib was given intravenously at a dose of 1.6mg/m2 on days 1, 8, and 15 of each cycle, following the Ofatumumab infusion, if given.
Age, Continuous	63.5 years STANDARD_DEVIATION 10.6 • n=5 Participants
Age, Categorical <=18 years	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	1 Participants n=5 Participants
Age, Categorical >=65 years	1 Participants n=5 Participants
Sex: Female, Male Female	1 Participants n=5 Participants
Sex: Female, Male Male	1 Participants n=5 Participants
Region of Enrollment United States	2 participants n=5 Participants

PRIMARY outcome

Timeframe: Every 2 cycles during treatment and then every 3 months for 2 years

Outcome measures

Outcome measures
Measure	Treatment (Monoclonal Antibody and Enzyme Inhibitor Therapy) n=2 Participants Patients receive ofatumumab IV over 2.5 hours on days 1 and 8 of course 1, and day 1 of all subsequent courses. Patients also receive bortezomib IV over 3-5 seconds on days 1, 8, and 15. Treatment repeats every 28 days for up to 6 courses in the absence of disease progression or unacceptable toxicity. ofatumumab: Given IV bortezomib: Given IV laboratory biomarker analysis: Correlative studies enzyme-linked immunosorbent assay: Correlative studies biopsy: Optional correlative studies quality-of-life assessment: Ancillary studies polymorphism analysis: Correlative studies flow cytometry: Correlative studies
Response Rate of Ofatumumab in Combination With Bortezomib in Patients With Relapsed CD20+ (Cluster of DIfferentiation Antigen 20) Diffuse Large B Cell Lymphoma, Follicular Lymphoma, or Mantle Cell Lymphoma	2 participants

SECONDARY outcome

Timeframe: Up to every 3 months for 2 years

Population: Study closed by PI due to lack of accrual before this outcome measure could be analyzed.

This outcome measure is defined as the time from initiation of treatment to death due to any cause.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Up to every 3 months for 2 years

Population: Study closed by PI due to lack of accrual before this outcome measure could be analyzed.

This outcome measure is defined as the length of time after treatment during which the patient survives with no sign of the disease.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Up to every 3 months for 2 years

Population: Study closed by PI due to lack of accrual before this outcome measure could be analyzed.

The period of time between complete remission and recurrence of disease.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Days 1, 8, and 15 of each course and 4-6 weeks after final treatment

Toxicities and adverse experiences will be assessed at each visit using the NCI Common Toxicity Criteria for Adverse Events v4.0 Interim analyses on toxicity will be implemented based on the toxicity endpoints of the first 6 patients, and will be conducted sequentially 4 weeks after the treatment of each patient, or when serious toxicity has been observed for the patient, whichever comes earlier. we assume a non-informative prior distribution (Beta (0.001, 0.001)) for toxicity rate, and compute the posterior distribution of toxicity rate sequentially.

Outcome measures

Outcome measures
Measure	Treatment (Monoclonal Antibody and Enzyme Inhibitor Therapy) n=2 Participants Patients receive ofatumumab IV over 2.5 hours on days 1 and 8 of course 1, and day 1 of all subsequent courses. Patients also receive bortezomib IV over 3-5 seconds on days 1, 8, and 15. Treatment repeats every 28 days for up to 6 courses in the absence of disease progression or unacceptable toxicity. ofatumumab: Given IV bortezomib: Given IV laboratory biomarker analysis: Correlative studies enzyme-linked immunosorbent assay: Correlative studies biopsy: Optional correlative studies quality-of-life assessment: Ancillary studies polymorphism analysis: Correlative studies flow cytometry: Correlative studies
Number of Participants With Adverse Events (Toxicity)	2 participants

Adverse Events

Ofatumumab in Combination With Bortezomib

Serious events: 0 serious events

Other events: 2 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Other adverse events
Measure	Ofatumumab in Combination With Bortezomib n=2 participants at risk All patients were given Ofatumumab in combination with Bortezomib in treatment cycles lasting 28 days. Ofatumumab was given intravenously on cycle 1 day 1 at a dose of 300mg, followed by a cycle 1 day 8 dose of 1000mg. During cycles 2 through cycle 6, Ofatumumab was given at a dose of 1000mg on day 1 of each cycle, with no dosing on any other day of the cycle. Bortezomib was given intravenously at a dose of 1.6mg/m2 on days 1, 8, and 15 of each cycle, following the Ofatumumab infusion, if given.
Gastrointestinal disorders Nausea	50.0% 1/2 • Number of events 1
Psychiatric disorders Insomnia	50.0% 1/2 • Number of events 1
Gastrointestinal disorders Dysgeusia	50.0% 1/2 • Number of events 1
Immune system disorders Infusion Reaction	50.0% 1/2 • Number of events 1
Nervous system disorders Dizziness	50.0% 1/2 • Number of events 1
Psychiatric disorders Anxiety	50.0% 1/2 • Number of events 1
Gastrointestinal disorders Constipation	50.0% 1/2 • Number of events 1
General disorders Anorexia	50.0% 1/2 • Number of events 1
Gastrointestinal disorders Vomiting	50.0% 1/2 • Number of events 1
Nervous system disorders Sensory Neuropathy	50.0% 1/2 • Number of events 1
Musculoskeletal and connective tissue disorders Arthralgia	50.0% 1/2 • Number of events 1
General disorders Fatigue	100.0% 2/2 • Number of events 2
Gastrointestinal disorders Diarrhea	50.0% 1/2 • Number of events 1
Musculoskeletal and connective tissue disorders Back Pain	50.0% 1/2 • Number of events 1
Respiratory, thoracic and mediastinal disorders Dyspnea	50.0% 1/2 • Number of events 1
Blood and lymphatic system disorders Thrombocytopenia	50.0% 1/2 • Number of events 1
Gastrointestinal disorders Upper GI Hemorrhage	50.0% 1/2 • Number of events 1
Psychiatric disorders Confusion	50.0% 1/2 • Number of events 1
Gastrointestinal disorders Laryngeal Inflammation	50.0% 1/2 • Number of events 1
Nervous system disorders Headache	50.0% 1/2 • Number of events 1
Psychiatric disorders Memory Impairment	50.0% 1/2 • Number of events 1

Additional Information

Jeff Donovan

OHSU Knight Investigational Cancer Services

Phone: 503-494-7702

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place