Trial Outcomes & Findings for Ofatumumab (Humax-CD20) With CHOP (Cyclophosphamide,Doxorubicin, Vincristine, Predisolone) in Follicular Lymphoma (FL) Patients (NCT NCT00494780)

Last Updated: 2014-07-11

Results Overview

Based on standardized response criteria for NHL, responders included participants with CR (complete disappearance of all detectable clinical and radiographic evidence of disease), CRu (more than a 75% decrease in LN size compared to baseline), and PR (\>=50% decrease in LN size and evidence of new lesions). Non-responders included participants with stable disease (SD; \<50% decrease in LN size from baseline) and progressive disease (PD; \>=50% increase in LN size and evidence of new lesions).

Recruitment status

COMPLETED

Study phase

PHASE2

Target enrollment

59 participants

Primary outcome timeframe

Maximum of 23 months after the start of treatment

Results posted on

2014-07-11

Participant Flow

Participant milestones

Participant milestones
Measure	500 mg Ofatumumab + CHOP Ofatumumab was given on Day 1 and CHOP (cyclophosphamide, doxorubicin, vincristine, prednisolone) on Day 3 of each 21-day cycle, with 300 milligrams (mg) in Cycle 1 and 500 mg in Cycles 2 to 6. Participants were followed up for 15 weeks during the Treatment period; then every 3 months for 24 months in the Follow-up period; then every 6 months until Month 60 or withdrawal from the study.	1000 mg Ofatumumab + CHOP Ofatumumab was given on Day 1 and CHOP on Day 3 of each 21-day cycle, with 300 mg in Cycle 1 and 1000 mg in Cycles 2 to 6. Participants were followed up for 15 weeks during the Treatment period; then every 3 months for 24 months in the Follow-up period; then every 6 months until Month 60 or withdrawal from the study.
Overall Study STARTED	29	30
Overall Study COMPLETED	18	17
Overall Study NOT COMPLETED	11	13

Reasons for withdrawal

Reasons for withdrawal
Measure	500 mg Ofatumumab + CHOP Ofatumumab was given on Day 1 and CHOP (cyclophosphamide, doxorubicin, vincristine, prednisolone) on Day 3 of each 21-day cycle, with 300 milligrams (mg) in Cycle 1 and 500 mg in Cycles 2 to 6. Participants were followed up for 15 weeks during the Treatment period; then every 3 months for 24 months in the Follow-up period; then every 6 months until Month 60 or withdrawal from the study.	1000 mg Ofatumumab + CHOP Ofatumumab was given on Day 1 and CHOP on Day 3 of each 21-day cycle, with 300 mg in Cycle 1 and 1000 mg in Cycles 2 to 6. Participants were followed up for 15 weeks during the Treatment period; then every 3 months for 24 months in the Follow-up period; then every 6 months until Month 60 or withdrawal from the study.
Overall Study Adverse Event	1	0
Overall Study Withdrew before Dosed	0	1
Overall Study Progression of Study Disease	7	8
Overall Study New Treatment	2	2
Overall Study Non-compliance	1	0
Overall Study Residual Tumour Mass	0	1
Overall Study Insurance Issues	0	1

Baseline Characteristics

Ofatumumab (Humax-CD20) With CHOP (Cyclophosphamide,Doxorubicin, Vincristine, Predisolone) in Follicular Lymphoma (FL) Patients

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	500 mg Ofatumumab + CHOP n=29 Participants Ofatumumab was given on Day 1 and CHOP on Day 3 of each 21-day cycle, with 300 mg in Cycle 1 and 500 mg in Cycles 2 to 6. Participants were followed up for 15 weeks during the Treatment period; then every 3 months for 24 months in the Follow-up period; then every 6 months until Month 60 or withdrawal from the study.	1000 mg Ofatumumab + CHOP n=29 Participants Ofatumumab was given on Day 1 and CHOP on Day 3 of each 21-day cycle, with 300 mg in Cycle 1 and 1000 mg in Cycles 2 to 6. Participants were followed up for 15 weeks during the Treatment period; then every 3 months for 24 months in the Follow-up period; then every 6 months until Month 60 or withdrawal from the study.	Total n=58 Participants Total of all reporting groups
Race/Ethnicity, Customized White	29 participants n=5 Participants	27 participants n=7 Participants	56 participants n=5 Participants
Age, Continuous	54.1 Years STANDARD_DEVIATION 11.4 • n=5 Participants	53.7 Years STANDARD_DEVIATION 9.14 • n=7 Participants	53.9 Years STANDARD_DEVIATION 10.2 • n=5 Participants
Sex: Female, Male Female	14 Participants n=5 Participants	21 Participants n=7 Participants	35 Participants n=5 Participants
Sex: Female, Male Male	15 Participants n=5 Participants	8 Participants n=7 Participants	23 Participants n=5 Participants
Race/Ethnicity, Customized Hispanic or Latino	0 participants n=5 Participants	2 participants n=7 Participants	2 participants n=5 Participants

PRIMARY outcome

Timeframe: Maximum of 23 months after the start of treatment

Population: FAS

Outcome measures

Outcome measures
Measure	500 mg Ofatumumab + CHOP n=29 Participants Ofatumumab was given on Day 1 and CHOP on Day 3 of each 21-day cycle, with 300 mg in Cycle 1 and 500 mg in Cycles 2 to 6. Participants were followed up for 15 weeks during the Treatment period; then every 3 months for 24 months in the Follow-up period; then every 6 months until Month 60 or withdrawal from the study.	1000 mg Ofatumumab + CHOP n=29 Participants Ofatumumab was given on Day 1 and CHOP on Day 3 of each 21-day cycle, with 300 mg in Cycle 1 and 1000 mg in Cycles 2 to 6. Participants were followed up for 15 weeks during the Treatment period; then every 3 months for 24 months in the Follow-up period; then every 6 months until Month 60 or withdrawal from the study.
Number of Participants With the Indicated Overall Best Response (OBR) at Visit 26 (3 Months After the Last Infusion of Ofatumumab) Responder, PR	10 participants	13 participants
Number of Participants With the Indicated Overall Best Response (OBR) at Visit 26 (3 Months After the Last Infusion of Ofatumumab) Non-Responder, SD	2 participants	0 participants
Number of Participants With the Indicated Overall Best Response (OBR) at Visit 26 (3 Months After the Last Infusion of Ofatumumab) Non-Responder, PD	1 participants	0 participants
Number of Participants With the Indicated Overall Best Response (OBR) at Visit 26 (3 Months After the Last Infusion of Ofatumumab) Responder, CR	6 participants	9 participants
Number of Participants With the Indicated Overall Best Response (OBR) at Visit 26 (3 Months After the Last Infusion of Ofatumumab) Responder, CRu	10 participants	7 participants

SECONDARY outcome

Timeframe: Maximum of 23 months after the start of treatment

Population: FAS

Participants were evaluated for response by an Independent Endpoint Review Committee in accordance with the standardized response criteria for NHL. Participants with CR were defined as those with the complete disappearance of all detectable clinical and radiographic evidence of disease.

Outcome measures

Outcome measures
Measure	500 mg Ofatumumab + CHOP n=29 Participants Ofatumumab was given on Day 1 and CHOP on Day 3 of each 21-day cycle, with 300 mg in Cycle 1 and 500 mg in Cycles 2 to 6. Participants were followed up for 15 weeks during the Treatment period; then every 3 months for 24 months in the Follow-up period; then every 6 months until Month 60 or withdrawal from the study.	1000 mg Ofatumumab + CHOP n=29 Participants Ofatumumab was given on Day 1 and CHOP on Day 3 of each 21-day cycle, with 300 mg in Cycle 1 and 1000 mg in Cycles 2 to 6. Participants were followed up for 15 weeks during the Treatment period; then every 3 months for 24 months in the Follow-up period; then every 6 months until Month 60 or withdrawal from the study.
Number of Participants With Complete Remission (CR) at Visit 26	6 participants	9 participants

SECONDARY outcome

Timeframe: Maximum of 24 months after the last infusion of Ofatumumab (Visit 33; median of 33.8 months)

Population: FAS. Participants were withdrawn from the study between Visits 1 and 33.

The tumor size for a participant was computed as the sum of product of diameters (SPD) for the indicator lesions. Reduction in tumor size was calculated as percent change from Visit 1 until Visit 33, separately by radiologist 1 and radiologist 2. Percent change from Visit 1 (Screening, Week -2) = (value at Visit 33 minus value at Visit 1 divided by value at Visit 1) \* 100.

Outcome measures

Outcome measures
Measure	500 mg Ofatumumab + CHOP n=17 Participants Ofatumumab was given on Day 1 and CHOP on Day 3 of each 21-day cycle, with 300 mg in Cycle 1 and 500 mg in Cycles 2 to 6. Participants were followed up for 15 weeks during the Treatment period; then every 3 months for 24 months in the Follow-up period; then every 6 months until Month 60 or withdrawal from the study.	1000 mg Ofatumumab + CHOP n=16 Participants Ofatumumab was given on Day 1 and CHOP on Day 3 of each 21-day cycle, with 300 mg in Cycle 1 and 1000 mg in Cycles 2 to 6. Participants were followed up for 15 weeks during the Treatment period; then every 3 months for 24 months in the Follow-up period; then every 6 months until Month 60 or withdrawal from the study.
Median Percent Change From Visit 1 (Screening, Week -2) in Tumor Size at Visit 33 (24 Months After the Last Infusion of Ofatumumab) Radiologist 1	-100 Percent change in tumor size Interval -100.0 to 17.0	-100 Percent change in tumor size Interval -100.0 to -80.0
Median Percent Change From Visit 1 (Screening, Week -2) in Tumor Size at Visit 33 (24 Months After the Last Infusion of Ofatumumab) Radiologist 2	-100 Percent change in tumor size Interval -100.0 to -25.0	-100 Percent change in tumor size Interval -100.0 to -79.0

SECONDARY outcome

Timeframe: Followed up to 5 years

Population: FAS

Time to new FL therapy is defined as the time from randomization until the time of first administration of the new FL therapy other than ofatumumab. Time to new FL therapy will be censored if participants are lost to follow-up. The censoring date in such cases will be the date of the last attended visit at which the endpoint was assessed.

Outcome measures

Outcome measures
Measure	500 mg Ofatumumab + CHOP n=29 Participants Ofatumumab was given on Day 1 and CHOP on Day 3 of each 21-day cycle, with 300 mg in Cycle 1 and 500 mg in Cycles 2 to 6. Participants were followed up for 15 weeks during the Treatment period; then every 3 months for 24 months in the Follow-up period; then every 6 months until Month 60 or withdrawal from the study.	1000 mg Ofatumumab + CHOP n=29 Participants Ofatumumab was given on Day 1 and CHOP on Day 3 of each 21-day cycle, with 300 mg in Cycle 1 and 1000 mg in Cycles 2 to 6. Participants were followed up for 15 weeks during the Treatment period; then every 3 months for 24 months in the Follow-up period; then every 6 months until Month 60 or withdrawal from the study.
Time to New Anti-follicular Lymphoma (FL) Therapy	47.2 months Interval 30.4 to There were too few participants; therefore, the upper limit of the CI could not be estimated.	NA months Interval 32.2 to There were too few participants; therefore, the median and the upper limit of the CI could not be estimated.

SECONDARY outcome

Timeframe: Followed up to 5 years

Population: FAS

PFS is defined as the time from randomization until progression or death.

Outcome measures

Outcome measures
Measure	500 mg Ofatumumab + CHOP n=29 Participants Ofatumumab was given on Day 1 and CHOP on Day 3 of each 21-day cycle, with 300 mg in Cycle 1 and 500 mg in Cycles 2 to 6. Participants were followed up for 15 weeks during the Treatment period; then every 3 months for 24 months in the Follow-up period; then every 6 months until Month 60 or withdrawal from the study.	1000 mg Ofatumumab + CHOP n=29 Participants Ofatumumab was given on Day 1 and CHOP on Day 3 of each 21-day cycle, with 300 mg in Cycle 1 and 1000 mg in Cycles 2 to 6. Participants were followed up for 15 weeks during the Treatment period; then every 3 months for 24 months in the Follow-up period; then every 6 months until Month 60 or withdrawal from the study.
Progression-Free Survival (PFS)	27.6 months Interval 15.1 to 28.3	NA months Interval 21.3 to There were too few events for the median and upper limit of the CI to be estimated.

SECONDARY outcome

Timeframe: Followed up to 5 years

Population: FAS. Only those participants with a response were analyzed.

The duration of response is defined as the time from the initial response (the first visit at which response was observed) to progression or death.

Outcome measures

Outcome measures
Measure	500 mg Ofatumumab + CHOP n=26 Participants Ofatumumab was given on Day 1 and CHOP on Day 3 of each 21-day cycle, with 300 mg in Cycle 1 and 500 mg in Cycles 2 to 6. Participants were followed up for 15 weeks during the Treatment period; then every 3 months for 24 months in the Follow-up period; then every 6 months until Month 60 or withdrawal from the study.	1000 mg Ofatumumab + CHOP n=29 Participants Ofatumumab was given on Day 1 and CHOP on Day 3 of each 21-day cycle, with 300 mg in Cycle 1 and 1000 mg in Cycles 2 to 6. Participants were followed up for 15 weeks during the Treatment period; then every 3 months for 24 months in the Follow-up period; then every 6 months until Month 60 or withdrawal from the study.
Duration of Response	21.0 months Interval 13.3 to 26.2	25.0 months Interval 13.7 to There were too few events for the upper limit of the CI to be estimated.

SECONDARY outcome

Timeframe: Maximum of 24 months after the last infusion of Ofatumumab (Visit 33; median of 33.8 months)

Population: FAS. Only those participants who provided samples at Visit 33 were analyzed.

The peripheral blood for each participant was collected and analyzed for CD19+ and CD20+ cell counts. CD19+ and CD20+ are B-cell types which are used as an index of a participant's response to treatment.

Outcome measures

Outcome measures
Measure	500 mg Ofatumumab + CHOP n=17 Participants Ofatumumab was given on Day 1 and CHOP on Day 3 of each 21-day cycle, with 300 mg in Cycle 1 and 500 mg in Cycles 2 to 6. Participants were followed up for 15 weeks during the Treatment period; then every 3 months for 24 months in the Follow-up period; then every 6 months until Month 60 or withdrawal from the study.	1000 mg Ofatumumab + CHOP n=16 Participants Ofatumumab was given on Day 1 and CHOP on Day 3 of each 21-day cycle, with 300 mg in Cycle 1 and 1000 mg in Cycles 2 to 6. Participants were followed up for 15 weeks during the Treatment period; then every 3 months for 24 months in the Follow-up period; then every 6 months until Month 60 or withdrawal from the study.
Percent Change From Visit 1 (Screening) in Peripheral CD19+ and CD20+ Cell Counts at Visit 33 (24 Months After the Last Infusion of Ofatumumab) CD19+	154.1 Percent change in cell counts Interval -95.0 to 748.0	307.9 Percent change in cell counts Interval -51.0 to 1767.0
Percent Change From Visit 1 (Screening) in Peripheral CD19+ and CD20+ Cell Counts at Visit 33 (24 Months After the Last Infusion of Ofatumumab) CD20+	154.1 Percent change in cell counts Interval -95.0 to 520.0	307.9 Percent change in cell counts Interval -51.0 to 1767.0

SECONDARY outcome

Timeframe: Up to 22 months after study start

Population: FAS

An adverse event is defined as any untoward medical occurrence in a participant administered a pharmaceutical product and which did not necessarily have a causal relationship with the treatment. A list of AEs experienced in the study with a frequency threshold of 5% can be found in the AE section.

Outcome measures

Outcome measures
Measure	500 mg Ofatumumab + CHOP n=29 Participants Ofatumumab was given on Day 1 and CHOP on Day 3 of each 21-day cycle, with 300 mg in Cycle 1 and 500 mg in Cycles 2 to 6. Participants were followed up for 15 weeks during the Treatment period; then every 3 months for 24 months in the Follow-up period; then every 6 months until Month 60 or withdrawal from the study.	1000 mg Ofatumumab + CHOP n=29 Participants Ofatumumab was given on Day 1 and CHOP on Day 3 of each 21-day cycle, with 300 mg in Cycle 1 and 1000 mg in Cycles 2 to 6. Participants were followed up for 15 weeks during the Treatment period; then every 3 months for 24 months in the Follow-up period; then every 6 months until Month 60 or withdrawal from the study.
Number of Participants Who Experienced Any Adverse Event (AEs) From First Treatment to Visit 33 (24 Months After Last Infusion)	29 participants	29 participants

SECONDARY outcome

Timeframe: Visits 1 (Screening), 28 (9 months after last dose), and 33 (24 months after last dose)

Population: FAS. Participants dropped out of the study as the study progressed.

HAHA are indicators of immunogenicity to ofatumumab. Blood samples were drawn from participants at Visits 1, 28, and 33 for analysis of HAHA.

Outcome measures

Outcome measures
Measure	500 mg Ofatumumab + CHOP n=29 Participants Ofatumumab was given on Day 1 and CHOP on Day 3 of each 21-day cycle, with 300 mg in Cycle 1 and 500 mg in Cycles 2 to 6. Participants were followed up for 15 weeks during the Treatment period; then every 3 months for 24 months in the Follow-up period; then every 6 months until Month 60 or withdrawal from the study.	1000 mg Ofatumumab + CHOP n=29 Participants Ofatumumab was given on Day 1 and CHOP on Day 3 of each 21-day cycle, with 300 mg in Cycle 1 and 1000 mg in Cycles 2 to 6. Participants were followed up for 15 weeks during the Treatment period; then every 3 months for 24 months in the Follow-up period; then every 6 months until Month 60 or withdrawal from the study.
Number of Participants With Positive Human Anti-human Antibodies (HAHA) at Visits 1, 28, and 33 Visit 1, n=29, 29	0 participants	0 participants
Number of Participants With Positive Human Anti-human Antibodies (HAHA) at Visits 1, 28, and 33 Visit 28, n=18, 21	0 participants	0 participants
Number of Participants With Positive Human Anti-human Antibodies (HAHA) at Visits 1, 28, and 33 Visit 33, n=16, 16	0 participants	0 participants

SECONDARY outcome

Timeframe: Visit 1 (Screening, Week -2) and Visit 22 (Week 15)

Population: FAS. Only those participants who remained in the study at Visit 22 were analyzed.

The peripheral blood for each participant was collected and analyzed for serum complement CH50 levels. Cluster of Differentiation index 50 (CD50) is a human gene which is used as an index of immune response. CD50Percent change from Visit 1 (Screening, Week -2) = (value at Visit 22 minus value at Visit 1 divided by value at Visit 1) \* 100.

Outcome measures

Outcome measures
Measure	500 mg Ofatumumab + CHOP n=24 Participants Ofatumumab was given on Day 1 and CHOP on Day 3 of each 21-day cycle, with 300 mg in Cycle 1 and 500 mg in Cycles 2 to 6. Participants were followed up for 15 weeks during the Treatment period; then every 3 months for 24 months in the Follow-up period; then every 6 months until Month 60 or withdrawal from the study.	1000 mg Ofatumumab + CHOP n=28 Participants Ofatumumab was given on Day 1 and CHOP on Day 3 of each 21-day cycle, with 300 mg in Cycle 1 and 1000 mg in Cycles 2 to 6. Participants were followed up for 15 weeks during the Treatment period; then every 3 months for 24 months in the Follow-up period; then every 6 months until Month 60 or withdrawal from the study.
Median Percent Change From Visit 1 (Screening) in Serum Complement (CH50) Levels at Visit 22	42.0 Percent change in serum complement CH50 Interval -36.0 to 450.0	23.2 Percent change in serum complement CH50 Interval -55.0 to 620.0

SECONDARY outcome

Timeframe: Maximum of 6 years follow-up

Population: FAS

This is a genetic prognostic marker of FL response. The former sponsor decided to not analyze these samples; therefore, no results are presented.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Week 15 (Visit 22)

Population: FAS. Data were provided for the number of participants who had a value. Participants withdrawn during the study were not analyzed.

Cmax is defined as the maximum concentration of drug in plasma samples. Ctrough is defined as the trough plasma concentration (measured concentration at the end of a dosing interval \[taken directly before next administration\]).

Outcome measures

Outcome measures
Measure	500 mg Ofatumumab + CHOP n=26 Participants Ofatumumab was given on Day 1 and CHOP on Day 3 of each 21-day cycle, with 300 mg in Cycle 1 and 500 mg in Cycles 2 to 6. Participants were followed up for 15 weeks during the Treatment period; then every 3 months for 24 months in the Follow-up period; then every 6 months until Month 60 or withdrawal from the study.	1000 mg Ofatumumab + CHOP n=29 Participants Ofatumumab was given on Day 1 and CHOP on Day 3 of each 21-day cycle, with 300 mg in Cycle 1 and 1000 mg in Cycles 2 to 6. Participants were followed up for 15 weeks during the Treatment period; then every 3 months for 24 months in the Follow-up period; then every 6 months until Month 60 or withdrawal from the study.
Cmax and Ctrough at the Sixth Infusion (Week 15, Visit 22) Cmax	232 milligrams per liter (mg/L) Geometric Coefficient of Variation 0.25	497 milligrams per liter (mg/L) Geometric Coefficient of Variation 0.26
Cmax and Ctrough at the Sixth Infusion (Week 15, Visit 22) Ctrough	78.5 milligrams per liter (mg/L) Geometric Coefficient of Variation 0.50	188 milligrams per liter (mg/L) Geometric Coefficient of Variation 0.47

SECONDARY outcome

Timeframe: Week 15 (Visit 22)

Population: FAS. Data were provided for the number of participants for whom the parameter could be calculated. Participants withdrawn during the study were not analyzed.

AUC is defined as the area under the ofatumumab concentration-time curve as a measure of drug exposure. AUC(0-504) is AUC from the start of infusion to 504 hours after the start of the infusion; AUC(0-inf) is AUC from the start of infusion extrapolated to infinity.

Outcome measures

Outcome measures
Measure	500 mg Ofatumumab + CHOP n=25 Participants Ofatumumab was given on Day 1 and CHOP on Day 3 of each 21-day cycle, with 300 mg in Cycle 1 and 500 mg in Cycles 2 to 6. Participants were followed up for 15 weeks during the Treatment period; then every 3 months for 24 months in the Follow-up period; then every 6 months until Month 60 or withdrawal from the study.	1000 mg Ofatumumab + CHOP n=29 Participants Ofatumumab was given on Day 1 and CHOP on Day 3 of each 21-day cycle, with 300 mg in Cycle 1 and 1000 mg in Cycles 2 to 6. Participants were followed up for 15 weeks during the Treatment period; then every 3 months for 24 months in the Follow-up period; then every 6 months until Month 60 or withdrawal from the study.
AUC(0-inf) and AUC(0-504) After the Sixth Infusion (Week 15, Visit 22) AUC(0-inf), n=20, 28	177133 Milligrams * hours/liter (mg.h/L) Geometric Coefficient of Variation 0.41	399676 Milligrams * hours/liter (mg.h/L) Geometric Coefficient of Variation 0.47
AUC(0-inf) and AUC(0-504) After the Sixth Infusion (Week 15, Visit 22) AUC(0-504), n=24, 28	79500 Milligrams * hours/liter (mg.h/L) Geometric Coefficient of Variation 0.26	168866 Milligrams * hours/liter (mg.h/L) Geometric Coefficient of Variation 0.33

SECONDARY outcome

Timeframe: Week 15 (Visit 22)

Population: FAS. Data were provided for the number of participants attending each visit for whom the parameter could be calculated. Participants withdrawn during the study were not analyzed.

Half life is defined as the period of time required for the amount of drug in the body to be reduced by half.

Outcome measures

Outcome measures
Measure	500 mg Ofatumumab + CHOP n=23 Participants Ofatumumab was given on Day 1 and CHOP on Day 3 of each 21-day cycle, with 300 mg in Cycle 1 and 500 mg in Cycles 2 to 6. Participants were followed up for 15 weeks during the Treatment period; then every 3 months for 24 months in the Follow-up period; then every 6 months until Month 60 or withdrawal from the study.	1000 mg Ofatumumab + CHOP n=29 Participants Ofatumumab was given on Day 1 and CHOP on Day 3 of each 21-day cycle, with 300 mg in Cycle 1 and 1000 mg in Cycles 2 to 6. Participants were followed up for 15 weeks during the Treatment period; then every 3 months for 24 months in the Follow-up period; then every 6 months until Month 60 or withdrawal from the study.
Half Life (t1/2) of Ofatumumab at the Sixth Infusion (Week 15, Visit 22)	652 hours Geometric Coefficient of Variation 0.57	644 hours Geometric Coefficient of Variation 0.32

SECONDARY outcome

Timeframe: Week 15 (Visit 22)

Population: FAS. Data were provided for the number of participants attending each visit for whom the parameter could be calculated. Participants withdrawn during the study were not analyzed.

CL is the clearance of drug from plasma, which is defined as the volume of plasma from which the drug is cleared per unit time.

Outcome measures

Outcome measures
Measure	500 mg Ofatumumab + CHOP n=26 Participants Ofatumumab was given on Day 1 and CHOP on Day 3 of each 21-day cycle, with 300 mg in Cycle 1 and 500 mg in Cycles 2 to 6. Participants were followed up for 15 weeks during the Treatment period; then every 3 months for 24 months in the Follow-up period; then every 6 months until Month 60 or withdrawal from the study.	1000 mg Ofatumumab + CHOP n=29 Participants Ofatumumab was given on Day 1 and CHOP on Day 3 of each 21-day cycle, with 300 mg in Cycle 1 and 1000 mg in Cycles 2 to 6. Participants were followed up for 15 weeks during the Treatment period; then every 3 months for 24 months in the Follow-up period; then every 6 months until Month 60 or withdrawal from the study.
CL After the Sixth Infusion (Week 15, Visit 22)	6.29 Milliliters per hour (mL/h) Geometric Coefficient of Variation 0.26	5.92 Milliliters per hour (mL/h) Geometric Coefficient of Variation 0.33

SECONDARY outcome

Timeframe: Week 15 (Visit 22)

Population: FAS. Data were provided for the number of participants attending each visit for whom the parameter could be calculated. Participants withdrawn during the study were not analyzed.

Vss is defined as the volume of distribution at steady state of ofatumumab.

Outcome measures

Outcome measures
Measure	500 mg Ofatumumab + CHOP n=23 Participants Ofatumumab was given on Day 1 and CHOP on Day 3 of each 21-day cycle, with 300 mg in Cycle 1 and 500 mg in Cycles 2 to 6. Participants were followed up for 15 weeks during the Treatment period; then every 3 months for 24 months in the Follow-up period; then every 6 months until Month 60 or withdrawal from the study.	1000 mg Ofatumumab + CHOP n=29 Participants Ofatumumab was given on Day 1 and CHOP on Day 3 of each 21-day cycle, with 300 mg in Cycle 1 and 1000 mg in Cycles 2 to 6. Participants were followed up for 15 weeks during the Treatment period; then every 3 months for 24 months in the Follow-up period; then every 6 months until Month 60 or withdrawal from the study.
Vss at the Sixth Infusion (Week 15, Visit 22)	5.15 Liters Geometric Coefficient of Variation 0.34	5.32 Liters Geometric Coefficient of Variation 0.38

Adverse Events

500 mg Ofatumumab + CHOP

Serious events: 13 serious events

Other events: 29 other events

Deaths: 0 deaths

1000 mg Ofatumumab + CHOP

Serious events: 11 serious events

Other events: 28 other events

Deaths: 0 deaths

500 mg Ofatumumab + CHOP: Extended Follow-up

Serious events: 1 serious events

Other events: 0 other events

Deaths: 0 deaths

1000 mg Ofatumumab + CHOP: Extended Follow-up

Serious events: 6 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Other adverse events

Additional Information

GSK Response Center

GlaxoSmithKline

Phone: 866-435-7343

Results disclosure agreements

Principal investigator is a sponsor employee GSK agreements may vary with individual investigators, but will not prohibit any investigator from publishing. GSK supports the publication of results from all centers of a multi-center trial but requests that reports based on single-site data not precede the primary publication of the entire clinical trial.
Publication restrictions are in place

Restriction type: OTHER