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

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).

Time frame: Maximum of 23 months after the start of treatment

Population: FAS

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.

Time frame: 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 Participants withdrawn during the study were not analyzed.

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.

Time frame: 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 Participants withdrawn during the study were not analyzed.

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 \[taken directly before next administration\]).

Time frame: 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 Participants withdrawn during the study were not analyzed.

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.

Time frame: Followed up to 5 years

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

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

Time frame: 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 Participants withdrawn during the study were not analyzed.

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.

Time frame: 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 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.

Time frame: 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.

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.

Time frame: Up to 22 months after study start

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.

Time frame: Maximum of 6 years follow-up

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.

Time frame: Maximum of 23 months after the start of treatment

Population: FAS

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

Time frame: 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.

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.

Time frame: 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.

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

Time frame: 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.

Time frame: Followed up to 5 years

Population: FAS

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

Time frame: 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.