- Duration of Response [ Time Frame: From start of treatment (Week 0) until Month 24 ] [ Designated as safety issue: No ]
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. For participants who were lost to follow-up, duration of response was censored at the date of the last attended visit at which the endpoint was assessed. The Kaplan-Meier method was used to estimate duration of response.
- Progression-Free Survival [ Time Frame: From start of treatment (Week 0) until Month 24 ] [ Designated as safety issue: No ]
Progression-free survival (PFS) is defined as the time from randomization until the first radiologically or clinically documented evidence of progression or death due to any cause, if sooner. For participants who were lost to follow-up, PFS was censored at the date of the last attended visit at which the endpoint was assessed. The Kaplan-Meier method was used to estimate PFS.
- Time to Next Follicular Lymphoma (FL) Therapy [ Time Frame: From start of treatment (Week 0) until Month 24 ] [ Designated as safety issue: No ]
Time to next FL (anti-lymphoma) therapy is defined as the time from randomization until the time of first administration of the next anti-lymphoma therapy other than ofatumumab. For participants who were lost to follow-up, the time was censored at the date of the last attended visit at which the endpoint was assessed.
- Overall Survival [ Time Frame: First dose (Week 0) until Week 24 ] [ Designated as safety issue: No ]
Overall survival is defined as the time from randomization until death. For participants who are lost to follow-up, overall survival will be censored at the date of the last attended visit at which the endpoint was assessed.
- Percent Change From Screening (Visit 1) in Tumor Size as Assessed by Radiologist 1 (R1) and Radiologist 2 (R2) at Months 3, 6, 9, 12, 18, and 24 [ Time Frame: Visits 1 (Week -2), 11 (Month 3), 12 (Month 6), 13 (Month 9), 14 (Month 12), 16 (Month 18), and 18 (Month 24) ] [ Designated as safety issue: No ]
Tumor size was measured by computed tomography (CT) scan and was computed as the sum of product of diameters (SPD) for the indicator lesions. CT scans with contrast of the neck, thorax, abdomen, and pelvis were performed at Screening and during the follow-up period (Month 3, 6, 9, 12, 18, and 24). The change in tumor size from Screening (Visit 1) was presented per Radiologist 1 (R1) and Radiologist 2 (R2). Percent change from Screening (Visit 1, Week -2) = (value at Visits 11, 12, 13, 14, 16, and 18 minus the value at Visit 1 divided by the value at Visit 1) * 100.
- Percent Change From Baseline (Visit 2) in CD19+ and CD20+ Cells in Peripheral Blood at Visits 11 and 12 [ Time Frame: Visits 2 (Baseline), 11 (Month 3), and 12 (Month 6) ] [ Designated as safety issue: No ]
CD19 and CD20 are proteins found on the cell surface of B cells, and they can be detected in peripheral blood by flow cytometry. Flow cytometry of peripheral blood was performed for immediate analysis of cells with cluster of differentiation 19 (CD19+) and CD20+. The analysis will be done until a value is reached that is in the normal range. Percent change from Baseline (Visit 2) = (value at Visits 11 and 12 minus the value at Visit 2 divided by the value at Visit 2) * 100.
- Number of Participants With Conversion and no Conversion of BCL2 Positive to BCL2 Negative in Peripheral Blood [ Time Frame: Screening (Visit 1) until Month 24 (Visit 18) ] [ Designated as safety issue: No ]
B-cell lymphoma 2 (BCL2) is the second member of a range of proteins initially described in chromosomal translocations involving chromosomes 14 and 18 in follicular lymphomas. BCL2 mitochondrial ribonucleic acid (mRNA) was measured by polymerase chain reaction (PCR) from peripheral blood. Participants who had no post-screening data were categorized as "Missing."
- Number of Participants Who Experienced Any Adverse Event From First Treatment (Visit 2) to Visit 18 (Month 24) [ Time Frame: From first treatment (Visit 2) until Visit 18 (Month 24) ] [ Designated as safety issue: Yes ]
An adverse event (AE) is defined as any untoward medical occurrence in a participant administered a pharmaceutical product and which did not necessarily have a causal relationship with this treatment. A list of AEs experienced in the study at a frequency threshold of 5% can be found in the AE section.
- Number of Participants With Positive Human Anti-human Antibodies (HAHA) at Visits 1, 12, 13, and 14 [ Time Frame: Visits 1 (Screening), 12 (Month 6), 13 (Month 9), and 18 (Month 24) ] [ Designated as safety issue: No ]
HAHA are indicators of immunogenicity to ofatumumab. Blood samples were withdrawn from participants at Visits 1, 12, 13, and 18 for analysis of HAHA. Analysis of HAHA was done in batches.
- Complement (CH50) Levels at Visit 1 and at the End of Infusion at Visit 2 [ Time Frame: Visits 1 (Week -2) and 2 (Week 0) ] [ Designated as safety issue: No ]
Blood samples were drawn from participants at Visits 1 and 2 for analysis of complement (CH50) levels. Analysis of CH50 was done in batches, and CH50 levels were measured two hours after the end of study medication infusion. Percent change from Screening (Visit 1, Week -2) = (value at Visit 2 minus the value at Visit 1 divided by the value at Visit 1) * 100.
- Number of Participants Classified as Responders for Fragment C Receptor (FcR) Polymorphism (Poly.) [ Time Frame: From first treatment (Visit 2) until Visit 12 (Month 6) ] [ Designated as safety issue: No ]
FcR poly. affect the affinity with which FcRs interact with immunoglobulin molecules and are prognostic factors that are indicative of altered responsiveness to treatment and/or survival. A blood sample was drawn at Visit 1 for analysis (done in batches of several samples) of FcR poly. (Fcgamma RIIIa Valine/Phenylalanine genotypes [TT=thymidine/thymidine, TG=thymidine/guanine, GG=guanine/guanine] and Fcgamma RIIa Arginine/Histidine genotypes [AA=adenine/adenine, AG=adenine/guanine, GG=guanine/guanine]). Responders must have met the criteria for CR, CRu, or PR at either Month 3 or Month 6.
- Ctrough and Cmax at the Eighth Infusion (Visit 9, Week 7) [ Time Frame: Visit 9 (Week 7; up to 10 months after dose) ] [ Designated as safety issue: No ]
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 the start of the next infusion]).
- AUC(0-inf) and AUC(0-168) After the Eighth Infusion (Visit 9, Week 7) [ Time Frame: Visit 9 (Week 7; up to 10 months after dose) ] [ Designated as safety issue: No ]
AUC is defined as the area under the ofatumumab concentration-time curve as a measure of drug exposure. AUC(0-168) is AUC from the start of infusion to 168 hours after the start of the infusion; AUC(0-inf) is AUC from the start of infusion extrapolated to infinity.
- t1/2 After the Eighth Infusion (Visit 9, Week 7) [ Time Frame: Visit 9 (Week 7; up to 10 months after dose) ] [ Designated as safety issue: No ]
t1/2 is defined as terminal half-life, which is the time required for the amount of the drug in the body to decrease by half.
- CL After the Eighth Infusion (Visit 9, Week 7) [ Time Frame: Visit 9 (Week 7; up to 10 months after dose) ] [ Designated as safety issue: No ]
CL is the clearance of drug from plasma, which is defined as the volume of plasma from which drug is removed per unit time.
- Vss After the Eighth Infusion (Visit 9, Week 7) [ Time Frame: Visit 9 (Week 7; to up 10 months after dose) ] [ Designated as safety issue: No ]
Vss is the volume of distribution at steady state of ofatumumab.
Purpose
