Neoplasms

Blood and Lymph Conditions

Immune System Diseases

All Conditions

Symptoms and General Pathology

Rare Diseases

Lymphoma, Large B-Cell, Diffuse

Lymphoma

Disease Progression

Lymphoma, B-Cell

Neoplasms by Histologic Type

Lymphoproliferative Disorders

Lymphatic Diseases

Immunoproliferative Disorders

Lymphoma, Non-Hodgkin

B-cell Lymphoma

Diffuse Large B-Cell Lymphoma

Lymphosarcoma

Antineoplastic Agents

All Drugs and Chemicals

Ofatumumab

8 weekly intra-venous (I.V.) infusions, 1 x 300mg and 7 x 1000mg

8 weekly intra-venous (i.v.) infusions, 1 x 300mg and 7 x 1000mg

GSK Clinical Trials

The purpose of this trial is to determine the effect of ofatumumab in patients with Diffused Large B-Cell Lymphoma (DLBCL) ineligible for transplant or relapsed after autologous transplant

Ofatumumab in Patients With Relapsed/Progressive Diffused Large B-Cell Lymphoma (DLBCL) Ineligible for or Relapse/Progression After Transplant

An Open-label, Single-arm. Multi-center Phase 2 Trial With Ofatumumab in Patients With Relapsed/Progressive Diffuse Large B-Cell Lymphoma (DLBCL) Ineligible for Transplant or Relapse/Progression After Autologous Transplant

Objective response of ofatumumab treatment was assessed according to the "revised response criteria for malignant lymphoma." Participants with objective response were defined as responders with complete remission (CR) or partial remission (PR) of disease. CR is defined as the disappearance of all evidence of disease, and PR is defined as the regression of measurable disease with no new sites of disease.

According to the "revised response criteria for malignant lymphoma," responders included participants with CR and PR, and non-responders included participants with stable disease (SD) and progressive disease (PD). Participants not evaluable (NE) were also considered to be non-responders. PD is defined as any new lesion or an increase by more than or equal to 50% of previously involved sites from baseline. SD is defined as failure to attain CR, PR, or PD.

The duration of response was defined as the time from the initial response (CR or PR) to the time of relapse, progression, or death. If the participant was lost to follow-up, the endpoint was censored, and the censoring date was the date of the last attended visit at which the endpoint was assessed.

PFS was defined as the time from treatment start until progression or death.

Time to next DLBCL therapy was defined as the time from the first infusion date to the time of the first administration of the next DLBCL treatment other than ofatumumab. If the participants were lost to follow-up, the endpoint was censored, and the censoring date was the date of the last attended visit at which the endpoint was assessed.

Overall survival is defined as the time from first infusion to death. Overall survival was a secondary endpoint in the study. However, since many participants withdrew from the study after developing disease progression overall survival could not be reliably estimated.

HAHA are indicators of immune response to ofatumumab. Blood samples were collected from participants at Visits 1, 12, 13, 14, and 18 and analyzed in batches. The number of participants with positive results at each visit is reported.

B cells (CD45+CD19+ and CD45+CD20+) were measured in peripheral blood samples by flow cytometry. Percent change from Baseline = (value at the indicated visits minus the value at Baseline divided by the value at Baseline) \* 100.

An AE is defined as any untoward medical occurrence in a participant administered a pharmaceutical product that does not necessarily have a causal relationship with this treatment. The protocol-defined AE reporting period was from the first infusion (Visit 2/Week 0) to Visit 18 (Month 24 of follow-up) or time of withdrawal (treatment and follow-up).

CH50 was mistakenly registered as an outcome measure with the protocol record. Samples were not collected, and no analysis will take place. Thus, no data will be reported for this outcome measure.

AUC is defined as the area under the ofatumumab concentration-time curve as a measure of drug exposure. AUC(0-168) is the AUC from the start of infusion to 168 hours after the start of the infusion; AUC(0-inf) is the AUC from the start of infusion extrapolated to infinity.

Cmax is defined as the maximum concentration of drug in serum samples. Ctrough is defined as the minimum observed concentration prior to the start of the next dose. No drug is present prior to the first infusion; therefore, there are no Ctrough results for the first dose.

t1/2 is defined as terminal half-life and is the time required for the amount of drug in the body to decrease by half.

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

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

GlaxoSmithKline

Participants received 8 weekly iv infusions of ofatumumab: first infusion of 300 mg, followed by 7 infusions of 1000 mg

Age, Continuous

Sex: Female, Male

Asian

Hispanic or Latino

White

Missing

Race/Ethnicity, Customized

Prior ASCT

Ineligible for ASCT

Study participants had to have either prior autologous stem cell transplant (ASCT) or had to be ineligible for ASCT to be eligible for inclusion.

Number of Participants with the Indicated Prior Therapy

GSK Response Center

Full Analysis Set (FAS): all participants who were exposed to study drug irrespective of their compliance to the planned course of treatment

Number of Participants With Objective Response

Responders with CR

Responders with PR

Non-responders with SD

Non-responders with PD

Non-responders with NE

Number of Participants Classified as Responders and Non-responders for Objective Response

FAS. Only participants with CR or PR were analyzed.

Duration of Response

Progression-free Survival (PFS)

Time to Next Diffuse Large B-Cell Lymphoma (DLBCL) Therapy

Overall Survival (OS)

Screening, n=79

Visit 12 (Month 6), n=20

Visit 13 (Month 9), n=16

Visit 14 (Month 12), n=16

Visit 18 (Month 24), n=8

End of Trial/Withdrawal, n=43

Overall Study Arm

FAS. Data are provided for the number of participants attending each visit.

Number of Participants With Positive Human Anti-human Antibodies (HAHA) at Screening and at Visits 12, 13, 14, and 18

CD45+CD19+, Visit 10 (Week 8), n=42

CD45+CD19+, Visit 11 (Week 11), n=29

CD45+CD19+, Visit 12 (Month 6), n=18

CD45+CD19+, Visit 13 (Month 9), n=15

CD45+CD19+, Visit 14 (Month 12), n=13

CD45+CD19+, Visit 15 (Month 15), n=12

CD45+CD19+, Visit 16 (Month 18), n=8

CD45+CD19+, Visit 17 (Month 21), n=8

CD45+CD19+, Visit 18 (Month 24), n=7

CD45+CD19+, Visit 19 (Month 30), n=2

CD45+CD19+, Visit 20 (Month 36), n=2

CD45+CD20+, Visit 10 (Week 8), n=42

CD45+CD20+, Visit 11 (Week 11), n=29

CD45+CD20+, Visit 12 (Month 6), n=18

CD45+CD20+, Visit 13 (Month 9), n=15

CD45+CD20+, Visit 14 (Month 12), n=13

CD45+CD20+, Visit 15 (Month 15), n=12

CD45+CD20+, Visit 16 (Month 18), n=8

CD45+CD20+, Visit 17 (Month 21), n=8

CD45+CD20+, Visit 18 (Month 24), n=5

CD45+CD20+, Visit 19 (Month 30), n=2

CD45+CD20+, Visit 20 (Month 36), n=2

Median Percent Change From Baseline in CD45+CD19+ and CD45+CD20+ Cells in the Peripheral Blood at the Indicated Visits

Number of Participants Who Experienced at Least One Adverse Event (AE)

Percent Change From Screening in Complement (CH50) Levels

AUC(0-inf), n=30

AUC(0-168), n=46

FAS. Data are provided for the number of participants attending each visit for whom the parameter value could be calculated. Participants contributing AUC(0-inf) data also contributed AUC(0-168) data.

AUC(0-inf) and AUC(0-168) for Ofatumumab at the Eighth Infusion

First infusion Cmax; 300 mg, n=74

Eighth infusion Cmax; 1000 mg, n=48

Eighth infusion Ctrough; 1000 mg, n=48

Cmax and Ctrough for Ofatumumab at the First and Eighth Infusions

FAS. Data are provided for the number of participants at each visit for whom the parameter could be calculated.

Half-life (T1/2) for Ofatumumab at the Eighth Infusion

FAS. Data are presented for the number of participants at each visit for whom the parameter can be calculated.

Clearance (CL) of Ofatumumab at the Eighth Infusion

FAS. Data are presented for the number of participants attending each visit for whom the parameter can be calculated.

Volume of Distribution at Steady State (Vss) of Ofatumumab at the Eighth Infusion

Participants received 8 weekly intravenous (iv) infusions of ofatumumab: first infusion of 300 milligrams (mg), followed by 7 infusions of 1000 mg

Spots Global Cancer Trial Database for Ofatumumab in Patients With Relapsed/Progressive Diffused Large B-Cell Lymphoma (DLBCL) Ineligible for or Relapse/Progression After Transplant

Trial Identification

Conditions

Interventions

Study Description

Keywords

Eligibility

Locations

Contact Details

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