Overview

This trial is active, not recruiting.

Condition lymphoma, large-cell, diffuse
Treatment ofatumumab
Phase phase 2
Sponsor GlaxoSmithKline
Start date December 2007
End date May 2010
Trial size 81 participants
Trial identifier NCT00622388, 111776, GEN415

Summary

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

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation non-randomized
Endpoint classification safety/efficacy study
Intervention model single group assignment
Masking open label
Primary purpose treatment
Arm
(Experimental)
8 weekly intra-venous (I.V.) infusions, 1 x 300mg and 7 x 1000mg
ofatumumab
8 weekly intra-venous (i.v.) infusions, 1 x 300mg and 7 x 1000mg

Primary Outcomes

Measure
Number of Participants With Objective Response
time frame: 6-month period from start of treatment (up to Week 24). Participants were followed up for an average of 2.8 months.
Number of Participants Classified as Responders and Non-responders for Objective Response
time frame: 6-month period from start of treatment (up to Week 24). Participants were followed up for an average of 2.8 months.

Secondary Outcomes

Measure
Duration of Response
time frame: From date of randomization of the first participant to when the last participant completed the 6-month follow up visit. Participants were followed up for an average of 2.8 months.
Progression-free Survival (PFS)
time frame: From date of randomization of the first participant to when the last participant completed the 6-month follow up visit. Participants were followed up for an average of 2.8 months.
Time to Next Diffuse Large B-Cell Lymphoma (DLBCL) Therapy
time frame: From date of randomization of the first participant to when the last participant completed the 6-month follow up visit. Participants were followed up for an average of 2.8 months.
Overall Survival (OS)
time frame: Participants were followed up for an average of 2.8 months
Number of Participants With Positive Human Anti-human Antibodies (HAHA) at Screening and at Visits 12, 13, 14, and 18
time frame: Screening visit (=<14 days before treatment start), Visit 12 (Month 6), Visit 13 (Month 9), Visit 14 (Month 12), and Visit 18 (Month 24)
Median Percent Change From Baseline in CD45+CD19+ and CD45+CD20+ Cells in the Peripheral Blood at the Indicated Visits
time frame: Baseline and Visit 10 (Week 8), Visit 11 (Week 11), Visit 12 (Month 6), Visit 13 (Month 9), Visit 14 (Month 12), Visit 15 (Month 15), Visit 16 (Month 18), Visit 17 (Month 21), Visit 18 (Month 24)
Number of Participants Who Experienced at Least One Adverse Event (AE)
time frame: Participants were followed up for an average of 2.8 months from start of treatment.
Percent Change From Screening in Complement (CH50) Levels
time frame: Screening and post-baseline visits (last visit was to occur 24 months post first dose)
AUC(0-inf) and AUC(0-168) for Ofatumumab at the Eighth Infusion
time frame: Visit 9 (Week 7; up to 11 months after last dose)
Cmax and Ctrough for Ofatumumab at the First and Eighth Infusions
time frame: Visit 2 (Week 0) and Visit 9 (Week 7)
Half-life (T1/2) for Ofatumumab at the Eighth Infusion
time frame: Visit 9 (Week 7; up to 11 months after last dose)
Clearance (CL) of Ofatumumab at the Eighth Infusion
time frame: Visit 9 (Week 7; up to 11 months after last dose)
Volume of Distribution at Steady State (Vss) of Ofatumumab at the Eighth Infusion
time frame: Visit 9 (Week 7; up to 11 months after the last dose)

Eligibility Criteria

Male or female participants at least 18 years old.

Inclusion Criteria: Patients with DLBCL - and relapse after complete remission or disease progression after partial remission who are ineligible for autologous stem cell transplantation - and relapse after complete remission or disease progression after partial remission following autologous stem cell transplantation.

Additional Information

Official title 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
Trial information was received from ClinicalTrials.gov and was last updated in July 2014.
Information provided to ClinicalTrials.gov by GlaxoSmithKline.