Clinical trial NCT00622388: Ofatumumab in Patients With Relapsed/Progressive Diffused Large B-Cell Lymphoma (DLBCL) Ineligible for or Relapse/Progression After Transplant
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Lymphoma, Large-Cell, Diffuse
Lead sponsor: GlaxoSmithKline
Sponsor class: INDUSTRY
First posted: 2008-02-25
Enrollment: 81
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief 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


Eligibility criteria: 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.

Primary outcomes:
measure: Number of Participants With Objective Response
timeFrame: 6-month period from start of treatment (up to Week 24)
measure: Number of Participants Classified as Responders and Non-responders for Objective Response
timeFrame: 6-month period from start of treatment (up to Week 24)
Secondary outcomes:
measure: Duration of Response
timeFrame: From date of start of treatment to 2 years or withdrawal
measure: Progression-free Survival (PFS)
timeFrame: From date of start of treatment to 2 years or withdrawal
measure: Time to Next Diffuse Large B-Cell Lymphoma (DLBCL) Therapy
timeFrame: From date of start of treatment to 5 years or withdrawal
measure: Overall Survival (OS)
timeFrame: From date of start of treatment to 5 years or withdrawal
measure: Number of Participants With Positive Human Anti-human Antibodies (HAHA) at Screening and at Visits 12, 13, 14, and 18
timeFrame: Screening visit (=<14 days before treatment start), Visit 12 (Month 6), Visit 13 (Month 9), Visit 14 (Month 12), and Visit 18 (Month 24)
measure: Median Percent Change From Baseline in CD45+CD19+ and CD45+CD20+ Cells in the Peripheral Blood at the Indicated Visits
timeFrame: 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), Visit 19 (Month 30), Visit 20 (Month 36)
measure: Number of Participants Who Experienced at Least One Adverse Event (AE)
timeFrame: Time frame is from date of start of treatment to 2 years or withdrawal
measure: Percent Change From Screening in Complement (CH50) Levels
timeFrame: Screening and post-baseline visits (last visit was to occur 24 months post first dose)
measure: AUC(0-inf) and AUC(0-168) for Ofatumumab at the Eighth Infusion
timeFrame: Visit 9 (Week 7; up to 11 months after last dose)
measure: Cmax and Ctrough for Ofatumumab at the First and Eighth Infusions
timeFrame: Visit 2 (Week 0) and Visit 9 (Week 7)
measure: Half-life (T1/2) for Ofatumumab at the Eighth Infusion
timeFrame: Visit 9 (Week 7; up to 11 months after last dose)
measure: Clearance (CL) of Ofatumumab at the Eighth Infusion
timeFrame: Visit 9 (Week 7; up to 11 months after last dose)
measure: Volume of Distribution at Steady State (Vss) of Ofatumumab at the Eighth Infusion
timeFrame: Visit 9 (Week 7; up to 11 months after the last dose)
Other outcomes:
Locations:
city: London
country: United Kingdom
facility: GSK Investigational Site
Study officials:
affiliation: GlaxoSmithKline
name: GSK Clinical Trials
role: STUDY_DIRECTOR
References:
citation: Coiffier B, Radford J, Bosly A, Martinelli G, Verhoef G, Barca G, Davies A, Decaudin D, Gallop-Evans E, Padmanabhan-Iyer S, Van Eygen K, Wu KL, Gupta IV, Lin TS, Goldstein N, Jewell RC, Winter P, Lisby S; 415 study investigators. A multicentre, phase II trial of ofatumumab monotherapy in relapsed/progressive diffuse large B-cell lymphoma. Br J Haematol. 2013 Nov;163(3):334-42. doi: 10.1111/bjh.12537. Epub 2013 Aug 23.