Phase 2
Completed N=81
Ofatumumab in Patients With Relapsed/Progressive Diffused Large B-Cell Lymphoma (DLBCL) Ineligible for or Relapse/Progression After Transplant
Source: ClinicalTrials.gov NCT00622388 ↗Enrolled (actual)
81
Serious AEs
40.7%
Results posted
Sep 2011
Primary outcomePrimary: Number of Participants With Objective Response — 9 participants
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
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Participants With Objective Response |
9 | — |
| PRIMARY Number of Participants Classified as Responders and Non-responders for Objective Response |
2; 7; 14; 34; 24 | — |
| SECONDARY Duration of Response |
9.5 | — |
| SECONDARY Progression-free Survival (PFS) |
2.5 | — |
| SECONDARY Time to Next Diffuse Large B-Cell Lymphoma (DLBCL) Therapy |
NA | — |
| SECONDARY Overall Survival (OS) |
— | — |
| SECONDARY Number of Participants With Positive Human Anti-human Antibodies (HAHA) at Screening and at Visits 12, 13, 14, and 18 |
0; 0; 0; 0; 0; 0 | — |
| SECONDARY Median Percent Change From Baseline in CD45+CD19+ and CD45+CD20+ Cells in the Peripheral Blood at the Indicated Visits |
-100.0; -100.0; -100.0; -100.0; -100.0; -60.7 | — |
| SECONDARY Number of Participants Who Experienced at Least One Adverse Event (AE) |
78 | — |
| SECONDARY Percent Change From Screening in Complement (CH50) Levels |
— | — |
| SECONDARY AUC(0-inf) and AUC(0-168) for Ofatumumab at the Eighth Infusion |
720388; 110193 | — |
| SECONDARY Cmax and Ctrough for Ofatumumab at the First and Eighth Infusions |
109; 839; 497 | — |
| SECONDARY Half-life (T1/2) for Ofatumumab at the Eighth Infusion |
637 | — |
| SECONDARY Clearance (CL) of Ofatumumab at the Eighth Infusion |
9.1 | — |
| SECONDARY Volume of Distribution at Steady State (Vss) of Ofatumumab at the Eighth Infusion |
8.3 | — |
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.
Data sourced from ClinicalTrials.gov (NCT00622388). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.