Phase 2
N=116
HuMax-CD20 i(Ofatumumab) n Follicular Lymphoma (FL) Patients Refractory to Rituximab
Lymphoma, Follicular
Bottom Line
View on ClinicalTrials.gov: NCT00394836 ↗Enrolled (actual)
116
Serious AEs
16.8%
Results posted
Dec 2011
Primary outcome: Primary: Number of Participants With Objective Response (OR) — 0; 1; 2; 0 participants
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- Ofatumumab (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- GlaxoSmithKline
- Primary completion
- Apr 2009
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Participants With Objective Response (OR) |
0; 1; 2; 0; 2; 8 | — |
| PRIMARY Number of Participants Classified as Responders and Non-responders for Objective Response (OR) |
0; 1; 2; 0; 2; 8 | — |
| SECONDARY Duration of Response |
6.0; 6.0 | — |
| SECONDARY Progression-Free Survival |
3.2; 6.0 | — |
| SECONDARY Time to Next Follicular Lymphoma (FL) Therapy |
4.2; 7.0 | — |
| SECONDARY Overall Survival |
NA; NA | — |
| SECONDARY 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 |
5.50; -7.20; -2.10; -8.10; -20.30; -16.10 | — |
| SECONDARY Percent Change From Baseline (Visit 2) in CD19+ and CD20+ Cells in Peripheral Blood at Visits 11 and 12 |
-100.00; -80.1; -100.00; -100.00; -48.80; -19.00 | — |
| SECONDARY Number of Participants With Conversion and no Conversion of BCL2 Positive to BCL2 Negative in Peripheral Blood |
2; 6; 6; 15; 3; 10 | — |
| SECONDARY Number of Participants Who Experienced Any Adverse Event From First Treatment (Visit 2) to Visit 18 (Month 24) |
30; 79 | — |
| SECONDARY Number of Participants With Positive Human Anti-human Antibodies (HAHA) at Visits 1, 12, 13, and 14 |
0; 0; 0; 0; 0; 0 | — |
| SECONDARY Complement (CH50) Levels at Visit 1 and at the End of Infusion at Visit 2 |
57.00; 54.00; 49.00; 49.50 | — |
| SECONDARY Number of Participants Classified as Responders for Fragment C Receptor (FcR) Polymorphism (Poly.) |
NA; NA; NA; NA; NA; NA | — |
| SECONDARY Ctrough and Cmax at the Eighth Infusion (Visit 9, Week 7) |
183; 447; 479; 879 | — |
| SECONDARY AUC(0-inf) and AUC(0-168) After the Eighth Infusion (Visit 9, Week 7) |
327715; 566717; 71513; 113622 | — |
| SECONDARY t1/2 After the Eighth Infusion (Visit 9, Week 7) |
444; 443 | — |
| SECONDARY CL After the Eighth Infusion (Visit 9, Week 7) |
7.0; 8.8 | — |
| SECONDARY Vss After the Eighth Infusion (Visit 9, Week 7) |
4414; 5408 | — |
Summary
A Single-Arm, International, Multi-Center Trial of HuMax-CD20 (Ofatumumab), a Fully Human Monoclonal Anti-CD20 Antibody, in Patients With Follicular Lymphoma Who Are Refractory to Rituximab as Monotherapy or in Combination With Chemotherapy
Eligibility Criteria
Inclusion Criteria
- Patient with follicular lymphoma grade 1 - 2
- Refractory to rituximab given as monotherapy or in combination with any chemotherapy or to rituximab given as maintenance treatment following R-chemo, defined as:
- failure to achieve at least PR to rituximab given as monotherapy or in combination with any chemotherapy; or,
- disease progression while on rituximab (either given as monotherapy or in combination with any chemotherapy or during rituximab maintenance treatment following R-chemo); or,
- disease progression in responders within 6 months of the last dose of rituximab (either given as monotherapy or in combination with any chemotherapy or after rituximab maintenance treatment schedule following R-chemo)
- Tumor verified to be CD20+ positive from excisional lymph node biopsy
- CT scan in screening phase (based on local evaluation) showing:
- 2 or more clearly demarcated lesions with a largest diameter ≥ 1.5 cm, or
- 1 clearly demarcated lesion with a largest diameter ≥ 2,0 cm
- ECOG Performance Status of 0, 1, or 2
- Age ≥ 18 years
- Following receipt of verbal and written information about the study, the patient must provide signed informed consent before any study related activity is carried out
Exclusion Criteria
- Previous autologous stem cell transplantation within 6 months
- Previous allogeneic stem cell transplantation
- More than 1 previous radio immunotherapy regimen
- Received radio immunotherapy within 3 months
- Received any Anti-cancer treatment within 4 weeks
- Received monoclonal antibodies, other than rituximab within 3 months
- Patients previously treated with anti-CD20 monoclonal antibodies, other than rituximab
- Life expectancy less than 6 months
Data sourced from ClinicalTrials.gov (NCT00394836). 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.