Phase 2
N=59
Ofatumumab (Humax-CD20) With CHOP (Cyclophosphamide,Doxorubicin, Vincristine, Predisolone) in Follicular Lymphoma (FL) Patients
Lymphoma, Follicular
Bottom Line
View on ClinicalTrials.gov: NCT00494780 ↗Enrolled (actual)
59
Serious AEs
26.7%
Results posted
Aug 2011
Primary outcome: Primary: Number of Participants With the Indicated Overall Best Response (OBR) at Visit 26 (3 Months After the Last Infusion of Ofatumumab) — 6; 9; 10; 7 participants
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- Ofatumumab (Drug); Cyclophosphamide (Drug); Doxorubicin (Drug); Vincristine (Drug); Prednisolone, Prednisone or equivalent (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 the Indicated Overall Best Response (OBR) at Visit 26 (3 Months After the Last Infusion of Ofatumumab) |
6; 9; 10; 7; 10; 13 | — |
| SECONDARY Number of Participants With Complete Remission (CR) at Visit 26 |
6; 9 | — |
| SECONDARY Median Percent Change From Visit 1 (Screening, Week -2) in Tumor Size at Visit 33 (24 Months After the Last Infusion of Ofatumumab) |
-100; -100; -100; -100 | — |
| SECONDARY Time to New Anti-follicular Lymphoma (FL) Therapy |
47.2; NA | — |
| SECONDARY Progression-Free Survival (PFS) |
27.6; NA | — |
| SECONDARY Duration of Response |
21.0; 25.0 | — |
| SECONDARY Percent Change From Visit 1 (Screening) in Peripheral CD19+ and CD20+ Cell Counts at Visit 33 (24 Months After the Last Infusion of Ofatumumab) |
154.1; 307.9; 154.1; 307.9 | — |
| SECONDARY Number of Participants Who Experienced Any Adverse Event (AEs) From First Treatment to Visit 33 (24 Months After Last Infusion) |
29; 29 | — |
| SECONDARY Number of Participants With Positive Human Anti-human Antibodies (HAHA) at Visits 1, 28, and 33 |
0; 0; 0; 0; 0; 0 | — |
| SECONDARY Median Percent Change From Visit 1 (Screening) in Serum Complement (CH50) Levels at Visit 22 |
42.0; 23.2 | — |
| SECONDARY Number of Participants Who Had a Conversion of BCL-2 t(14;18)-Positive to Negative by Polymerase Chain Reaction (PCR) in Peripheral Blood and Bone Marrow Aspirate and Its Durability Post-therapy |
— | — |
| SECONDARY Cmax and Ctrough at the Sixth Infusion (Week 15, Visit 22) |
232; 497; 78.5; 188 | — |
| SECONDARY AUC(0-inf) and AUC(0-504) After the Sixth Infusion (Week 15, Visit 22) |
177133; 399676; 79500; 168866 | — |
| SECONDARY Half Life (t1/2) of Ofatumumab at the Sixth Infusion (Week 15, Visit 22) |
652; 644 | — |
| SECONDARY CL After the Sixth Infusion (Week 15, Visit 22) |
6.29; 5.92 | — |
| SECONDARY Vss at the Sixth Infusion (Week 15, Visit 22) |
5.15; 5.32 | — |
Summary
To investigate the efficacy in two dose regimens of ofatumumab in combination with CHOP (cyclophosphamide,doxorubicin, vincristine,prednisolone) in previously untreated patients with Follicular Lymphoma (FL)
Eligibility Criteria
Inclusion Criteria
- Patient with Follicular Lymphoma (FL)
- Confirmed diagnosis of Follicular lymphoma
- 18 years or above
- Verbal and written information about the study
Exclusion Criteria
- No previous treatment for Follicular Lymphoma
- Clinical suspicion that the Follicular Lymphoma has transformed to aggressive lymphoma
- Several diseases such as malignancies etc.
- Screening laboratory values
- Current participation in any other interventional clinical study
- Breast feeding women or pregnant women
- Women of childbearing potential not willing to use adequate contraception
Data sourced from ClinicalTrials.gov (NCT00494780). 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.