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NCT00494780 · ClinicalTrials.gov registry record · Phase 2
Ofatumumab (Humax-CD20) With CHOP (Cyclophosphamide,Doxorubicin, Vincristine, Predisolone) in Follicular Lymphoma (FL) Patients
A Phase 2 study, sponsored by GlaxoSmithKline.
- Completed
- Registry status
- Phase 2
- Development phase
- 59
- Enrollment target
NCT00494780: Completed Phase 2 study, sponsored by GlaxoSmithKline.
NCT00494780 is a Phase 2 study that has completed, run by GlaxoSmithKline. The registered enrollment target is 59 participants, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (56% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00494780, a Phase 2 study, has completed, sponsored by GlaxoSmithKline.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 59 participants
- Enrollment target
Study 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)
Primary Outcome
Based on standardized response criteria for NHL, responders included participants with CR (complete disappearance of all detectable clinical and radiographic evidence of disease), CRu (more than a 75% decrease in LN size compared to baseline), and PR (\>=50% decrease in LN size and evidence of new lesions). Non-responders included participants with stable disease (SD; \<50% decrease in LN size from baseline) and progressive disease (PD; \>=50% increase in LN size and evidence of new lesions).
Interventions
- DRUG Cyclophosphamide
- DRUG Doxorubicin
- DRUG Vincristine
- DRUG Ofatumumab
- DRUG Prednisolone, Prednisone or equivalent
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 59 participants |
| Start Date | 2007-06 |
| Est. Completion | 2010-09 |
| Phase | Phase 2 |
What the finished NCT00494780 record still lists
NCT00494780 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 59 participants, a relatively small participant target, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (56% lower).
The record links to 0 conditions, and to 5 interventions - of which Cyclophosphamide is the first listed.
NCT00494780 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT00494780 about?
NCT00494780 is a clinical study titled "Ofatumumab (Humax-CD20) With CHOP (Cyclophosphamide,Doxorubicin, Vincristine, Predisolone) in Follicular Lymphoma (FL) Patients". 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)
What is the current status of trial NCT00494780?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 59 participants. The study started on 2007-06. Estimated completion is 2010-09.
What interventions are being tested in trial NCT00494780?
The interventions under investigation include: Cyclophosphamide (DRUG), Doxorubicin (DRUG), Vincristine (DRUG), Ofatumumab (DRUG), Prednisolone, Prednisone or equivalent (DRUG).
Who is sponsoring clinical trial NCT00494780?
This trial is sponsored by GlaxoSmithKline, which has 1,345 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT00494780's enrollment target sits among peer trials
59 1133rd of 2000 higher than 866 of 2,000 other Phase 2 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 2 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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