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NCT00748189 · ClinicalTrials.gov registry record · Phase 3
Ofatumumab + Chlorambucil vs Chlorambucil Monotherapy in Previously Untreated Patients With Chronic Lymphocytic Leukemia
A Phase 3 study, sponsored by Novartis Pharmaceuticals.
- Terminated
- Registry status
- Phase 3
- Development phase
- 447
- Enrollment target
NCT00748189: Clinical Trial Phase 3 study, sponsored by Novartis Pharmaceuticals.
NCT00748189 is a Phase 3 study that was terminated before completion, run by Novartis Pharmaceuticals. The registered enrollment target is 447 participants, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (42% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00748189, a Phase 3 study, was terminated before completion, sponsored by Novartis Pharmaceuticals.
- TERMINATED
- Registry status
- Phase 3
- Development phase
- 447 participants
- Enrollment target
Study Summary
The purpose of this study was to evaluate the safety and efficacy of ofatumumab added to chlorambucil in patients with untreated Chronic Lymphocytic Leukemia.
Primary Outcome
PFS is defined as the interval of time between the date of randomization and the earlier of the date of disease progression (PD) and the date of death due to any cause. PD requires at least one of the following: lymphadenopathy, appearance of any new lesion such as enlarged lymph nodes (\>1.5 cm) spleen or liver or other infiltrates or an increase by 50% or more in the greatest diameter of any previous site; an increase by 50% or more in the previously noted enlargement of the liver or spleen, a
Interventions
- DRUG chlorambucil, tablets
- DRUG ofatumumab (GSK1841157) infusion
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 447 participants |
| Start Date | 2008-12-22 |
| Est. Completion | 2018-05-17 |
| Phase | Phase 3 |
Why NCT00748189 stopped before completion
NCT00748189 is an interventional study that assigns participants to a tested intervention. The registered 447 participants enrollment target is mid-sized for trials with a published cap, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (42% lower).
The record links to 0 conditions, and to 2 interventions - of which chlorambucil, tablets is the first listed.
NCT00748189 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT00748189 about?
NCT00748189 is a clinical study titled "Ofatumumab + Chlorambucil vs Chlorambucil Monotherapy in Previously Untreated Patients With Chronic Lymphocytic Leukemia". The purpose of this study was to evaluate the safety and efficacy of ofatumumab added to chlorambucil in patients with untreated Chronic Lymphocytic Leukemia.
What is the current status of trial NCT00748189?
This trial is currently terminated. It is a Phase 3 study. The enrollment target is 447 participants. The study started on 2008-12-22. Estimated completion is 2018-05-17.
What interventions are being tested in trial NCT00748189?
The interventions under investigation include: chlorambucil, tablets (DRUG), ofatumumab (GSK1841157) infusion (DRUG).
Who is sponsoring clinical trial NCT00748189?
This trial is sponsored by Novartis Pharmaceuticals, which has 1,375 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT00748189's enrollment target sits among peer trials
447 864th of 2000 higher than 1,137 of 2,000 other Phase 3 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 3 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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