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NCT01039376 · ClinicalTrials.gov registry record · Phase 3
Ofatumumab Maintenance Treatment vs No Further Treatment in Relapsed CLL Responding to Induction Therapy
A Phase 3 study, sponsored by Novartis Pharmaceuticals.
- Terminated
- Registry status
- Phase 3
- Development phase
- 480
- Enrollment target
NCT01039376 is a Phase 3 study that was terminated before completion, run by Novartis Pharmaceuticals. The registered enrollment target is 480 participants.
The verdict
NCT01039376, a Phase 3 study, was terminated before completion, sponsored by Novartis Pharmaceuticals.
- TERMINATED
- Registry status
- Phase 3
- Development phase
- 480 participants
- Enrollment target
Study Summary
The purpose of this study was to determine if maintenance therapy with ofatumumab would prolong remission in patients with CLL who have responded to second or third line treatment. This study would also evaluate the safety of ofatumumab maintenance compared to observation (the current standard of care). This study was co-developed with the HOVON and NORDIC CLL group and would be conducted as a collaborative effort with GSK.
Interventions
- OTHER Observation
- BIOLOGICAL Ofatumumab
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 480 participants |
| Start Date | 2010-05-06 |
| Est. Completion | 2018-06-26 |
| Phase | Phase 3 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT01039376
The ClinicalTrials.gov registry entry for NCT01039376 describes a study currently listed as terminated, categorized as Phase 3. The registered enrollment target is 480 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Novartis Pharmaceuticals, which has 1,375 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 2 interventions - of which Observation is the first listed.
NCT01039376 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT01039376 about?
NCT01039376 is a clinical study titled "Ofatumumab Maintenance Treatment vs No Further Treatment in Relapsed CLL Responding to Induction Therapy". The purpose of this study was to determine if maintenance therapy with ofatumumab would prolong remission in patients with CLL who have responded to second or third line treatment. This study would also evaluate the safety of ofatumumab maintenance compared to observation (the current standard of ca...
What is the current status of trial NCT01039376?
This trial is currently terminated. It is a Phase 3 study. The enrollment target is 480 participants. The study started on 2010-05-06. Estimated completion is 2018-06-26.
What interventions are being tested in trial NCT01039376?
The interventions under investigation include: Observation (OTHER), Ofatumumab (BIOLOGICAL).
Who is sponsoring clinical trial NCT01039376?
This trial is sponsored by Novartis Pharmaceuticals, which has 1,375 total clinical trials registered on ClinicalTrials.gov.
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