Medical Information Only. Always consult your healthcare provider before enrolling in any clinical trial.
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: Clinical Trial Phase 3 study, sponsored by Novartis Pharmaceuticals.
NCT01039376 is a Phase 3 study that was terminated before completion, run by Novartis Pharmaceuticals. The registered enrollment target is 480 participants, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (38% lower). According to ClinicalTrials.gov, the official US trial registry.
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.
Primary Outcome
Progression-free survival is defined as the time from randomization to the date of disease progression (PD) or death due to any cause. PD was determined by the investigator according to the definitions of response in the International Workshop for Chronic Lymphocytic Leukemia (IWCLL) updated National Cancer Institute-Sponsored Working Group (NCI-WG) guidelines. According to the guidelines, PD is characterized by at least one of the following: lymphadenopathy (appearance of any new lesion such as
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 |
Why NCT01039376 stopped before completion
NCT01039376 is an interventional study that assigns participants to a tested intervention. The registered 480 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 (38% lower).
The record links to 0 conditions, and to 2 interventions - of which Observation is the first listed.
NCT01039376 does not publish any study locations in the registry export this page uses.
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.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT01039376's enrollment target sits among peer trials
480 792nd of 2000 higher than 1,197 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
Nationwide trials with similar profiles
Cross-condition peers matched on enrollment target and registry start date, not the same-condition list above.
Similar enrollment target
- NCT01954992 · 480 participants · Phase 3
Glufosfamide Versus 5-FU in Second Line Metastatic Pancreatic Cancer
- NCT03023696 · 480 participants · NA
Can Prophylactic Foraminotomy Prevent C5 Palsy
- NCT04948060 · 480 participants · NA
Tribally Engaged Approaches to Lung Screening (TEALS)
- NCT05053230 · 480 participants · NA
A Study Evaluating the Integrative Medicine at Home (IM@HOME) Program in People With Cancer
Similar registry start date
- NCT05962346 · started 2026-12 · NA
Fetal Endoscopic Tracheal Occlusion for Congenital Diaphragmatic Hernia
- NCT07125183 · started 2026-12 · Phase 2
Study on Efficacy and Tolerability of Weekly Doxorubicin in Elderly Patients With Advanced or Metastatic Leiomyosarcoma
- NCT07292298 · started 2026-11 · Phase 2
Phase 2 Single-Arm Rectal Cancer Brachytherapy for Patients With Low-Lying Residual Adenocarcinoma After Total Neoadjuvant Therapy to Improve Organ Preservation Rates
- NCT04263285 · started 2026-10 · NA
Treatment of Depression Post-SCI