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Ofatumumab Plus Bendamustine in Frontline and Relapsed Chronic Lymphocytic Leukaemia (CLL)
NCT01520922 · View on ClinicalTrials.gov ↗
Study Summary
This is a Phase II, open label, single arm, multi-centre study investigating the safety and efficacy of ofatumumab plus bendamustine in subjects with untreated or relapsed CLL. Each subject from the screening phase who is willing to participate in the study and is found eligible according to the inclusion and exclusion criteria will enter the treatment phase and will receive a maximum of 6 Cycles of study treatment (ofatumumab plus bendamustine). All subjects will receive 3 Cycles of study treatment (Cycles 1, 2 and 3). Eligibility to receive study treatment for Cycles 4, 5 and 6 will be assessed following the 3rd Cycle. Subjects who have achieved at least stable disease with acceptable toxicity following 3 Cycles of treatment will be eligible to continue to receive study treatments for a maximum of 3 further Cycles. In case of progressive disease, at, or at any time after the start of Cycle 4, subjects must discontinue further study treatment and move into the study's follow-up period. During the treatment phase, all eligible subjects will be allocated to receive the following study treatments: 1. Subjects with Untreated CLL: Up to 6 monthly intravenous infusions of ofatumumab (Cycle 1: 300 mg Day 1 and 1000 mg Day 8; subsequent Cycles: 1000 mg at Day 1 every 28 Days) in combination with up to 6 Cycles of intravenously infused bendamustine (90 mg/m2, Days 1 and 2, every 28 Days). 2. Subjects with Relapsed CLL: Up to 6 monthly intravenous infusions of ofatumumab (Cycle 1: 300 mg Day 1 and 1000 mg Day 8; subsequent Cycles: 1000 mg at Day 1 every 28 Days) in combination with up to 6 Cycles of intravenously infused bendamustine (70 mg/m2, Days 1 and 2, every 28 Days). The studies primary endpoint is overall response rate (ORR) as determined by Investigator evaluation. The ORR is the percentage of subjects achieving an objective response (i.e., partial response or better), using the IWCLL updated NCI-WG guidelines. Response assessments are planned at the following t
Conditions Studied
Interventions
- DRUG Bendamustine
- BIOLOGICAL Ofatumumab
Study Locations (20)
Other
- Novartis Investigative Site — Brussels
- Novartis Investigative Site — Ghent
- Novartis Investigative Site — Leuven
- Novartis Investigative Site — Brno
- Novartis Investigative Site — Hradec Králové
- Novartis Investigative Site — Olomouc
- Novartis Investigative Site — Prague
- Novartis Investigative Site — Athens
- Novartis Investigative Site — Thessaloniki
Florida
- Novartis Investigative Site — Fort Myers
- Novartis Investigative Site — St. Petersburg
Lazio
- Novartis Investigative Site — Rome
- Novartis Investigative Site — Rome
Arizona
- Novartis Investigative Site — Tuscon
Colorado
- Novartis Investigative Site — Aurora
Tennessee
- Novartis Investigative Site — Nashville
Utah
- Novartis Investigative Site — Ogden
Emilia-Romagna
- Novartis Investigative Site — Modena
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 99 participants |
| Start Date | 2012-03 |
| Est. Completion | 2015-11 |
| Phase | Phase 2 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT01520922
The ClinicalTrials.gov registry entry for NCT01520922 describes a study currently listed as completed. It is categorized as Phase 2, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 99 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Novartis Pharmaceuticals, which has 792 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.
The record links to 2 conditions, with Chronic Lymphocytic Leukemia (CLL) appearing as the primary indexed condition, and to 2 interventions — of which Bendamustine is the first listed. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.
Geographic footprint matters for practical reasons: NCT01520922 reports 20 study locations spanning 10 distinct geographic areas — top geographies include Other, Florida, Lazio. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.
Frequently Asked Questions
What is clinical trial NCT01520922 about?
NCT01520922 is a clinical study titled "Ofatumumab Plus Bendamustine in Frontline and Relapsed Chronic Lymphocytic Leukaemia (CLL)". This is a Phase II, open label, single arm, multi-centre study investigating the safety and efficacy of ofatumumab plus bendamustine in subjects with untreated or relapsed CLL. Each subject from the screening phase who is willing to participate in the study and is found eligible according to the in...
What is the current status of trial NCT01520922?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 99 participants. The study started on 2012-03. Estimated completion is 2015-11.
What conditions does trial NCT01520922 study?
This clinical trial studies the following conditions: Chronic Lymphocytic Leukemia (CLL), Leukaemia, Lymphocytic, Chronic. These conditions were identified from the trial registry and reflect the primary focus areas of the research.
What interventions are being tested in trial NCT01520922?
The interventions under investigation include: Bendamustine (DRUG), Ofatumumab (BIOLOGICAL). Each intervention is being evaluated for safety and efficacy as part of this clinical study.
Who is sponsoring clinical trial NCT01520922?
This trial is sponsored by Novartis Pharmaceuticals, which has 792 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.
Where is trial NCT01520922 being conducted?
This trial has 20 study locations across Arizona, Colorado, Florida, Tennessee, Utah. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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