Ofatumumab and Bendamustine Followed by Maintenance Ofatumumab for Rituximab Relapsed Indolent B-cell Non-Hodgkin's Lymphoma (B-NHL)
Public ClinicalTrials.gov record NCT01294579. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.
Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.
Official title
A Phase II Open-Label Study of Ofatumumab and Bendamustine Followed by Maintenance Ofatumumab for Indolent B-cell Non-Hodgkin's Lymphoma (B-NHL) Which Has Relapsed After Rituximab or a Rituximab Containing Therapy
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
The purpose of this phase II open label study was is to evaluate the safety and efficacy of ofatumumab and bendamustine followed by maintenance ofatumumab in subjects with indolent B-NHL who had relapsed after Rituximab treatment. A maximum of 53 subjects at least 18 years old with Small lymphocytic, lymphoplasmacytic, marginal zone lymphoma, or follicular lymphoma; Grades 1, 2 and 3a, would have been enrolled (34 in Stage 1 and 19 in Stage 2). Subjects should have had Rituximab-sensitive disease, defined as a Partial Remission (PR) or Complete Remission (CR) to the last rituximab-containing therapy lasting at least 6 months following completion of therapy or subjects should have relapsed or have had disease progression following response to prior rituximab-based therapy a Eastern Cooperative Oncology Group (ECOG) Performance status of 0 1 or 2. During the induction phase, ofatumumab 1000 mg IV on day 1 of each cycle (cycles 1-6) were followed by Bendamustine 90 mg/m2 IV on days 1, 2 of each cycle (cycles 1-6).During the maintenance phase, subjects with a PR or CR after the induction phase received ofatumumab 1000 mg IV every 2 months for 2 years.
Study identification
- NCT ID
- NCT01294579
- Recruitment status
- Completed
- Study type
- Interventional
- Phase
- Phase 2
- Enrollment
- 49 participants
Conditions and interventions
Conditions
Eligibility (public fields only)
- Age range
- 18 Years and older
- Sex
- All
- Healthy volunteers
- Healthy volunteers not accepted
This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.
Study timeline
- Start date
- May 17, 2011 (Actual)
- Primary completion
- Dec 20, 2016 (Actual)
- Completion
- Dec 20, 2016 (Actual)
- Last update posted
- Aug 9, 2018
2011 – 2016
United States locations
- U.S. sites
- 22
- U.S. states
- 13
- U.S. cities
- 22
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| Novartis Investigative Site | Chandler | Arizona | 85224 | — |
| Novartis Investigative Site | Burbank | California | 91505 | — |
| Novartis Investigative Site | Fresno | California | 93720 | — |
| Novartis Investigative Site | Oxnard | California | 93030 | — |
| Novartis Investigative Site | Aurora | Colorado | 80045 | — |
| Novartis Investigative Site | Orange Park | Florida | 32073 | — |
| Novartis Investigative Site | Burlington | Massachusetts | 01805 | — |
| Novartis Investigative Site | Omaha | Nebraska | 68198-9200 | — |
| Novartis Investigative Site | Las Vegas | Nevada | 89169 | — |
| Novartis Investigative Site | Cary | North Carolina | 27518 | — |
| Novartis Investigative Site | Charlotte | North Carolina | 28204 | — |
| Novartis Investigative Site | Raleigh | North Carolina | 27607 | — |
| Novartis Investigative Site | Kettering | Ohio | 45429 | — |
| Novartis Investigative Site | Eugene | Oregon | 97401 | — |
| Novartis Investigative Site | Charleston | South Carolina | 29414 | — |
| Novartis Investigative Site | Greenville | South Carolina | 29601 | — |
| Novartis Investigative Site | San Antonio | Texas | 78229 | — |
| Novartis Investigative Site | Sherman | Texas | 75090 | — |
| Novartis Investigative Site | Tyler | Texas | 75702 | — |
| Novartis Investigative Site | Waco | Texas | 76712 | — |
| Novartis Investigative Site | Vancouver | Washington | 98684 | — |
| Novartis Investigative Site | Yakima | Washington | 98902 | — |
Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT01294579, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
- What this page does not do
- No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
- Where the data comes from
- Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
- Last refresh
- Last update posted Aug 9, 2018 · Synced Oct 26, 2026
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Open the official record
The complete public registry record, listed eligibility criteria, and available contact information for NCT01294579 live on ClinicalTrials.gov.