Medical Information Only. Always consult your healthcare provider before enrolling in any clinical trial.
NCT01294579 · ClinicalTrials.gov registry record · Phase 2
Ofatumumab and Bendamustine Followed by Maintenance Ofatumumab for Rituximab Relapsed Indolent B-cell Non-Hodgkin's Lymphoma (B-NHL)
A Phase 2 study of Lymphoma, Non-Hodgkin, sponsored by Novartis Pharmaceuticals.
- Completed
- Registry status
- Phase 2
- Development phase
- 49
- Enrollment target
- 20
- Study locations
NCT01294579 is a Phase 2 study of Lymphoma, Non-Hodgkin that has completed, run by Novartis Pharmaceuticals. The registered enrollment target is 49 participants, below the 393-participant average among 56 other Lymphoma, Non-Hodgkin trials with a reported enrollment target (88% lower). The trial reports 20 study locations across 12 states.
The verdict
NCT01294579, a Phase 2 study of Lymphoma, Non-Hodgkin, has completed, sponsored by Novartis Pharmaceuticals.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 49 participants
- Enrollment target
- 20
- Study locations
Study Summary
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.
Conditions Studied
Interventions
- DRUG Bendamustine
- BIOLOGICAL Ofatumumab
Study Locations (20)
Texas
- Novartis Investigative Site - San Antonio
- Novartis Investigative Site - Sherman
- Novartis Investigative Site - Tyler
- Novartis Investigative Site - Waco
California
- Novartis Investigative Site - Burbank
- Novartis Investigative Site - Fresno
- Novartis Investigative Site - Oxnard
North Carolina
- Novartis Investigative Site - Cary
- Novartis Investigative Site - Charlotte
- Novartis Investigative Site - Raleigh
South Carolina
- Novartis Investigative Site - Charleston
- Novartis Investigative Site - Greenville
Arizona
- Novartis Investigative Site - Chandler
Colorado
- Novartis Investigative Site - Aurora
Florida
- Novartis Investigative Site - Orange Park
Massachusetts
- Novartis Investigative Site - Burlington
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 49 participants |
| Start Date | 2011-05-17 |
| Est. Completion | 2016-12-20 |
| Phase | Phase 2 |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT01294579
The ClinicalTrials.gov registry entry for NCT01294579 describes a study currently listed as completed, categorized as Phase 2. The registered enrollment target is 49 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 393-participant average among 56 other Lymphoma, Non-Hodgkin trials with a reported enrollment target (88% lower). The listed sponsor is Novartis Pharmaceuticals, which has 1,375 total studies on file at ClinicalTrials.gov.
The record links to 1 condition, with Lymphoma, Non-Hodgkin appearing as the primary indexed condition, and to 2 interventions - of which Bendamustine is the first listed.
NCT01294579 reports 20 study locations spanning 12 distinct geographic areas - top geographies include Texas, California, North Carolina.
Frequently Asked Questions
What is clinical trial NCT01294579 about?
NCT01294579 is a clinical study titled "Ofatumumab and Bendamustine Followed by Maintenance Ofatumumab for Rituximab Relapsed Indolent B-cell Non-Hodgkin's Lymphoma (B-NHL)". 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...
What is the current status of trial NCT01294579?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 49 participants. The study started on 2011-05-17. Estimated completion is 2016-12-20.
What conditions does trial NCT01294579 study?
This clinical trial studies the following conditions: Lymphoma, Non-Hodgkin.
What interventions are being tested in trial NCT01294579?
The interventions under investigation include: Bendamustine (DRUG), Ofatumumab (BIOLOGICAL).
Who is sponsoring clinical trial NCT01294579?
This trial is sponsored by Novartis Pharmaceuticals, which has 1,375 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT01294579 being conducted?
This trial has 20 study locations across Arizona, California, Colorado, Florida, Massachusetts. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
Similar trials for Lymphoma, Non-Hodgkin
Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
-
Epcoritamab-CAR T Cells for Large B-cell Lymphomas
RECRUITING · Phase 2
-
TAPUR: Testing the Use of Food and Drug Administration (FDA) Approved Drugs That Target a Specific Abnormality in a Tumor Gene in People With Advanced Stage Cancer
RECRUITING · Phase 2
-
Alpha/Beta T Cell and CD19+ B Cell Depletion in Allogeneic Stem Cell Transplantation in Patients With Malignant Diseases
RECRUITING · Phase 2
-
Tandem Stem Cell Transplantation for Non-Hodgkin's Lymphoma
ACTIVE NOT RECRUITING · Phase 2
-
Study to Evaluate the Role of Siltuximab in Treatment of Cytokine Release Syndrome (CRS) and Immune Effector Cell Associated Neurotoxicity (ICANS) Related to CAR-T Cell Therapy
ACTIVE NOT RECRUITING · Phase 2
-
A Study to Evaluate the Efficacy and Safety of JCAR017 in Adult Subjects With Relapsed or Refractory Indolent B-cell Non-Hodgkin Lymphoma (NHL)
ACTIVE NOT RECRUITING · Phase 2
Read our methodology - how this data is sourced, computed, and verified.
Related
Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.