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NCT01234467 · ClinicalTrials.gov registry record · Phase 2
Bendamustine + Rituximab in Older Patients With Previously Untreated Diffuse Large B-cell Lymphoma
A Phase 2 study of Lymphoma and Diffuse Large B Cell Lymphoma, sponsored by UNC Lineberger Comprehensive Cancer Center.
- Completed
- Registry status
- Phase 2
- Development phase
- 23
- Enrollment target
- 7
- Study locations
NCT01234467: Completed Phase 2 study of Lymphoma and Diffuse Large B Cell Lymphoma, sponsored by UNC Lineberger Comprehensive Cancer Center.
NCT01234467 is a Phase 2 study of Lymphoma and Diffuse Large B Cell Lymphoma that has completed, run by UNC Lineberger Comprehensive Cancer Center. The registered enrollment target is 23 participants, below the 484-participant average among 299 other Lymphoma trials with a reported enrollment target (95% lower). The trial reports 7 study locations across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01234467, a Phase 2 study of Lymphoma and Diffuse Large B Cell Lymphoma, has completed, sponsored by UNC Lineberger Comprehensive Cancer Center.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 23 participants
- Enrollment target
- 7
- Study locations
Study Summary
The purpose of this research study is to learn about the safety of the treatment with a combination of bendamustine and rituximab and to find out what effects, both good and bad this treatment has on DLBCL. In addition to learning about the combination of bendamustine and rituximab, the researchers are interested in learning about how this cancer treatment affects daily activities. Subjects will be asked to complete a Geriatric Assessment (GA). GAs are designed to gather information on memory, nutritional status, mental health, and level of social support. GAs are also designed to help the health care team understand how well subjects can carry out their day to day activities and to briefly describe what other medical conditions subjects may have. This assessment will help the health care team understand a subject's "functional age" (the age a subject functions at) as compared to a subject's actual age. The researchers also want to learn how chemotherapy affects the aging process in our bodies. This is done by measuring the amount of p16 in blood. Researchers want to understand if chemotherapy changes the levels of p16 in blood.
Primary Outcome
Complete response (CR) is defined as the complete disappearance of all detectable clinical evidence of disease and disease-related symptoms if present before therapy. The complete response rate is the percentage of participants achieving a CR.
Conditions Studied
Interventions
- DRUG Rituximab
- DRUG Bendamustine
Study Locations (7)
North Carolina
- Seby B. Jones Cancer Center - Boone
- University of North Carolina at Chapel Hill - Chapel Hill
- Northeast Medical Center - Concord
- Moses Cone Regional Cancer Center - Greensboro
- Leo Jenkins Cancer Center, East Carolina University Medical Center - Greenville
- Rex Healthcare - Raleigh
- Marion L. Shepard Cancer Center - Washington
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 23 participants |
| Start Date | 2011-03 |
| Est. Completion | 2016-08 |
| Phase | Phase 2 |
What the finished NCT01234467 record still lists
NCT01234467 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 23 participants, a relatively small participant target, below the 484-participant average among 299 other Lymphoma trials with a reported enrollment target (95% lower).
The record links to 4 conditions, with Lymphoma appearing as the primary indexed condition, and to 2 interventions - of which Rituximab is the first listed.
NCT01234467 lists 7 locations in 1 state (North Carolina).
Frequently Asked Questions
What is clinical trial NCT01234467 about?
NCT01234467 is a clinical study titled "Bendamustine + Rituximab in Older Patients With Previously Untreated Diffuse Large B-cell Lymphoma". The purpose of this research study is to learn about the safety of the treatment with a combination of bendamustine and rituximab and to find out what effects, both good and bad this treatment has on DLBCL. In addition to learning about the combination of bendamustine and rituximab, the researchers ...
What is the current status of trial NCT01234467?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 23 participants. The study started on 2011-03. Estimated completion is 2016-08.
What conditions does trial NCT01234467 study?
This clinical trial studies the following conditions: Lymphoma, Diffuse Large B Cell Lymphoma, Diffuse Large Cell Lymphoma, Lymphoma, Diffuse Large-Cell.
What interventions are being tested in trial NCT01234467?
The interventions under investigation include: Rituximab (DRUG), Bendamustine (DRUG).
Who is sponsoring clinical trial NCT01234467?
This trial is sponsored by UNC Lineberger Comprehensive Cancer Center, which has 366 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT01234467 being conducted?
This trial has 7 study locations across North Carolina. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
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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.
Where NCT01234467's enrollment target sits among peer trials
23 240th of 299 higher than 58 of 299 other Lymphoma trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Lymphoma 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.
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