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NCT01073163 · ClinicalTrials.gov registry record · Phase 3
Study to Assess the Effect of Treatment With Bendamustine in Combination With Rituximab on QT Interval in Patients With Advanced Indolent Non-Hodgkin's Lymphoma (NHL) or Mantle Cell Lymphoma (MCL)
A Phase 3 study of Mantle Cell Lymphoma and Non-Hodgkin's Lymphoma, sponsored by Cephalon.
- Completed
- Registry status
- Phase 3
- Development phase
- 54
- Enrollment target
- 20
- Study locations
NCT01073163 is a Phase 3 study of Mantle Cell Lymphoma and Non-Hodgkin's Lymphoma that has completed, run by Cephalon. The registered enrollment target is 54 participants, below the 104-participant average among 102 other Mantle Cell Lymphoma trials with a reported enrollment target (48% lower). The trial reports 20 study locations across 14 states.
The verdict
NCT01073163, a Phase 3 study of Mantle Cell Lymphoma and Non-Hodgkin's Lymphoma, has completed, sponsored by Cephalon.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 54 participants
- Enrollment target
- 20
- Study locations
Study Summary
The primary objective of this study is to assess the effect of treatment with bendamustine on cardiac repolarization as reflected by the rate-corrected QT interval by the Fridericia method (QTcF).
Conditions Studied
Interventions
- DRUG Rituximab
- DRUG Bendamustine
Study Locations (20)
Florida
- Memorial Cancer Institute - Hollywood
- Cancer Centers of Florida - Orlando
- MD Anderson Cancer Cnt Orlando - Orlando
California
- St. Jude Heritage Medical Group - Fullerton
- Comprehensive Cancer Center - Palm Springs
Colorado
- University of Colorado Cancer Center - Aurora
- Rocky Mountain Cancer Center - Denver
Connecticut
- The Hospital of Central Connecticut - New Britain
- Cancer Center of Central Connecticut - Southington
Missouri
- Missouri Cancer Associates - Columbia
- Kansas City Cancer Center - Kansas City
Arizona
- Hematology Oncology Physicans Extenders Group - Tucson
Arkansas
- University of Arkansas for Medical Sciences - Little Rock
Georgia
- John B Amos Cancer Center - Columbus
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 54 participants |
| Start Date | 2010-02 |
| Est. Completion | 2012-06 |
| Phase | Phase 3 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT01073163
The ClinicalTrials.gov registry entry for NCT01073163 describes a study currently listed as completed, categorized as Phase 3. The registered enrollment target is 54 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 104-participant average among 102 other Mantle Cell Lymphoma trials with a reported enrollment target (48% lower). The listed sponsor is Cephalon, which has 64 total studies on file at ClinicalTrials.gov.
The record links to 2 conditions, with Mantle Cell Lymphoma appearing as the primary indexed condition, and to 2 interventions - of which Rituximab is the first listed.
NCT01073163 reports 20 study locations spanning 14 distinct geographic areas - top geographies include Florida, California, Colorado.
Frequently Asked Questions
What is clinical trial NCT01073163 about?
NCT01073163 is a clinical study titled "Study to Assess the Effect of Treatment With Bendamustine in Combination With Rituximab on QT Interval in Patients With Advanced Indolent Non-Hodgkin's Lymphoma (NHL) or Mantle Cell Lymphoma (MCL)". The primary objective of this study is to assess the effect of treatment with bendamustine on cardiac repolarization as reflected by the rate-corrected QT interval by the Fridericia method (QTcF).
What is the current status of trial NCT01073163?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 54 participants. The study started on 2010-02. Estimated completion is 2012-06.
What conditions does trial NCT01073163 study?
This clinical trial studies the following conditions: Mantle Cell Lymphoma, Non-Hodgkin's Lymphoma.
What interventions are being tested in trial NCT01073163?
The interventions under investigation include: Rituximab (DRUG), Bendamustine (DRUG).
Who is sponsoring clinical trial NCT01073163?
This trial is sponsored by Cephalon, which has 64 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT01073163 being conducted?
This trial has 20 study locations across Arizona, Arkansas, California, Colorado, Connecticut. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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