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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: Completed Phase 3 study of Mantle Cell Lymphoma and Non-Hodgkin's Lymphoma, sponsored by Cephalon.
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. According to ClinicalTrials.gov, the official US trial registry.
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).
Primary Outcome
On Day 2 of Cycle 1, three electrocardiograms (ECGs) were collected 15 minutes prior to any study drug administration. The baseline ECG interval value was obtained by averaging these 3 ECGs, and was compared to the average of the 3 ECGs taken on treatment with bendamustine at the end of the infusion.
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 |
What the finished NCT01073163 record still lists
NCT01073163 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 54 participants, a relatively small participant target, below the 104-participant average among 102 other Mantle Cell Lymphoma trials with a reported enrollment target (48% lower).
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 names 20 study sites across 14 states, led by 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.
Learn More About Clinical Trials
Similar trials for Mantle Cell Lymphoma
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 NCT01073163's enrollment target sits among peer trials
54 39th of 102 higher than 64 of 102 other Mantle Cell Lymphoma trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Mantle Cell 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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