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NCT02972840 · ClinicalTrials.gov registry record · Phase 3
A Study of BR Alone Versus in Combination With Acalabrutinib in Subjects With Previously Untreated MCL
A Phase 3 study of Lymphoma, Mantle-Cell, sponsored by Acerta Pharma.
- Active
- Registry status
- Phase 3
- Development phase
- 635
- Enrollment target
- 20
- Study locations
NCT02972840: Active Phase 3 study of Lymphoma, Mantle-Cell, sponsored by Acerta Pharma.
NCT02972840 is a Phase 3 study of Lymphoma, Mantle-Cell that is active but no longer recruiting, run by Acerta Pharma. The registered enrollment target is 635 participants, above the 146-participant average among 7 other Lymphoma, Mantle-Cell trials with a reported enrollment target (335% higher). The trial reports 20 study locations across 15 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT02972840, a Phase 3 study of Lymphoma, Mantle-Cell, is active but no longer recruiting, sponsored by Acerta Pharma.
- ACTIVE NOT RECRUITING
- Registry status
- Phase 3
- Development phase
- 635 participants
- Enrollment target
- 20
- Study locations
Study Summary
This study is evaluating the efficacy of acalabrutinib in combination with bendamustine and rituximab (BR) compared with placebo plus BR in subjects with previously untreated mantle cell lymphoma.
Primary Outcome
Defined as the time from the date of randomization until disease progression (assessed by the IRC per the Lugano Classification for NHL) or death from any cause, whichever occurs first.
Conditions Studied
Interventions
- DRUG Placebo
- DRUG Rituximab
- DRUG Acalabrutinib
- DRUG Bendamustine
Study Locations (20)
California
- Research Site - Downey
- Research Site - Santa Monica
Florida
- Research Site - Tallahassee
- Research Site - West Palm Beach
Missouri
- Research Site - Kansas City
- Research Site - St Louis
New Jersey
- Research Site - Hackensack
- Research Site - Morristown
New York
- Research Site - Hawthorne
- Research Site - Lake Success
Arizona
- Research Site - Tucson
Connecticut
- Research Site - New Haven
District of Columbia
- Research Site - Washington D.C.
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 635 participants |
| Start Date | 2017-04-05 |
| Est. Completion | 2027-02-15 |
| Phase | Phase 3 |
What the registry record for NCT02972840 still lists
NCT02972840 is an interventional study that assigns participants to a tested intervention. The registered 635 participants enrollment target is mid-sized for trials with a published cap, above the 146-participant average among 7 other Lymphoma, Mantle-Cell trials with a reported enrollment target (335% higher).
The record links to 1 condition, with Lymphoma, Mantle-Cell appearing as the primary indexed condition, and to 4 interventions - of which Placebo is the first listed.
NCT02972840 names 20 study sites across 15 states, led by California, Florida, Missouri.
Frequently Asked Questions
What is clinical trial NCT02972840 about?
NCT02972840 is a clinical study titled "A Study of BR Alone Versus in Combination With Acalabrutinib in Subjects With Previously Untreated MCL". This study is evaluating the efficacy of acalabrutinib in combination with bendamustine and rituximab (BR) compared with placebo plus BR in subjects with previously untreated mantle cell lymphoma.
What is the current status of trial NCT02972840?
This trial is currently active not recruiting. It is a Phase 3 study. The enrollment target is 635 participants. The study started on 2017-04-05. Estimated completion is 2027-02-15.
What conditions does trial NCT02972840 study?
This clinical trial studies the following conditions: Lymphoma, Mantle-Cell.
What interventions are being tested in trial NCT02972840?
The interventions under investigation include: Placebo (DRUG), Rituximab (DRUG), Acalabrutinib (DRUG), Bendamustine (DRUG).
Who is sponsoring clinical trial NCT02972840?
This trial is sponsored by Acerta Pharma, which has 38 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT02972840 being conducted?
This trial has 20 study locations across Arizona, California, Connecticut, District of Columbia, Florida. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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