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NCT03623373 · ClinicalTrials.gov registry record · Phase 2
Acalabrutinib With Bendamustine / Rituximab Followed by Cytarabine / Rituximab for Untreated Mantle Cell Lymphoma
A Phase 2 study of Mantle Cell Lymphoma, sponsored by Washington University School of Medicine.
- Completed
- Registry status
- Phase 2
- Development phase
- 13
- Enrollment target
- 1
- Study location
NCT03623373 is a Phase 2 study of Mantle Cell Lymphoma that has completed, run by Washington University School of Medicine. The registered enrollment target is 13 participants, below the 104-participant average among 102 other Mantle Cell Lymphoma trials with a reported enrollment target (87% lower). The trial reports 1 study location across 1 state.
The verdict
NCT03623373, a Phase 2 study of Mantle Cell Lymphoma, has completed, sponsored by Washington University School of Medicine.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 13 participants
- Enrollment target
- 1
- Study location
Study Summary
This study is designed to evaluate the efficacy and safety of acalabrutinib plus bendamustine and rituximab followed by acalabrutinib plus cytarabine and rituximab in subjects with treatment naïve mantle cell lymphoma (MCL), as a preparation for a larger cooperative group trial with the goal of achieving a standard induction regimen for MCL in transplant eligible patients. The investigators hypothesize that the addition of acalabrutinib to BR/CR regimen will prove safe and increase the complete response (CR) rate as well as minimal residual disease (MRD) negativity pre-transplant, thus improving clinical outcomes.
Conditions Studied
Interventions
- DRUG Rituximab
- DRUG Cytarabine
- DRUG Acalabrutinib
- PROCEDURE Leukapheresis
- DRUG Bendamustine
Study Locations (1)
Missouri
- Washington University School of Medicine - St Louis
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 13 participants |
| Start Date | 2018-11-29 |
| Est. Completion | 2025-04-14 |
| Phase | Phase 2 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT03623373
The ClinicalTrials.gov registry entry for NCT03623373 describes a study currently listed as completed, categorized as Phase 2. The registered enrollment target is 13 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 (87% lower). The listed sponsor is Washington University School of Medicine, which has 1,502 total studies on file at ClinicalTrials.gov.
The record links to 1 condition, with Mantle Cell Lymphoma appearing as the primary indexed condition, and to 5 interventions - of which Rituximab is the first listed.
NCT03623373 reports 1 study location spanning 1 distinct geographic area - top geographies include Missouri.
Frequently Asked Questions
What is clinical trial NCT03623373 about?
NCT03623373 is a clinical study titled "Acalabrutinib With Bendamustine / Rituximab Followed by Cytarabine / Rituximab for Untreated Mantle Cell Lymphoma". This study is designed to evaluate the efficacy and safety of acalabrutinib plus bendamustine and rituximab followed by acalabrutinib plus cytarabine and rituximab in subjects with treatment naïve mantle cell lymphoma (MCL), as a preparation for a larger cooperative group trial with the goal of achi...
What is the current status of trial NCT03623373?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 13 participants. The study started on 2018-11-29. Estimated completion is 2025-04-14.
What conditions does trial NCT03623373 study?
This clinical trial studies the following conditions: Mantle Cell Lymphoma.
What interventions are being tested in trial NCT03623373?
The interventions under investigation include: Rituximab (DRUG), Cytarabine (DRUG), Acalabrutinib (DRUG), Leukapheresis (PROCEDURE), Bendamustine (DRUG).
Who is sponsoring clinical trial NCT03623373?
This trial is sponsored by Washington University School of Medicine, which has 1,502 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT03623373 being conducted?
This trial has 1 study location across Missouri. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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Read our methodology - how this data is sourced, computed, and verified.
Related
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