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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: Completed Phase 2 study of Mantle Cell Lymphoma, sponsored by Washington University School of Medicine.
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. According to ClinicalTrials.gov, the official US trial registry.
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.
Primary Outcome
-Stem cell mobilization success is defined as a yield of \>2x10\^6 CD34+ stem cells/kg with a maximum of 5 courses of apheresis
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 |
What the finished NCT03623373 record still lists
NCT03623373 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 13 participants, a relatively small participant target, below the 104-participant average among 102 other Mantle Cell Lymphoma trials with a reported enrollment target (87% lower).
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 a single indexed study location in 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.
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 NCT03623373's enrollment target sits among peer trials
13 95th of 102 higher than 8 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.
Source ClinicalTrials.gov registry export · 2026-08-08
-
Nemtabrutinib With Rituximab for the Treatment of Patients With Mantle Cell Lymphoma
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-
Phase 2 Open Label Randomized Study of Pirtobrutinib and Brexucabtagene Autoleucel in R/R MCL
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Acalabrutinib and Obinutuzumab for the Treatment of Previously Untreated Follicular Lymphoma or Other Indolent Non-Hodgkin Lymphomas
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Glofitamab With Pirtobrutinib for Relapsed or Refractory Mantle Cell Lymphoma
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-
Phase II Study of Pirtobrutinib, Rituximab (PR) in Previously Untreated Low and Intermediate Risk MCL (Mantle Cell Lymphoma) Patients
RECRUITING · Phase 2
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