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NCT06553872 · ClinicalTrials.gov registry record · Phase 2
Phase 2 Open Label Randomized Study of Pirtobrutinib and Brexucabtagene Autoleucel in R/R MCL
A Phase 2 study of Mantle Cell Lymphoma, sponsored by H. Lee Moffitt Cancer Center and Research Institute.
- Recruiting
- Registry status
- Phase 2
- Development phase
- 60
- Enrollment target
- 3
- Study locations
NCT06553872: Recruiting Phase 2 study of Mantle Cell Lymphoma, sponsored by H. Lee Moffitt Cancer Center and Research Institute.
NCT06553872 is a Phase 2 study of Mantle Cell Lymphoma that is actively recruiting participants, run by H. Lee Moffitt Cancer Center and Research Institute. The registered enrollment target is 60 participants, below the 104-participant average among 102 other Mantle Cell Lymphoma trials with a reported enrollment target (42% lower). The trial reports 3 study locations across 2 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT06553872, a Phase 2 study of Mantle Cell Lymphoma, is actively recruiting participants, sponsored by H. Lee Moffitt Cancer Center and Research Institute.
- RECRUITING
- Registry status
- Phase 2
- Development phase
- 60 participants
- Enrollment target
- 3
- Study locations
Study Summary
This is a phase 2, open-label, randomized, multicenter clinical trial in patients with relapsed/refractory mantle cell lymphoma (R/R MCL) who meet the criteria for standard-of-care FDA label for CD19 CAR T-cell therapy with brexucabtagene autoleucel (brexu-cel).
Primary Outcome
The one-sample log-rank test will be used to determine if there's a statistically significant difference in PFS in patients treated on this trial of pirto plus brexucel compared to a historical control.
Conditions Studied
Interventions
- DRUG Pirtobrutinib
- DRUG Brexucabtagene Autoleucel
Study Locations (3)
Florida
- Univ of Miami - Sylvester Comprehensive Cancer Center - Miami
- Moffitt Cancer Center - Tampa
California
- Stanford Cancer Center - Stanford
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 60 participants |
| Start Date | 2024-08-23 |
| Est. Completion | 2029-08 |
| Phase | Phase 2 |
What NCT06553872 shows while recruiting
NCT06553872 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 60 participants, a relatively small participant target, below the 104-participant average among 102 other Mantle Cell Lymphoma trials with a reported enrollment target (42% lower).
The record links to 1 condition, with Mantle Cell Lymphoma appearing as the primary indexed condition, and to 2 interventions - of which Pirtobrutinib is the first listed.
NCT06553872 reports a single indexed study location in Florida, California.
Frequently Asked Questions
What is clinical trial NCT06553872 about?
NCT06553872 is a clinical study titled "Phase 2 Open Label Randomized Study of Pirtobrutinib and Brexucabtagene Autoleucel in R/R MCL". This is a phase 2, open-label, randomized, multicenter clinical trial in patients with relapsed/refractory mantle cell lymphoma (R/R MCL) who meet the criteria for standard-of-care FDA label for CD19 CAR T-cell therapy with brexucabtagene autoleucel (brexu-cel).
What is the current status of trial NCT06553872?
This trial is currently recruiting. It is a Phase 2 study. The enrollment target is 60 participants. The study started on 2024-08-23. Estimated completion is 2029-08.
What conditions does trial NCT06553872 study?
This clinical trial studies the following conditions: Mantle Cell Lymphoma.
What interventions are being tested in trial NCT06553872?
The interventions under investigation include: Pirtobrutinib (DRUG), Brexucabtagene Autoleucel (DRUG).
Who is sponsoring clinical trial NCT06553872?
This trial is sponsored by H. Lee Moffitt Cancer Center and Research Institute, which has 502 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT06553872 being conducted?
This trial has 3 study locations across California, Florida. 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 NCT06553872's enrollment target sits among peer trials
60 35th of 102 higher than 65 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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-
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Glofitamab With Pirtobrutinib for Relapsed or Refractory Mantle Cell Lymphoma
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Phase II Study of Pirtobrutinib With Venetoclax In Relapsed-Refractory MCL (Mantle Cell Lymphoma) Patients
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Phase II Study of Pirtobrutinib, Rituximab (PR) in Previously Untreated Low and Intermediate Risk MCL (Mantle Cell Lymphoma) Patients
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-
Sonrotoclax, Rituximab, and Zanubrutinib in Treating Participants With Chronic Lymphocytic Leukemia, Small Lymphocytic Lymphoma, and Mantle Cell Lymphoma
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