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NCT05495464 · ClinicalTrials.gov registry record · Early Phase 1
A Pilot "Window-3" Study of Acalabrutinib Plus Rituximab Followed by Brexucabtagene Autoleucel Therapy in Patients With Previously Untreated High-risk Mantle Cell Lymphoma
A Early Phase 1 study of Lymphoma and Mantle Cell Lymphoma, sponsored by M.D. Anderson Cancer Center.
- Active
- Registry status
- Early Phase 1
- Development phase
- 22
- Enrollment target
- 1
- Study location
NCT05495464: Active Early Phase 1 study of Lymphoma and Mantle Cell Lymphoma, sponsored by M.D. Anderson Cancer Center.
NCT05495464 is a Early Phase 1 study of Lymphoma and Mantle Cell Lymphoma that is active but no longer recruiting, run by M.D. Anderson Cancer Center. The registered enrollment target is 22 participants, below the 484-participant average among 299 other Lymphoma trials with a reported enrollment target (95% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT05495464, a Early Phase 1 study of Lymphoma and Mantle Cell Lymphoma, is active but no longer recruiting, sponsored by M.D. Anderson Cancer Center.
- ACTIVE NOT RECRUITING
- Registry status
- Early Phase 1
- Development phase
- 22 participants
- Enrollment target
- 1
- Study location
Study Summary
To learn if giving acalabrutinib, rituximab, and brexucabtagene autoleucel to patients with previously untreated high-risk mantle cell lymphoma (MCL) can help to control the disease.
Primary Outcome
Unacceptable toxicity is defined as any grade 3 or higher treatment related toxicities happened within 30 days after CAR T-cell infusion. Will monitor the unacceptable toxicity for two patient cohorts together using the Bayesian stopping boundaries calculated based on beta-binomial distribution. The regimen will be considered excessively toxic if the unacceptable toxicity rate at 30 days after CAR T infusion is above 30%. Frequency tables will be used to summarize categorical variables such as t
Conditions Studied
Interventions
- DRUG Cyclophosphamide
- DRUG Rituximab
- DRUG Acalabrutinib
- DRUG Fludarabine Phosphate
- OTHER Brexucabtagene Autoleucel
Study Locations (1)
Texas
- M D Anderson Cancer Center - Houston
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 22 participants |
| Start Date | 2022-11-18 |
| Est. Completion | 2027-03-31 |
| Phase | Early Phase 1 |
What the registry record for NCT05495464 still lists
NCT05495464 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 22 participants, a relatively small participant target, below the 484-participant average among 299 other Lymphoma trials with a reported enrollment target (95% lower).
The record links to 2 conditions, with Lymphoma appearing as the primary indexed condition, and to 5 interventions - of which Cyclophosphamide is the first listed.
NCT05495464 reports a single indexed study location in Texas.
Frequently Asked Questions
What is clinical trial NCT05495464 about?
NCT05495464 is a clinical study titled "A Pilot "Window-3" Study of Acalabrutinib Plus Rituximab Followed by Brexucabtagene Autoleucel Therapy in Patients With Previously Untreated High-risk Mantle Cell Lymphoma". To learn if giving acalabrutinib, rituximab, and brexucabtagene autoleucel to patients with previously untreated high-risk mantle cell lymphoma (MCL) can help to control the disease.
What is the current status of trial NCT05495464?
This trial is currently active not recruiting. It is a Early Phase 1 study. The enrollment target is 22 participants. The study started on 2022-11-18. Estimated completion is 2027-03-31.
What conditions does trial NCT05495464 study?
This clinical trial studies the following conditions: Lymphoma, Mantle Cell Lymphoma.
What interventions are being tested in trial NCT05495464?
The interventions under investigation include: Cyclophosphamide (DRUG), Rituximab (DRUG), Acalabrutinib (DRUG), Fludarabine Phosphate (DRUG), Brexucabtagene Autoleucel (OTHER).
Who is sponsoring clinical trial NCT05495464?
This trial is sponsored by M.D. Anderson Cancer Center, which has 2,692 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT05495464 being conducted?
This trial has 1 study location across Texas. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
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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 NCT05495464's enrollment target sits among peer trials
22 243rd of 299 higher than 57 of 299 other Lymphoma trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other 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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