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NCT05951959 · ClinicalTrials.gov registry record · Phase 2
A Study of Acalabrutinib Plus Venetoclax and Rituximab in Participants With Treatment Naïve Mantle Cell Lymphoma
A Phase 2 study of Mantle Cell Lymphoma (MCL), sponsored by AstraZeneca.
- Active
- Registry status
- Phase 2
- Development phase
- 108
- Enrollment target
- 20
- Study locations
NCT05951959: Active Phase 2 study of Mantle Cell Lymphoma (MCL), sponsored by AstraZeneca.
NCT05951959 is a Phase 2 study of Mantle Cell Lymphoma (MCL) that is active but no longer recruiting, run by AstraZeneca. The registered enrollment target is 108 participants, below the 197-participant average among 9 other Mantle Cell Lymphoma (MCL) trials with a reported enrollment target (45% lower). The trial reports 20 study locations across 11 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT05951959, a Phase 2 study of Mantle Cell Lymphoma (MCL), is active but no longer recruiting, sponsored by AstraZeneca.
- ACTIVE NOT RECRUITING
- Registry status
- Phase 2
- Development phase
- 108 participants
- Enrollment target
- 20
- Study locations
Study Summary
TrAVeRse is a multicentre, open-label, Phase II study of AVR in treatment naïve MCL participants. The primary objective will be to assess the rate of MRD-negative CR at end of induction after completing 13 cycles of AVR. Participants achieving an MRD-negative CR at the end of AVR induction will be randomised to continued acalabrutinib or observation. Participants who progress during observation may receive retreatment with acalabrutinib
Primary Outcome
MRD-negative CR rate is defined as the proportion of participants who achieved MRD-negativity in peripheral blood by NGS at a threshold of 10-5 while in CR per the Lugano Classification for NHL at the end of AVR induction
Conditions Studied
Interventions
- DRUG Venetoclax
- DRUG Rituximab
- DRUG Acalabrutinib
Study Locations (20)
Other
- Research Site - Heidelberg
- Research Site - Kogarah
- Research Site - Nedlands
- Research Site - Sydney
- Research Site - Porto Alegre
- Research Site - Rio de Janeiro
- Research Site - São Paulo
- Research Site - São Paulo
- Research Site - Gdynia
Ontario
- Research Site - Barrie
- Research Site - Toronto
New Jersey
- Research Site - Hackensack
New York
- Research Site - Stony Brook
Ohio
- Research Site - Cleveland
Pennsylvania
- Research Site - Philadelphia
Texas
- Research Site - Houston
Alberta
- Research Site - Edmonton
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 108 participants |
| Start Date | 2023-12-13 |
| Est. Completion | 2028-07-07 |
| Phase | Phase 2 |
What the registry record for NCT05951959 still lists
NCT05951959 is an interventional study that assigns participants to a tested intervention. The registered 108 participants enrollment target is mid-sized for trials with a published cap, below the 197-participant average among 9 other Mantle Cell Lymphoma (MCL) trials with a reported enrollment target (45% lower).
The record links to 1 condition, with Mantle Cell Lymphoma (MCL) appearing as the primary indexed condition, and to 3 interventions - of which Venetoclax is the first listed.
NCT05951959 names 20 study sites across 11 states, led by Other, Ontario, New Jersey.
Frequently Asked Questions
What is clinical trial NCT05951959 about?
NCT05951959 is a clinical study titled "A Study of Acalabrutinib Plus Venetoclax and Rituximab in Participants With Treatment Naïve Mantle Cell Lymphoma". TrAVeRse is a multicentre, open-label, Phase II study of AVR in treatment naïve MCL participants. The primary objective will be to assess the rate of MRD-negative CR at end of induction after completing 13 cycles of AVR. Participants achieving an MRD-negative CR at the end of AVR induction will be r...
What is the current status of trial NCT05951959?
This trial is currently active not recruiting. It is a Phase 2 study. The enrollment target is 108 participants. The study started on 2023-12-13. Estimated completion is 2028-07-07.
What conditions does trial NCT05951959 study?
This clinical trial studies the following conditions: Mantle Cell Lymphoma (MCL).
What interventions are being tested in trial NCT05951959?
The interventions under investigation include: Venetoclax (DRUG), Rituximab (DRUG), Acalabrutinib (DRUG).
Who is sponsoring clinical trial NCT05951959?
This trial is sponsored by AstraZeneca, which has 1,285 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT05951959 being conducted?
This trial has 20 study locations across New Jersey, New York, Ohio, Pennsylvania, Texas. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
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Where NCT05951959's enrollment target sits among peer trials
108 6th of 9 higher than 4 of 9 other Mantle Cell Lymphoma (MCL) trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Mantle Cell Lymphoma (MCL) 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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