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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 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.

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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

Conditions Studied

Mantle Cell Lymphoma (MCL)

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

FieldValue
Enrollment Target 108 participants
Start Date 2023-12-13
Est. Completion 2028-07-07
Phase Phase 2

Sponsor

AstraZeneca

1,285 total trials

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Full Details on ClinicalTrials.gov ↗

What the Registry Record Tells You About NCT05951959

The ClinicalTrials.gov registry entry for NCT05951959 describes a study currently listed as active not recruiting, categorized as Phase 2. The registered enrollment target is 108 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 197-participant average among 9 other Mantle Cell Lymphoma (MCL) trials with a reported enrollment target (45% lower). The listed sponsor is AstraZeneca, which has 1,285 total studies on file at ClinicalTrials.gov.

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 reports 20 study locations spanning 11 distinct geographic areas - top geographies include 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.

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Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.