A Study of Acalabrutinib Plus Venetoclax and Rituximab in Participants With Treatment Naïve Mantle Cell Lymphoma

Part of paid clinical trials in Hackensack, New Jersey.

Sponsor
AstraZeneca
Study ID
NCT05951959
Phase
PHASE2
Status
Active Not Recruiting

Conditions

  • Mantle Cell Lymphoma (MCL)

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Acalabrutinib — DRUG
    Investigational Product
  • Venetoclax — DRUG
    Investigator Product
  • Rituximab — DRUG
    Investigator Product

Study Details

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

Key Dates

Start date
Dec 13, 2023
Status verified
May 2026
Primary completion
Oct 31, 2028
Completion
Oct 31, 2028

Study Design

Enrollment
108 participants (actual)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: Acalabrutinib + Venetoclax + Rituximab
    Acalabrutinib + Venetoclax + Rituximab (AVR)

Primary Outcome Measure

MRD-negative CR rate [ Time Frame: At the end of AVR induction, i.e., following completion of Cycle 13 (each cycle is 28 days) ]

Locations (5)

FacilityCityStateZIPSite coordinators
Research SiteHackensackNew Jersey07601-
Research SiteStony BrookNew York11794-
Research SiteClevelandOhio44195-
Research SitePhiladelphiaPennsylvania19104-
Research SiteHoustonTexas77030-

Find similar trials in Hackensack, NJ

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Research Site· Hackensack, NJResearch Site· Stony Brook, NYResearch Site· Cleveland, OHResearch Site· Philadelphia, PAResearch Site· Houston, TX

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