Phase 2 Study of BTKi-Rituximab Induction Followed by Glofitamab Consolidation in High Risk Untreated MCL Patients - WINDOW-4 Study

Part of paid clinical trials in Houston, Texas.

Sponsor
M.D. Anderson Cancer Center
Study ID
NCT07257055
Phase
PHASE2
Status
Recruiting
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Conditions

  • BTKi
  • Glofitamab
  • MCL
  • Phase 2 Study
  • Rituximab

Eligibility Criteria

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

Interventions

Study Details

to learn if giving glofitamab after treatment with BTKi-rituximab can help to control high-risk MCL.

Key Dates

First listed
Dec 2, 2025
Start date
Apr 1, 2026
Status verified
May 2026
Primary completion
Nov 24, 2028
Completion
Nov 24, 2030

Study Design

Enrollment
30 participants (estimated)
Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: 1-Induction
    Phase 2 Induction Treatment with BTKi-R - Rituximab/Ruxience + Acalabrutinib/Zanubrutinib
  • Experimental: 2-Consolidation
    Phase 2 Consolidation Treatment with Glofitamab
  • Experimental: 3-Maintenance
    Phase 2 Maintenance Treatment with BTKi-R - Rituximab/Ruxience + Acalabrutinib/Zanubrutinib

Primary Outcome Measure

Safety and adverse events (AEs) [ Time Frame: Through study completion; an average of 1 year ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
MD Anderson Cancer CenterHoustonTexas77030
Preetesh Jain, MD
[email protected]
713-563-8786
Preetesh Jain, MD (PRINCIPAL_INVESTIGATOR)

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MD Anderson Cancer Center· Houston, TX

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