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
Apply to this trial

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

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)

Find similar trials in Houston, TX

By research site
MD Anderson Cancer Center· Houston, TX

Related Studies