NCT07257055

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

• Status: Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 30 (estimated)
• Sponsor: M.D. Anderson Cancer Center · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

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

Detailed description

Primary Objective To determine the rate of minimal residual disease (MRD) negativity following treatment with 12 cycles of glofitamab in participants with high risk MCL after achieving CR on standard first line treatment with BTKi (Acalabrutinib or Zanubrutinib)-rituximab Secondary Objectives To determine overall response rate (ORR), complete response (CR), Early MRD negative response, progression-free survival (PFS), overall survival (OS), and evaluate the safety of glofitamab as consolidation treatment for MCL

Conditions

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

Interventions

Type	Name	Description
DRUG	Acalabrutinib	Given by po
DRUG	Rituximab	Given by IV
DRUG	Glofitamab	Given by IV

Timeline

• Start date: 2026-04-01
• Primary completion: 2028-11-24
• Completion: 2030-11-24
• First posted: 2025-12-02
• Last updated: 2026-04-16

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study