Actively Recruiting
Phase 2 Study of BTKi-Rituximab Induction Followed by Glofitamab Consolidation in High Risk Untreated Mantle Cell Lymphoma Patients - WINDOW-4 Study
Led by M.D. Anderson Cancer Center · Updated on 2026-05-20
30
Participants Needed
1
Research Sites
104 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating if giving glofitamab after initial treatment with BTKi-rituximab can help control high-risk mantle cell lymphoma (MCL) in patients who have not been treated before. This phase 2 study aims to determine how well patients achieve minimal residual disease (MRD) negativity and complete response after receiving these treatments. The study also seeks to assess overall response, progression-free survival, overall survival, and the safety of glofitamab as a consolidation therapy. Participants will first receive induction treatment with BTKi-Rituximab, which includes oral Acalabrutinib or Zanubrutinib and intravenous Rituximab. Those who achieve complete response will then receive consolidation treatment with intravenous glofitamab over 12 cycles. After consolidation, maintenance treatment with BTKi-Rituximab will continue. This treatment sequence is designed to evaluate the combined effects of these therapies on high-risk MCL. During the study, participants will undergo regular evaluations including disease assessments, laboratory tests, and safety monitoring for adverse events throughout approximately one year. Researchers will measure treatment response using criteria such as metabolic response by imaging and track the occurrence of side effects. The study involves a non-randomized design and includes follow-up to monitor long-term outcomes and treatment safety.
CONDITIONS
Brief Title
Phase 2 Study of BTKi-Rituximab Induction Followed by Glofitamab Consolidation in High Risk Untreated MCL Patients - WINDOW-4 Study
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Confirmed diagnosis of mantle cell lymphoma with CD20 positivity and specific genetic markers or overexpression of cyclin D1.
- Life expectancy of at least 12 weeks.
- Newly diagnosed, untreated, high-risk MCL eligible for BTKi-R and glofitamab therapy.
- High-risk features including specific histology, high Ki-67, genetic mutations, complex karyotype, bulky nodal or spleen involvement, or high-risk MIPI score.
- Able to swallow capsules and tablets without difficulty.
- Age 18 years or older.
- Measurable disease by imaging or spleen involvement.
- ECOG performance status of 1 or less.
- Well-controlled cardiovascular conditions with adequate heart function.
- Adequate blood counts and liver and kidney function.
- Agrees to use effective contraception if of childbearing potential.
- Willing to comply with study procedures and hospitalization upon first glofitamab dose.
- Achieved complete metabolic response to initial therapy.
- Agrees to refrain from blood donation during and after study treatment.
You will not qualify if you...
- Relapsed or refractory mantle cell lymphoma.
- Disease limited to bone marrow or gastrointestinal tract only without measurable disease unless leukemic phase with high-risk features.
- Pregnant or breastfeeding.
- Primary refractory to BTKi-R treatment.
- Recent investigational drug use.
- Life-threatening illness or organ dysfunction that increases risk.
- Known HIV infection.
- History of hemophagocytic lymphohistiocytosis or active Epstein-Barr virus infection.
- Positive COVID-19 test within 7 days prior to enrollment.
- Does not meet high-risk MCL features.
- Active hepatitis B or C infection.
- Recent or active malignancies other than certain treated skin or cervical cancers.
- Central nervous system involvement with lymphoma or related disorders.
- Uncontrolled CNS disorders.
- Active bleeding disorders or recent stroke.
- Uncontrolled autoimmune disorders.
- Gastrointestinal conditions affecting medication absorption.
- Need for certain anticoagulants or corticosteroid use above specified doses.
- Immunodeficiency or recent systemic immunosuppression.
- Use of strong CYP3A inhibitors or inducers near study start.
- Significant cardiovascular disease or uncontrolled hypertension.
- Active infection requiring systemic treatment.
- Recent live vaccinations.
- Severe allergic reactions to study drugs.
- Concurrent participation in another therapeutic clinical trial.
- Inability to swallow oral medications or recent major surgery without recovery.
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
Duration - Duration of induction treatment as per protocol
Participants receive induction treatment with BTKi-Rituximab (Acalabrutinib or Zanubrutinib plus Rituximab) to achieve complete response.
Duration - Duration of 12 cycles of Glofitamab
Participants receive consolidation treatment with 12 cycles of Glofitamab.
Duration - Duration of maintenance treatment as per protocol
Participants receive maintenance treatment with BTKi-Rituximab (Acalabrutinib or Zanubrutinib plus Rituximab).
Trial Site Locations
Total: 1 location
1
MD Anderson Cancer Center
Houston, Texas, United States, 77030
Actively Recruiting
Research Team
P
Preetesh Jain, MD
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NON_RANDOMIZED
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
3
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