Actively Recruiting

Phase 2
Age: 18Years +
All Genders
NCT07257055

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

Led by M.D. Anderson Cancer Center · Updated on 2026-04-16

30

Participants Needed

1

Research Sites

242 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

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

CONDITIONS

Official Title

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

Who Can Participate

Age: 18Years +
All Genders

Eligibility Criteria

Eligible

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 12 weeks or more
  • Newly diagnosed, untreated high-risk mantle cell lymphoma eligible for BTKi-R and glofitamab therapy
  • High-risk features including specific histology, genetic mutations, bulky disease, or high-risk MIPI score approved by study PI
  • Ability and willingness to participate in all study evaluations and procedures, including swallowing capsules and tablets
  • Age 18 years or older at consent
  • Measurable disease by PET-CT or CT scan, or spleen involvement
  • ECOG performance status of 1 or lower
  • Well-controlled cardiovascular conditions with ejection fraction 50% or higher and cardiology clearance
  • Adequate blood counts and organ function as specified
  • Agreement to use effective contraception during and after treatment as per protocol
  • Willingness to comply with hospitalization for first glofitamab dose
  • Achieved complete metabolic response to first-line BTKi-rituximab treatment
  • Agreement to refrain from donating blood during and for 12 months after treatment
Not Eligible

You will not qualify if you...

  • Radiologically confirmed relapsed or refractory disease
  • Bone marrow or gastrointestinal only disease without measurable disease unless leukemic phase with high-risk features
  • Pregnant or breastfeeding females
  • Primary refractory to BTKi-R therapy
  • Recent investigational drug use within 30 days or 5 half-lives
  • Life-threatening illness or organ dysfunction compromising safety
  • Known HIV infection
  • History of hemophagocytic lymphohistiocytosis or active Epstein-Barr virus infection
  • Positive COVID-19 test within 7 days prior to enrollment
  • Lack of high-risk features for MCL
  • Active hepatitis B or C infection or positive viral PCR without clearance
  • Prior malignancy requiring active treatment except certain skin and in situ cancers disease-free for 3 years
  • Central nervous system involvement or uncontrolled CNS disorders
  • Active bleeding disorders or recent intracranial bleed or stroke
  • Uncontrolled autoimmune hemolytic anemia or idiopathic thrombocytopenic purpura
  • Significant gastrointestinal disease affecting drug absorption unless cleared
  • Use of warfarin or vitamin K antagonists or active treatment for clotting disorders unless reviewed
  • High dose corticosteroid use longer than 2 weeks
  • Active primary immunodeficiency or recent autoimmune disease requiring immunosuppression without clearance
  • Use of strong CYP3A inhibitors or inducers close to dosing
  • Significant cardiovascular disease including recent myocardial infarction or arrhythmias without clearance
  • Active infection requiring systemic treatment or recent live vaccines
  • Other serious medical or psychiatric conditions posing risk or interfering with study
  • Hypersensitivity or anaphylaxis to study drugs or components
  • Concurrent participation in another therapeutic clinical trial
  • Inability to swallow oral medication or significant gastrointestinal disease limiting absorption
  • Major surgery within 28 days without full recovery
  • History of severe allergic reactions to related antibody therapies
  • Immunodeficiency or systemic immunosuppressant therapy within 28 days except specified exceptions
  • Participants with inactive hepatitis B must follow reactivation prophylaxis protocols

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 1 location

1

MD Anderson Cancer Center

Houston, Texas, United States, 77030

Actively Recruiting

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Research Team

P

Preetesh Jain, MD

CONTACT

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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