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New treatment option for Phase 2 Study
Official title Phase 2 Study of BTKi-Rituximab Induction Followed by Glofitamab Consolidation in High Risk Untreated MCL Patients - WINDOW-4 Study
ClinicalTrials.gov ID: NCT07257055
What this study is testing
What is Acalabrutinib?
Acalabrutinib is an investigational medicine, being studied as a potential treatment for phase 2 study.
Also referred to as Zanubrutinib.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- to learn if giving glofitamab after treatment with BTKi-rituximab can help to control high-risk MCL.
- Phase 2: a mid-size study of how well it works
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- Eligibility Criteria Participants must meet the following criteria for study entry:
- Confirmed diagnosis of mantle cell lymphoma by hematopathology. MCL should have CD20 positivity (by flow or IHC in tissue or in BM) with presence of...
- Participants should have a life expectancy \>= 12 weeks.
- Newly diagnosed, untreated, high risk participant without any prior therapy for MCL and are eligible to receive BTKi-R and glofitamab therapy.
- High risk MCL (Blastoid/pleomorphic histology, high Ki-67 (≥50%), TP53/NOTCH1/2, NSD2, UBR5, TRAF2, SP140, SMARCA4, KMT2D, BIRC3 mutated or any of...
You likely can't join if
- Having radiologically confirmed relapsed/refractory disease.
- Isolated bone marrow or GI only disease MCL participants and/or lack of any measurable disease, except if participants have leukemic phase MCL with...
- Pregnant or breast-feeding females.
- Participants who are primary refractory to BTKi-R (No response/progressive disease within first 3 months of BTKi-R)
- Received any investigational drug within 30 days or 5 half-lives (whichever is shorter) before first dose of study drug.
- Current life-threatening illness, medical condition, or organ system dysfunction which, in the Investigator's opinion, could compromise the subject's...
See the full eligibility criteria
Who can join
- Eligibility Criteria Participants must meet the following criteria for study entry:
- Confirmed diagnosis of mantle cell lymphoma by hematopathology. MCL should have CD20 positivity (by flow or IHC in tissue or in BM) with presence of chromosome translocation t (11;14), (q13;q32) and/or overexpression of...
- Participants should have a life expectancy \>= 12 weeks.
- Newly diagnosed, untreated, high risk participant without any prior therapy for MCL and are eligible to receive BTKi-R and glofitamab therapy.
- High risk MCL (Blastoid/pleomorphic histology, high Ki-67 (≥50%), TP53/NOTCH1/2, NSD2, UBR5, TRAF2, SP140, SMARCA4, KMT2D, BIRC3 mutated or any of these mutations or more than 2 mutations with some evidence of...
What rules you out
- Having radiologically confirmed relapsed/refractory disease.
- Isolated bone marrow or GI only disease MCL participants and/or lack of any measurable disease, except if participants have leukemic phase MCL with any high risk features.
- Pregnant or breast-feeding females.
- Participants who are primary refractory to BTKi-R (No response/progressive disease within first 3 months of BTKi-R)
- Received any investigational drug within 30 days or 5 half-lives (whichever is shorter) before first dose of study drug.
- Current life-threatening illness, medical condition, or organ system dysfunction which, in the Investigator's opinion, could compromise the subject's safety or put the study at risk.
- Known HIV infection.
- Known history of hemophagocytic lymphohistiocytosis (HLH)
- Known or suspected chronic active Epstein-Barr virus infection (clearance with infectious disease is needed to allow these participants)
- Positive SARS-CoV-2 test within 7 days prior to enrollment. Rapid antigen test result is also acceptable.
- Participants who do not meet high risk features as indicated above in inclusion.
- Hepatitis B or C serologic status: people who are hepatitis B core antibody (anti-HBc) positive and who are hepatitis B surface antigen (HBsAg) negative will need to have a negative polymerase chain reaction (PCR) and...
- Prior malignancy (or any other malignancy requiring active treatment), except for adequately treated basal cell or squamous cell skin cancer, in situ cervical cancer, in situ ca prostate, in situ melanoma (\> 5 mm...
- Central nervous system involvement with mantle cell lymphoma or with suspected or confirmed progressive multifocal leukoencephalopathy (PML). Magnetic resonance imaging (MRI) of the brain, if performed, showing evidence...
- History or presence of uncontrolled CNS disorder, such as seizure disorder, cerebrovascular ischemia/hemorrhage, dementia, cerebellar disease, cerebral edema, posterior reversible encephalopathy syndrome, or any...
- Active bleeding, history of bleeding diathesis (such as Hemophilia or Von-Willebrand disease), Any history of intracranial bleed or stroke within 6 months of first dose of study drug.
- Uncontrolled AIHA (autoimmune hemolytic anemia) or ITP (idiopathic thrombocytopenic purpura).
- Malabsorption syndrome, disease which is clinically significantly affecting gastrointestinal function, or resection of the stomach or small bowel or active ulcerative colitis, symptomatic inflammatory bowel disease, or...
- Presence of a clinically significant gastrointestinal ulcer diagnosed by endoscopy within 3 months before first dose of study drug.
- Requires anticoagulation with warfarin or equivalent vitamin K antagonist, active treatment for pulmonary embolism (PE)/ deep vein thrombosis (DVT) and persons with mechanical cardiac valves. These participants may be...
- Concomitant use of corticosteroids at \> 20 mg prednisone or equivalent per day longer than 2 weeks.
- Primary immunodeficiency which is clinically active
- History of confirmed autoimmune disease (e.g. Crohn's disease, rheumatoid arthritis, systemic lupus) resulting in end organ injury or requiring systemic immunosuppression/systemic disease modifying agents within the...
- The use of strong CYP3A inhibitors within 1 week or strong CYP3A inducers within 3 weeks of the first dose of study drug is prohibited.
- Requires treatment with strong CYP3A inhibitors or inducers.
- Clinically significant cardiovascular disease such as uncontrolled or symptomatic arrhythmias, congestive heart failure, or myocardial infarction within 6 months of Screening, or any Class 3 (moderate) or Class 4...
- NYHA Class III and IV heart failure,
- Active/symptomatic coronary artery disease,
- Myocardial infarction in the preceding 6 months,
- Significant conduction abnormalities, including but not limited to:
- Left bundle branch block,
- 2nd degree AV block type II,
- 3rd degree block,
- QT prolongation (QTc \> 500 msec),
- Sick sinus syndrome,
- Ventricular tachycardia,
- Symptomatic bradycardia (heart rate \< 50 bpm),
- Persistent and uncontrolled atrial fibrillation.
- Uncontrolled hypertension
- Uncontrolled Hypotension
- Light headedness and syncope,
- Acute infection requiring systemic anti-infective treatment systemic antibiotics, antivirals, or antifungals, or including people with positive cytomegalovirus [CMV] DNA polymerase chain reaction [PCR] within 14 days...
- Vaccinated with live, attenuated vaccines within 6 weeks of first dose of study drug.
- Any other serious medical condition including, but not limited to, clinically significant uncontrolled diabetes mellitus, COPD, renal failure, psychiatric illness or social circumstances that, in the investigator's...
- Known history of hypersensitivity or anaphylaxis to study drug(s) including active product or excipient components. 6\. Concurrent participation in another therapeutic clinical trial. 47. Is unable to swallow any oral...
- History of severe allergic or anaphylactic reactions or intolerance to anti-CD20 monoclonal antibody therapy or any bispecific antibody.
- History of immunodeficiency (except for hypogammaglobulinemia) or concurrent systemic immunosuppressant therapy (e.g., cyclosporine, tacrolimus, etc., or chronic administration glucocorticoid equivalent of \>10mg/day of...
The study team makes the final eligibility decision.
Where it's taking place
- Houston, Texas, United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Houston, Texas, United States. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.