GATE1: A Multicenter Phase II Study of Pirtobrutinib, Rituximab and Venetoclax Combination Therap… (NCT06522386) | Clinical Trial Compass
Active — Not RecruitingPhase 2
GATE1: A Multicenter Phase II Study of Pirtobrutinib, Rituximab and Venetoclax Combination Therapy for Patients With Previously Untreated Mantle Cell Lymphoma
United States50 participantsStarted 2025-01-30
Plain-language summary
Primary Objectives:
To estimate the percent of participants who achieve a best response of complete response by the end of the PRV combination therapy in the induction therapy phase in patients with previously untreated MCL.
Who can participate
Age range18 Years
SexALL
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Inclusion criteria
✓. Age ≥ 18 years old.
✓. Confirmed pathology diagnosis of MCL with t(11;14)(q13;q32) translocation and/or cyclin D1 overexpression (e.g., positive immunohistochemistry staining).
✓. MCL cells are CD20 positive (e.g., positive staining on immunohistochemistry or flow cytometry).
✓. No prior MCL-directed systemic treatment (such as chemotherapy, immunotherapy, targeted therapy, and cellular therapy) or radiotherapy.
✓. Have a clinical indication to treat (e.g., B symptoms, or symptomatic or progressive lymphadenopathy or hepatosplenomegaly, or cytopenia caused by MCL, etc.).
✓. ECOG performance status (PS) 0-2 (Appendix I).
✓. Evaluable disease, i.e., ANY of the following:
✓. Meet ALL following criteria in lab values obtained ≤ 14 days prior to registration:
Exclusion criteria
✕. CNS involvement by MCL (e.g., any parenchymal, leptomeningeal, CSF, cranial nerve, or spinal cord or nerve root involvement).
✕. Pregnant or plan to become pregnant during study treatment or within 1 month following the last dose of pirtobrutinib and/or venetoclax or within 12 months following the last dose of rituximab; or breast-feeding or plan to breastfeed during study treatment or within 1 week following the last dose of pirtobrutinib and/or venetoclax or within 6 months following the last dose of rituximab.
What they're measuring
1
Incidence of Adverse Events, Graded According to National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) Version (v) 5.0
Timeframe: Through study completion; an average of 1 year.
. Malabsorption syndrome or other condition that precludes enteral route of administration.
✕. Any of the following medication requirement or recent use:
✕. Co-morbid systemic illnesses or other severe concurrent disease which, in the judgment of the investigator, would make the patient inappropriate for entry into this study or interfere significantly with the proper assessment of safety and toxicity of the prescribed regimens.
✕. History of a bleeding disorder (e.g., hemophilia, von Willebrand disease, etc.) or active bleeding.
✕. Active or recent infections, including but not limited to:
✕. Uncontrolled cardiovascular disease including but not limited to: