A PHASE III, OPEN-LABEL, MULTICENTER RANDOMIZED STUDY EVALUATING GLOFITAMAB AS A SINGLE AGENT VERSUS INVESTIGATORS CHOICE IN PATIENTS WITH RELAPSED/REFRACTORY MANTLE CELL LYMPHOMA
ESTADO CLÍNICO
Reclutando
FASE/S DEL ENSAYO
Fase III
PATOLOGÍA
Coagulopatías hemorrágicas, Enfermedad de células falciformes, Linfoma Folicular, Trombosis y Anticoagulantes, Trasplante de progenitores hematopoyéticos, Terapia celular y T-CARs, --> Otros, Leucemia mieloide aguda, Leucemia linfática crónica y otros SLPC, Linfoma
FECHA DE APERTURA
Ocutbre, 2023
FECHA DE CIERRE
,
CRITERIOS DE INCLUSIÓN
PET-positive disease at screening (Deauville score of 4 or 5) according to the Recommendations for Initial Evaluation, Staging, and Response Assessment of Hodgkin and Non-Hodgkin Lymphoma: The Lugano Classification with at least one target FDG-avid lesion In rare cases of non-FDG-avid MCL with at least one measurable lesion located in an area suitable for biopsy, such as the gastrointestinal tract and a biopsy can be obtained to confirm a histological diagnosis, a participant may be eligible
Histologically-confirmed MCL, demonstrating either overexpression of cyclin D1 or the presence of t(11:14) within 12 months of study entry
Relapsed or refractory disease
At least one (>= 1) line of prior systemic therapy: - Inclusion of BTK inhibitor Prior therapy must have included a BTK inhibitor plus another systemic therapy option (e.g., a regimen containing a CD20 monoclonal antibody, prior chemotherapy, targeted agent therapy such as bortezomib, etc.) Progression or Relapse: Participants must have progressed or relapsed at any time on BTK inhibitor therapy, or failed to achieve a partial response (PR) within 12 weeks of BTK inhibitor therapy Exclusion of BTK Inhibitor Intolerance: Participants intolerant to BTK inhibitor therapy who are unable to complete at least 12 weeks of BTK inhibitor therapy should be excluded Local Therapies: Local therapies (e.g., radiotherapy) will not be considered as lines of therapy
Adequate renal function, defined as an estimated creatinine clearance 30 mL/min
Adequate hematologic function
Histologically-confirmed MCL, demonstrating either overexpression of cyclin D1 or the presence of t(11:14) within 12 months of study entry
Relapsed or refractory disease
At least one (>= 1) line of prior systemic therapy: - Inclusion of BTK inhibitor Prior therapy must have included a BTK inhibitor plus another systemic therapy option (e.g., a regimen containing a CD20 monoclonal antibody, prior chemotherapy, targeted agent therapy such as bortezomib, etc.) Progression or Relapse: Participants must have progressed or relapsed at any time on BTK inhibitor therapy, or failed to achieve a partial response (PR) within 12 weeks of BTK inhibitor therapy Exclusion of BTK Inhibitor Intolerance: Participants intolerant to BTK inhibitor therapy who are unable to complete at least 12 weeks of BTK inhibitor therapy should be excluded Local Therapies: Local therapies (e.g., radiotherapy) will not be considered as lines of therapy
Adequate renal function, defined as an estimated creatinine clearance 30 mL/min
Adequate hematologic function
CRITERIOS DE EXCLUSIÓN
History of other malignancy that could affect compliance with the protocol or interpretation of results - Patients with a prior or concurrent malignancy whose natural history or treatment does not have the potential to interfere with the compliance of or safety or efficacy assessment of the investigational regimen are eligible for this study
Leukemic, non-nodal MCL
Prior solid organ transplantation, prior allogeneic stem cell transplant
Prior treatment with glofitamab or other bispecific antibodies targeting both CD20 and CD3 and also treatment with chimeric antigen receptor T-cell (CAR-T) cell therapy
Primary or secondary central nervous system (CNS) lymphoma at the time of recruitment or history of CNS lymphoma
Presence of severe active bacterial, viral, fungal, mycobacterial, parasitic, or other infections at the time of study enrolment. Participants must have recovered from any severe or potentially serious infection (as assessed by the investigator) at least 2 weeks before the first study treatment
Clinically significant history of cirrhotic liver disease
Leukemic, non-nodal MCL
Prior solid organ transplantation, prior allogeneic stem cell transplant
Prior treatment with glofitamab or other bispecific antibodies targeting both CD20 and CD3 and also treatment with chimeric antigen receptor T-cell (CAR-T) cell therapy
Primary or secondary central nervous system (CNS) lymphoma at the time of recruitment or history of CNS lymphoma
Presence of severe active bacterial, viral, fungal, mycobacterial, parasitic, or other infections at the time of study enrolment. Participants must have recovered from any severe or potentially serious infection (as assessed by the investigator) at least 2 weeks before the first study treatment
Clinically significant history of cirrhotic liver disease
DESCRIPCIÓN
To evaluate the efficacy of glofitamab monotherapy compared with an investigators choice of bendamustine with rituximab (BR) or lenalidomide with rituximab (R-Len) with respect to progression-free survival (PFS)
PALABRAS CLAVE
antagonistas de la vitamin k, blastic plasmacytoid dendritic cell neoplasm (bpdcn), cord blood, donor lymphocyte infusion, emr, factor xi, fit aml, hematopoietic stem cell transplant, langerhans cell histiocytosis, leucemia linfocítica crónica (llc / cll), lma fit, lymphoma, mantle cell lymphoma, non-langerhans cell histiocytosis, ph + acute lymphoblastic leukemia, sickle cell disease, stem cell, umbilical cord blood, vitamin k antagonist
