In the present trial the chemotherapy- light treatment concept R-Pola-Glo will be evaluated that combines the anti-CD20 antibody rituximab (R) with the ADC polatuzumab vedotin (Pola) and the (BiMabs) glofitamab (Glo) in elderly and/or medical unfit and previously untreated patients with aggressive B-cell lymphoma. The outcome and feasibility data obtained here will be used for further clinical development of this new chemolight triple combination.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
125
Glofitamab is a fully humanized, engineered monoclonal bivalent antibody of the IgG1 isotype.
Rituximab is a genetically engineered chimeric mouse/human anti-CD20 monoclonal antibody
Obinutuzumab is a fully humanized, glycoengineered type II monoclonal antibody of the IgG1 isotype that binds to an epitope on CD20
Polatuzumab vedotin is an antibody-drug-conjugate that contains a humanized IgG1 anti-CD79b monoclonal antibody (MCDS4409A) and a potent anti-mitotic agent (MMAE) linked through a protease-cleavable linker.
Uniklinik Innsbruck
Innsbruck, Austria
Kepler Universitätsklinikum
Linz, Austria
Ordensklinikum Linz - Barmherzige Schwestern
Linz, Austria
Ordensklinikum Linz - Elisabethinen
Linz, Austria
Landeskrankenhaus Salzburg Universitätsklinikum der Paracelsus Medizinischen Privatuniversität
Salzburg, Austria
Univ. Klinikum St. Pölten
Sankt Pölten, Austria
AKH Meduni Wien
Vienna, Austria
Hanusch Krankenhaus
Vienna, Austria
Universitätsklinikum Magdeburg
Magdeburg, Saxony-Anhalt, Germany
Charité - Universitätsmedizin Berlin
Berlin, Germany
...and 18 more locations
1 year progression-free survival (PFS) rate of the first 80 patients
defined as the time from the day of inclusion until disease progression (PD) or relapse after complete remission (CR), or death due to any cause, whichever occurs first
Time frame: 12 months
Event-free survival (EFS)
defined as the time from the day of inclusion until progressive disease or relapse after complete remission, initiation of subsequent systemic antilymphoma treatment, radiation of single PET-CT positive lesions or death due to any cause, whichever occurs first.
Time frame: 54 months
Overall survival (OS)
defined as the time from the day of inclusion until death due to any cause
Time frame: 54 months
Response rate at different timepoints
Response rates after 2 cycles (during target dose phase), 6 cycles (end of target dose phase before start of consolidation phase) and 12 cycles (end of treatment following completion of consolidation phase). i.e., complete remission (CR) rate, partial remission (PR) rate, overall remission rate (ORR: CR+PR), stable disease (SD) rate and progressive disease (PD) rate
Time frame: 6 weeks, 18 weeks, 36 weeks
Relapse rate
defined as the number of patients with relapse, divided by the number of patients achieving C
Time frame: 54 months
Conversion rate of PR to CR
defined as the number of patients achieving mCR at the end of study treatment (including consolidation phase) divided by the number of patients achieving PR after end of target dose phase (before start of consolidation phase)
Time frame: 54 months
Duration of response (DoR)
defined as the time from documentation of CR until relapse or lymphoma associated death without documented relapse
Time frame: 54 months
Rate and type of adverse events (AEs) and serious adverse events (SAEs)
Time frame: 54 months
Rate of secondary malignancies
defined as the number of patients with secondary malignancies divided by the number of analyzable patients
Time frame: 54 months
Treatment-related death rate
defined as the number of treatment related deaths during therapy or up to 2 months after the end of study treatment, but before the start of further treatment, divided by the number of analyzable patients
Time frame: 54 months
Protocol adherence
number and duration of R-Pola-Glo cycles, number and duration of glofitamab maintenance, cumulative and relative doses of rituximab, glofitamab and polatuzumab.
Time frame: 54 months
Patient-reported outcomes for quality of life (QoL): EORTC QLQ-C30
measured by EORTC QLQ-C30 (a 30-item questionnaire developed by the European Organisation for Research and Treatment of Cancer). All of the scales and single-item measures range in score from 0 to 100. A high scale score represents a higher response level.
Time frame: 54 months
Patient-reported outcomes for quality of life (QoL): FACT-Lym
measured by FACT-Lym (Functional Assessment of Cancer Therapy - Lymphoma; scores from 0 - 4; The higher the score, the better the QOL)
Time frame: 54 months
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