Rituximab in Combination With Glofitamab and Polatuzumab Vedotin in Patients With Previously Untr… (NCT05798156) | Clinical Trial Compass
Active — Not RecruitingPhase 2
Rituximab in Combination With Glofitamab and Polatuzumab Vedotin in Patients With Previously Untreated Aggressive B-cell Lymphoma Ineligible for R-CHOP
Austria125 participantsStarted 2023-03-20
Plain-language summary
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.
Who can participate
Age range61 Years
SexALL
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Inclusion criteria
✓. Patient has provided written informed consent and is able and willing to comply with the study protocol and protocol mandated treatments according to ICH and local regulations.
✓. Patient is above 60 years of age
✓. Patient is not eligible for a fully dosed R-CHOP
✓. Patient has histologically confirmed aggressive B-cell lymphoma.
✓. Patient has at least one measurable FDG PET-positive lymphoma manifestation; defined as lesional maximum FDG uptake higher than the maximum FDG uptake in unaffected liver parenchyma as measured in a reference volume-of-interest with \>10 mL
✓. Baseline biopsy material is available for central review.
✓. Female patients considered as women of childbearing potential (WOCBP, see section 5.2.7 for definition) and male patients with female partners considered as WOCBP must:
✓. agree to either remain completely abstinent (refrain from heterosexual intercourse) or to use at least one effective contraceptive methods that results in a failure rate of \< 1% per year
✕. Patient with known active infection, or reactivation of a latent infection, whether bacterial (e.g., tuberculosis), viral (including, but not limited to severe pneumonia, COVID-19, Epstein-Barr virus \[EBV\], cytomegalovirus \[CMV\], hepatitis B, hepatitis C, and HIV\], fungal, mycobacterial, or other pathogens (excluding fungal infections of nail beds) or any major episode of infection requiring hospitalization or treatment with IV antibiotics (for IV antibiotics this pertains to completion of last course of antibiotic treatment) within 4 weeks prior to study enrollment.
What they're measuring
1
1 year progression-free survival (PFS) rate of the first 80 patients
Timeframe: 12 months
Trial details
NCT IDNCT05798156
SponsorInstitut für Klinische Krebsforschung IKF GmbH at Krankenhaus Nordwest