Diffuse large B-cell lymphomas (DLBCL, Diffuse large B-cell lymphoma) and aggressive B-cell lymphomas (HGBCL, High-grade B-cell lymphoma) originate from mature B-cells at various stages of terminal differentiation
Conditions
Brief summary
ORR for second-line treatment initiated based on a diagnostic algorithm that takes into account cfDNA levels., The incidence of grade 3 and 4 adverse reactions assessed according to CTCAE v. 5.
Detailed description
Assessment of health-related quality of life using the EORTC QLQ-C30 generic questionnaire., Sensitivity, specificity, PPV, NPV of circulating DNA assay measured by NGS and/or ddPCR (individually selected markers) after first-line treatment in relation to the likelihood of maintaining CR status at 36 months of follow-up, TTNT since the end of first-line treatment, which will be referenced to archival/historical groups of patients treated at hematology centers collaborating in the PLRG
Interventions
DRUGRevlimid 10 mg hard capsules
DRUGBendamustine Glenmark
DRUG2
DRUG5 mg/ml
DRUGproszek do sporządzania koncentratu roztworu do infuzji
DRUGRevlimid 7.5 mg hard capsules
DRUGRevlimid 15 mg hard capsules
DRUGRevlimid 25 mg hard capsules
DRUGALEXAN
DRUG20 MG/ML
DRUGRevlimid 5 mg hard capsules
DRUG50 MG/ML
DRUGRiximyo 100 mg concentrate for solution for infusion
DRUGCisplatin Ebewe 1 mg/ml infuusiokonsentraatti
DRUGliuosta varten
DRUG40 mg
DRUGtabletki
DRUG20 mg
Sponsors
Instytut Hematologii I Transfuzjologii
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| ORR for second-line treatment initiated based on a diagnostic algorithm that takes into account cfDNA levels., The incidence of grade 3 and 4 adverse reactions assessed according to CTCAE v. 5. | — |
Secondary
| Measure | Time frame |
|---|---|
| Assessment of health-related quality of life using the EORTC QLQ-C30 generic questionnaire., Sensitivity, specificity, PPV, NPV of circulating DNA assay measured by NGS and/or ddPCR (individually selected markers) after first-line treatment in relation to the likelihood of maintaining CR status at 36 months of follow-up, TTNT since the end of first-line treatment, which will be referenced to archival/historical groups of patients treated at hematology centers collaborating in the PLRG | — |
Countries
Poland
Outcome results
None listed