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A phase II efficacy and safety study of cell-free circulating tumor DNA-guided commencement of second-line treatment in patients with DLBCL/HGBCL relapse

Status
Not yet recruiting
Phases
Phase 2
Study type
Interventional
Source
EU CTIS
Registry ID
CTIS2024-518275-64-00
Acronym
IHIT/2021/1
Enrollment
340
Registered
2024-12-02
Start date
Unknown
Completion date
Unknown
Last updated
2025-11-24

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Diffuse large B-cell lymphoma) and aggressive B-cell lymphomas (HGBCL, Diffuse large B-cell lymphomas (DLBCL, High-grade B-cell lymphoma) originate from mature B-cells at various stages of terminal differentiation

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
DRUGRevlimid 20 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
DRUGYESCARTA 0.4 – 2 x 10e8 cells dispersion for infusion
DRUGRevlimid 2.5 mg hard capsules
DRUGPolivy 30 mg powder for concentrate for solution for infusion.
DRUGALEXAN
DRUG20 MG/ML
DRUGROZTWÓR DO WSTRZYKIWAŃ
DRUGRiximyo 500 mg concentrate for solution for infusion
DRUGRevlimid 5 mg hard capsules
DRUGMINJUVI 200 mg powder for concentrate for solution for infusion
DRUG50 MG/ML
DRUGROZTWÓR DO INFUZJI
DRUGRiximyo 100 mg concentrate for solution for infusion
DRUGCisplatin Ebewe 1 mg/ml infuusiokonsentraatti
DRUGliuosta varten
DRUGDexamethasone Krka
DRUG40 mg
DRUGtabletki
DRUGPolivy 140 mg powder for concentrate for solution for infusion.
DRUG20 mg

Sponsors

Instytut Hematologii I Transfuzjologii
Lead SponsorOTHER

Eligibility

Sex/Gender
All
Age
18 Years to No maximum

Design outcomes

Primary

MeasureTime 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

MeasureTime 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

Source: EU CTIS · Data processed: Feb 4, 2026