Skip to content

Primary treatment of follicular lymphoma with rituximab-lenalidomide-tafasitamab for high-risk disease and rituximab-lenalidomide with a 1:1 randomization to tafasitamab for low-risk disease: a phase II study – NLG-FL7

Status
Recruiting
Phases
Phase 2
Study type
Interventional
Source
EU CTIS
Registry ID
CTIS2023-508196-36-00
Enrollment
270
Registered
2025-02-26
Start date
2025-05-27
Completion date
Unknown
Last updated
2025-04-28

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

Conditions

Follicular lymphoma

Brief summary

EFS24, defined as the interval between treatment start and progression or new lymphoma treatment or death, whichever occurs first, within 2 years of study entry.

Detailed description

EFS, defined as the interval between treatment start and progression or new lymphoma treatment or death, whichever occurs first., PFS, defined as the interval between treatment start and progression or death, whichever occurs first., POD24, defined as the interval between treatment start and progression or death, whichever occurs first, within 2 years of study entry., OS, defined as the interval between treatment start and death., ORR, defined as the sum of the rates of CR or PR at best response., CRR, defined as the sum of the rates of CR at best response., LSS, defined as the interval between treatment start and death of lymphoma (other causes are censored at the date of death)., Time to next treatment, defined as the interval between treatment start and that of documented new anti-lymphoma therapy., Duration of response, defined as the interval between when criteria for response (CR or PR) are met to the first documentation of progression., Incidence of transformation. Cases of transformation are documented with respect to transformation type and date., Safety based on the incidence and severity of AEs. Frequency and duration of all grade 3-5 treatment-related adverse events (AEs) according to CTCAE 5.0., HR-QoL as measured by EORTC QLQ-C30

Interventions

Sponsors

Karolinska University Hospital
Lead SponsorOTHER

Eligibility

Sex/Gender
All
Age
18 Years to No maximum

Design outcomes

Primary

MeasureTime frame
EFS24, defined as the interval between treatment start and progression or new lymphoma treatment or death, whichever occurs first, within 2 years of study entry.

Secondary

MeasureTime frame
EFS, defined as the interval between treatment start and progression or new lymphoma treatment or death, whichever occurs first., PFS, defined as the interval between treatment start and progression or death, whichever occurs first., POD24, defined as the interval between treatment start and progression or death, whichever occurs first, within 2 years of study entry., OS, defined as the interval between treatment start and death., ORR, defined as the sum of the rates of CR or PR at best response., CRR, defined as the sum of the rates of CR at best response., LSS, defined as the interval between treatment start and death of lymphoma (other causes are censored at the date of death)., Time to next treatment, defined as the interval between treatment start and that of documented new anti-lymphoma therapy., Duration of response, defined as the interval between when criteria for response (CR or PR) are met to the first documentation of progression., Incidence of transformation. Cases of tran

Countries

Denmark, Finland, Iceland, Norway, Sweden

Outcome results

None listed

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