Follicular lymphoma
Conditions
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
Eligibility
Design outcomes
Primary
| Measure | Time 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
| Measure | Time 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