Treatment on CNS lymphoma in elderly patients

Randomized phase II trial of fitness- and comorbidity- tailored treatment in elderly patientys with newly doagnosed primary CNS lymphoma - Fiorella trial

Status

Active, not recruiting

Phases

Phase 2

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2016-003116-12-FI

Enrollment

199

Registered

2019-04-01

Start date

2019-05-03

Completion date

Unknown

Last updated

2025-01-27

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

Conditions

Primary central nervous system lymphoma

Interventions

Product Name: methotrexate Pharmaceutical Form: Infusion Product Name: temozolomide Pharmaceutical Form: Capsule

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 1) Cd20+ DLBCL of brain 2) Lymphoma localized in CNS system only 3) Previously untreated patients 4)Age over 70 5) The patient is not transplant eligible 6)ECOG three or less 7) No other serious comorbidities and adequate organ function 8) Written informed consent Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) no F.1.2.1 Number of subjects for this age range F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 199

Exclusion criteria

Exclusion criteria: 1) Lymphoma other than DLBCL 2) Extra CNS disease 3) Eye involvement only 4) Previous therapy for PCNSL 5) Transplant eligible patient 6) Persisten infections or other serious concomitant infections

Design outcomes

Primary

Measure	Time frame
Main Objective: Arm A: To compare the efficacy and safety of two different maintenance therapies in the treatment of elderly patients with PCNSL Arm B: To study the efficacy and safety of concomitant chemoimmunoradiotherapy in old and fragile patients with PCNSL;Secondary Objective: Not applicable;Primary end point(s): 2year progression free survival;Timepoint(s) of evaluation of this end point: 2 year	—

Measure

Time frame

Main Objective: Arm A: To compare the efficacy and safety of two different maintenance therapies in the treatment of elderly patients with PCNSL Arm B: To study the efficacy and safety of concomitant chemoimmunoradiotherapy in old and fragile patients with PCNSL;Secondary Objective: Not applicable;Primary end point(s): 2year progression free survival;Timepoint(s) of evaluation of this end point: 2 year

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Secondary

Measure	Time frame
Secondary end point(s): Arm A: Duration of response, relapse rate and pattern, overall survival, toxicity, especially neurotoxicity, difference of these parametres between two treatment arms ArmB: Response rate, duration of response, relapse rate and pattern, overall survival, toxicity, especially neurotoxicity, ;Timepoint(s) of evaluation of this end point: Acute toxicities are monitored during the treatment. Efficacfy is evaluated druing response evaluations and follow-up visit.	—

Measure

Time frame

Secondary end point(s): Arm A: Duration of response, relapse rate and pattern, overall survival, toxicity, especially neurotoxicity, difference of these parametres between two treatment arms ArmB: Response rate, duration of response, relapse rate and pattern, overall survival, toxicity, especially neurotoxicity, ;Timepoint(s) of evaluation of this end point: Acute toxicities are monitored during the treatment. Efficacfy is evaluated druing response evaluations and follow-up visit.

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Countries

Denmark, Finland, Italy, Switzerland

Contacts

Public ContactIELSG headquarter

IELSG

elisabetta.gastaldi@eoch.ch++4191811 89549111

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026