Clinical trial · Interventional
Study on Tailored Treatment in Elderly Patients With Newly Diagnosed Primary Lymphoma of Central Nervous System
Randomized Phase II Trial on Fitness- and Comorbidity- Tailored Treatment in Elderly Patients With Newly Diagnosed Primary CNS Lymphoma (FIORELLA Trial)
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
Primary central nervous system lymphomas are rare aggressive malignancies, usually treated in two steps: an induction phase (where a combination of chemotherapy is given) followed by a consolidation phase (where patients usually receive one of the following: whole-brain irradiation, chemotherapy supported by autologous stem-cell transplantation, other type of chemotherapy, or are just observed). The feasibility of this overall strategy, for several reasons, is limited in elderly patients . This study involves patients aged ≥70 years. The more fit patients will receive the standard chemotherapy combination (high-dose methotrexate, procarbazine and rituximab) as induction. Responding patients will receive either procarbazine or lenalidomide as maintenance therapy; the aim is to evaluate the efficacy of these two drugs. The more fragile patients will receive a less aggressive therapy consisting of concomitant whole-brain radiotherapy, temozolomide and rituximab as induction therapy, followed by temozolomide as maintenance treatment; the aim is to evaluate the efficacy of this combination of treatment.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Primary Central Nervous System Lymphoma | Primary Central Nervous System Lymphoma | ONTOLOGY_EXACT | 0.98 |
Interventions
Interventions (6)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Lenalidomide | Drug | Lenalidomide | ALIAS |
| Methotrexate | Drug | Methotrexate | ALIAS |
| Procarbazine | Drug | Procarbazine | ALIAS |
| Radiotherapy | Radiation | — | UNRESOLVED |
| Rituximab | Drug | Rituximab | ALIAS |
| Temozolomide | Drug | Temozolomide | ALIAS |
Design
Arms and outcomes
Arms (3)
- type
- EXPERIMENTAL
- label
- Lenalidomide (experimental arm of part A)
- description
- Patients in part A will receive 2 courses of induction chemo-immunotherapy: Rituximab 375 mg/m2 i.v. on days -6, 1, 15, 29; Methotrexate 3 g/m2 0.5 g/m2 in 15 min. +2.5 g/m2 in 3-hr inf. on days 2,16,30; Procarbazine 60 mg/m2/d oral on days 2 to 11. The duration of each treatment course is 43 days. Patients will then be randomized to receive lenalidomide or procarbazine as maintenance therapy. Lenalidomide is given 25 mg/d per os, days 1 to 21 every 4 weeks for 24 courses
- interventionNames
- Drug: Rituximab
- Drug: Methotrexate
- Drug: Procarbazine
- Drug: Lenalidomide
- type
- ACTIVE_COMPARATOR
- label
- Procarbazine (comparator arm of part A)
- description
- Patients in part A will receive 2 courses of induction chemo-immunotherapy: Rituximab 375 mg/m2 i.v. on days -6, 1, 15, 29; Methotrexate 3 g/m2 0.5 g/m2 in 15 min. +2.5 g/m2 in 3-hr inf. on days 2,16,30; Procarbazine 60 mg/m2/d oral on days 2 to 11. The duration of each treatment course is 43 days. Patients will then be randomized to receive lenalidomide or procarbazine as maintenance therapy. Procarbazine is given 100 mg/d per os, days 1 to 5 every 4 weeks for 6 courses
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 70 Years
Show eligibility criteria text
Inclusion Criteria: * Histologically or cytologically assessed diagnosis of CD20+ diffuse large B-cell lymphoma. * Diagnostic sample obtained by stereotactic or surgical biopsy, CSF cytology examination or vitrectomy. * Lymphoma exclusively localized in the central nervous system (brain parenchyma and/or meningeal/CSF dissemination and/or eyes and/or cranial nerves). * Previously untreated patients (previous or ongoing steroid therapy admitted). * Age ≥70 years * Patients not eligible for high-dose chemotherapy supported by autologous stem cell transplant * ECOG PS ≤3. * Adequate bone marrow, cardiac, renal, and hepatic function * No previous or concurrent malignancies with the exception of surgically cured carcinoma in-situ of the cervix, carcinoma of the skin or other cancers without evidence of disease at least for 3 years (patients with a previous lymphoma at any time are NOT eligible). * Absence of any familial, sociological or geographical condition potentially hampering compliance with the study protocol and follow-up schedule. * No concurrent treatment with other experimental drugs. * Patients receiving oral lenalidomide or procarbazine must agree to avoid sharing the study medication with another person and to return all unused study drug to the investigator. * Male patients must agree to always use a latex or synthetic condom during any sexual contact with females of reproductive potential while taking lenalidomide, during dose interruptions and for up to 7 days after treatment discontinuation, even if they have undergone a successful vasectomy. * Informed consent from the patient, or legal representative, obtained before registration. Exclusion Criteria: * Lymphoma entity other than diffuse large B-cell lymphoma. * Extra-CNS disease. * Lymphoma exclusively localized in the eyes * Lymphoma infiltration of the cranial nerves as exclusive site of disease * Previous antineoplastic treatment for the PCNSL. * Patients eligible for ASCT. * HBsAg- and HCV-positive patients; HBsAg- and HCV-positive patients. HBcAb+ is not exclusion criteria in the absence of detectable levels HBVDNA. * HIV disease or immunodeficiency. * Severe concomitant illnesses/medical conditions (e.g. impaired respiratory and/or cardiac function, uncontrolled diabetes mellitus despite optimal medical management). * Active infectious disease. * Hypersensitivity to any active principle and/or any excipient according to the contraindications reported in the Summary of Product Characteristics (SmPCs) of the anticancer drugs used in the study
References
Publications (0)
Data not yet available