Study of Tailored Treatment in Elderly Patients with Newly Diagnosed Primary Central Nervous System Lymphoma (FIORELLA Trial)

Phase 1

• Conditions: Patients with newly diagnosed primary central nervous system lymphoma with age =70 years old; MedDRA version: 21.0Level: PTClassification code 10007953Term: Central nervous system lymphomaSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps); Therapeutic area: Diseases [C] - Cancer [C04]

• Registration Number: EUCTR2016-003116-12-DK
• Lead Sponsor: International Extranodal Lymphoma Study Group - IELSG

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2019-02-14
• Last Update Posted: 12 April 2021

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: All
• Target Recruitment: 208

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).
- No concurrent treatment with other experimental drugs.
- 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.
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 208

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

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified