Study on Tailored Treatment in Elderly Patients With Newly Diagnosed Primary Lymphoma of Central Nervous System

• Status: Recruiting
• Trial end date: 2023-10-31
• Target enrollment: 0
• Participant gender: All

Summary

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: International Extranodal Lymphoma Study Group (IELSG)
• Treatments: Dacarbazine; Lenalidomide; Methotrexate; Procarbazine; Rituximab; Temozolomide; Thalidomide

Criteria

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