Therapeutic Effects of R-IDARAM and Intrathecal Immunochemotherapy on Elderly Patients With PCNSL

Navy General Hospital, Beijing

Status and phase: Enrolling; Phase 3; Phase 2

Conditions: Primary Central Nervous System Lymphoma

Treatments: Drug: R-IDARAM plus intrathecal chemotherapy

Study type: Interventional

Funder types: Other

Identifiers

NCT02836158

NavyGHB-002

Details and patient eligibility

About

This study suggests that R-IDARAM combined with intrathecal immunochemotherapy may be high effective in elderly patients with primary central nervous system lymphoma (PCNSL).

Full description

The investigators will evaluate response rate, progression free survival (PFS), overall survival (OS), and toxicity in elderly patients with primary central nervous system lymphoma (PCNSL) after systemic and intrathecal immunochemotherapy with deferred radiotherapy.

Enrollment: 100 estimated patients

Sex: All

Ages: 60 to 75 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Newly diagnosed histologically proven non-Hodgkin's lymphoma (NHL).

Exclusion criteria

• Involved sites other than the brain, meninges, CSF, or the eyes.
• Age less than 18 years or greater than 75 years.
• Inadequate bone marrow capacity (defined as neutrophils<1.5 ×10^9/L, platelets <100 ×10^9/L, and hemoglobin level< 8 g/dL).
• Known cause of immunosuppression (ie, HIV type I infection).
• Any previous malignancy.
• Creatinine clearance below 60 mL/min.
• Heart insufficiency (NYHA IIIB or IV).
• Uncontrolled infection.
• Noncompensated active pulmonary or liver disease.
• Previously treated for PCNSL, except by corticosteroids.

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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100 participants in 1 patient group

R-IDARAM plus intrathecal chemotherapy

Experimental group

Description:

Patients will be treated with systemic R-IDARAM plus intrathecal immunochemotherapy

Treatment:

Drug: R-IDARAM plus intrathecal chemotherapy