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

N

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)

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

Trial contacts and locations

1

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Central trial contact

Liren Qian, M.D.

Data sourced from clinicaltrials.gov

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