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NCT Number: NCT02836158

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

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

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Key information

Conditions

Primary Central Nervous System Lymphoma

Age range

60 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2 / Phase 3

Primary location

Navy General Hospital

Beijing, Beijing Municipality, 100048, China

Location status: Recruiting

Location contact

Liren Qian, M.D.

CONTACT

[email protected]

+861066957676

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

R-IDARAM plus intrathecal chemotherapy

Drug

R-IDARAM comprised of rituximab 375 mg/m2 (day 1), idarubicin 10 mg/m2(day 2); dexamethasone 100 mg/m2 (12 h.infusion in day 2, 3 and 4); cytarabine 1 g/m2 (1 h. infusion in day 2); methotrexate 1.5 g/m2 (6 h. infusion in day 4 with folinic acid rescue). Intrathecal Immunochemotherapy comprised of rituximab 20mg, MTX 15mg, dexamethasone 5mg and Ara-c 50mg once a week.

Other names: R-IDARAM plus intrathecal immuochemotherapy

Primary outcomes

  1. Overall survival

    Time frame: 3 year Overall survival

    3 year Overall survival

Study contacts

Contact information is provided by the study sponsor or research team.

Liren Qian, M.D.

CONTACT

[email protected]

+861066957676

Sponsors and collaborators

Lead sponsor

Navy General Hospital, Beijing

Other

Registry information

Official study title

Therapeutic Effects of R-IDARAM and Intrathecal Immunochemotherapy on Elderly Patients With Primary CNS Lymphoma

Important dates

Study start
2010
Primary completion
2025
Study completion
2030
First posted
Jul 18, 2016
Registry last updated
Sep 9, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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