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Treatment of PCNSL With R-IDARAM and Intrathecal Immunochemotherapy

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details. Identifier: NCT02657785
Recruitment Status : Recruiting
First Posted : January 18, 2016
Last Update Posted : August 28, 2019
Information provided by (Responsible Party):
Liren Qian, Navy General Hospital, Beijing

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

Condition or disease Intervention/treatment Phase
Primary Central Nervous System Lymphoma Drug: R-IDARAM plus intrathecal chemotherapy Phase 2 Phase 3

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

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 100 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Treatment of Primary CNS Lymphoma With Systemic R-IDARAM Chemotherapy and Intrathecal Immunochemotherapy
Study Start Date : September 2010
Estimated Primary Completion Date : December 2028
Estimated Study Completion Date : December 2030

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Lymphoma

Arm Intervention/treatment
Experimental: R-IDARAM plus intrathecal chemotherapy
Patients will be treated with systemic R-IDARAM plus intrathecal immunochemotherapy
Drug: R-IDARAM plus intrathecal chemotherapy
R-IDARAM comprised of rituximab 375 mg/m2 (day 1), idarubicin 10 mg/m2(day 2 and 3); dexamethasone 100 mg/m2 (12 h.infusion in day 2, 3 and 4); cytarabine 1 g/m2 (1 h. infusion in day 2 and 3); methotrexate 2 g/m2 (6 h. infusion in day 4 with folinic acid rescue). Intrathecal Immunochemotherapy comprised of rituximab 10mg, MTX 15mg, dexamethasone 5mg and Ara-c 50mg once a week.
Other Name: R-IDARAM plus intrathecal immuochemotherapy

Primary Outcome Measures :
  1. Overall survival [ Time Frame: 3 year Overall survival ]
    3 year Overall survival

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT02657785

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Contact: Liren Qian, M.D. +861066957676

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China, Beijing
Navy General Hospital Recruiting
Beijing, Beijing, China, 100048
Contact: Liren Qian, M.D.    +861066957676   
Sponsors and Collaborators
Navy General Hospital, Beijing
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Study Chair: Liren Qian, M.D. Navy General Hospital

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Responsible Party: Liren Qian, Doctor, Navy General Hospital, Beijing Identifier: NCT02657785    
Other Study ID Numbers: NavyGHB-001
001 ( Other Grant/Funding Number: NavyGHB )
First Posted: January 18, 2016    Key Record Dates
Last Update Posted: August 28, 2019
Last Verified: August 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Additional relevant MeSH terms:
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Neoplasms by Histologic Type
Lymphoproliferative Disorders
Lymphatic Diseases
Immunoproliferative Disorders
Immune System Diseases