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Trial record 9 of 15 for:    "Central Nervous System Lymphoma" | "Dexamethasone"

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

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ClinicalTrials.gov Identifier: NCT02836158
Recruitment Status : Recruiting
First Posted : July 18, 2016
Last Update Posted : May 24, 2019
Sponsor:
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 elderly patients with primary central nervous system lymphoma (PCNSL).

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 elderly patients with 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: Therapeutic Effects of R-IDARAM and Intrathecal Immunochemotherapy on Elderly Patients With Primary CNS Lymphoma
Study Start Date : September 2010
Estimated Primary Completion Date : December 2025
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); 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 Name: R-IDARAM plus intrathecal immuochemotherapy




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


Information from the National Library of Medicine

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Ages Eligible for Study:   60 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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 ClinicalTrials.gov identifier (NCT number): NCT02836158


Contacts
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Contact: Liren Qian, M.D. +861066957676 qlr2007@126.com

Locations
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China, Beijing
Navy General Hospital Recruiting
Beijing, Beijing, China, 100048
Contact: Liren Qian, M.D.    +861066957676    qlr2007@126.com   
Sponsors and Collaborators
Navy General Hospital, Beijing
Investigators
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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
ClinicalTrials.gov Identifier: NCT02836158     History of Changes
Other Study ID Numbers: NavyGHB-002
First Posted: July 18, 2016    Key Record Dates
Last Update Posted: May 24, 2019
Last Verified: May 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

Additional relevant MeSH terms:
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Lymphoma
Neoplasms by Histologic Type
Neoplasms
Lymphoproliferative Disorders
Lymphatic Diseases
Immunoproliferative Disorders
Immune System Diseases