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Treatment of PCNSL With R-IDARAM and Intrathecal Immunochemotherapy

This study is enrolling participants by invitation only.
Sponsor:
ClinicalTrials.gov Identifier:
NCT02657785
First Posted: January 18, 2016
Last Update Posted: September 27, 2016
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. Read our disclaimer for details.
Information provided by (Responsible Party):
Liren Qian, Navy General Hospital, Beijing
  Purpose
This study suggests that R-IDARAM combined with intrathecal immunochemotherapy may be high effective in primary central nervous system lymphoma (PCNSL) patients.

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

Study Type: Interventional
Study Design: 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

Resource links provided by NLM:


Further study details as provided by Liren Qian, Navy General Hospital, Beijing:

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

Estimated Enrollment: 100
Study Start Date: September 2010
Estimated Study Completion Date: December 2024
Estimated Primary Completion Date: December 2018 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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.
  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Senior)
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.
  Contacts and Locations
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): NCT02657785


Locations
China, Beijing
Navy General Hospital
Beijing, Beijing, China, 100048
Sponsors and Collaborators
Navy General Hospital, Beijing
Investigators
Study Chair: Liren Qian, M.D. Navy General Hospital
  More Information

Responsible Party: Liren Qian, Doctor, Navy General Hospital, Beijing
ClinicalTrials.gov Identifier: NCT02657785     History of Changes
Other Study ID Numbers: NavyGHB-001
001 ( Other Grant/Funding Number: NavyGHB )
First Submitted: April 23, 2014
First Posted: January 18, 2016
Last Update Posted: September 27, 2016
Last Verified: September 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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