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Treatment of PCNSL With R-IDARAM and Intrathecal Immunochemotherapy

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ClinicalTrials.gov Identifier: NCT02657785
Recruitment Status : Recruiting
First Posted : January 18, 2016
Last Update Posted : August 26, 2019
Sponsor:
Information provided by (Responsible Party):
Liren Qian, Navy General Hospital, Beijing

Tracking Information
First Submitted Date  ICMJE April 23, 2014
First Posted Date  ICMJE January 18, 2016
Last Update Posted Date August 26, 2019
Study Start Date  ICMJE September 2010
Estimated Primary Completion Date December 2028   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: August 22, 2019)
Overall survival [ Time Frame: 3 year Overall survival ]
3 year Overall survival
Original Primary Outcome Measures  ICMJE
 (submitted: January 15, 2016)
Overall survival [ Time Frame: 3 year Overall survival ]
Change History Complete list of historical versions of study NCT02657785 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Treatment of PCNSL With R-IDARAM and Intrathecal Immunochemotherapy
Official Title  ICMJE Treatment of Primary CNS Lymphoma With Systemic R-IDARAM Chemotherapy and Intrathecal Immunochemotherapy
Brief Summary This study suggests that R-IDARAM combined with intrathecal immunochemotherapy may be high effective in primary central nervous system lymphoma (PCNSL) patients.
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.
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Phase 3
Study Design  ICMJE Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Primary Central Nervous System Lymphoma
Intervention  ICMJE 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
Study Arms  ICMJE Experimental: R-IDARAM plus intrathecal chemotherapy
Patients will be treated with systemic R-IDARAM plus intrathecal immunochemotherapy
Intervention: Drug: R-IDARAM plus intrathecal chemotherapy
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: January 15, 2016)
100
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE December 2030
Estimated Primary Completion Date December 2028   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 75 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Liren Qian, M.D. +861066957676 qlr2007@126.com
Listed Location Countries  ICMJE China
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02657785
Other Study ID Numbers  ICMJE NavyGHB-001
001 ( Other Grant/Funding Number: NavyGHB )
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party Liren Qian, Navy General Hospital, Beijing
Study Sponsor  ICMJE Navy General Hospital, Beijing
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Chair: Liren Qian, M.D. Navy General Hospital
PRS Account Navy General Hospital, Beijing
Verification Date August 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP