Ireland
--:--IST
Latest
Astellas Expands Its 330 Million Euro Tralee Biopharma Facility with a Second Aseptic Filling Line to Double Drug-Product Capacity Xeolas Pharmaceuticals Opens 158,000 Sq Ft State-of-the-Art Baldoyle Facility to Scale Specialty Medicine Manufacturing Priya Life Science Partners with Fleming for the 9th Annual Corporate Compliance & Transparency in Life Sciences Summit in Zurich Ireland Has the Capital and the Lessons: Digital Project Management Is How They Become Delivery Dunbar Pharma Brings First Plant-Derived Dronabinol API to UK Market Through IPS Pharma Leveraging Priya Life Science as a Data Tracker: The Ultimate Use Case & Career Guide Astellas Expands Its 330 Million Euro Tralee Biopharma Facility with a Second Aseptic Filling Line to Double Drug-Product Capacity Xeolas Pharmaceuticals Opens 158,000 Sq Ft State-of-the-Art Baldoyle Facility to Scale Specialty Medicine Manufacturing Priya Life Science Partners with Fleming for the 9th Annual Corporate Compliance & Transparency in Life Sciences Summit in Zurich Ireland Has the Capital and the Lessons: Digital Project Management Is How They Become Delivery Dunbar Pharma Brings First Plant-Derived Dronabinol API to UK Market Through IPS Pharma Leveraging Priya Life Science as a Data Tracker: The Ultimate Use Case & Career Guide
Clinical Trials in China / NCT02657785
Recruiting Phase 2/3

Treatment of PCNSL With R-IDARAM and Intrathecal Immunochemotherapy

NCT02657785 · tracked via the Priya Life Science China tracker
Sponsor
Navy General Hospital, Beijing
Phase
Phase 2/3
Started
2010-09
Last updated
2020-09-09

Condition(s) studied

Primary Central Nervous System Lymphoma

Investigational drug(s) / intervention(s)

R-IDARAM plus intrathecal chemotherapy →

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.

Study summary

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

Eligibility

Sex
ALL
Min age
18 Years
Max age
75 Years
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.

Primary outcome measure(s)

  • Overall survival — 3 year Overall survival
    3 year Overall survival

Trial sites (1)

FacilityCityRegionStatus
Navy General Hospital Beijing Beijing Municipality Recruiting

More Navy General Hospital, Beijing trials in China

VA Conditioning Regimen Allo-HSCT for Elderly Higher-risk MDS Recruiting
Smart Technology Facilitated Patient-centered Venous Thromboembolism Management Starting soon
Smart Technology Facilitated Patient-centered Venous Thromboembolism Management Enrolling by invitation
Effect of Aerobic Interval Training on Atrial Fibrillation Burden Starting soon
Azacytidine Plus CAOLD Regimen in Relapsed/Refractory Peripheral T-Cell Lymphomas Recruiting

Other trials for the same condition

Rituximab-Methotrexate-Temozolomide-Thiotepa (RMTT) Regimen As First-line Therapy for PCNS DLBCL Recruiting
A Study of GNC-038, a Tetra-specific Antibody, in Patients With Central Nervous System Lymphoma (PCNSL) and Relapsed or Refractory Secondary Central Nervous System Lymphoma (SCNSL) Active, not recruiting
A Multicenter, Prospective Clinical Trial With a Concurrent Control Evaluating Methotrexate Combined With Rituximab,Sintilimab and Pirtobrutinib vs. Investigator-Selected Standard of Care in Treatment-Naive PCNSL Recruiting
R-MA-PD-1 Versus R-MA in Treatment-naive Primary CNS Lymphoma Starting soon
Orelabrutinib,Rituximab and Methotrexate in Newly Diagnosed Primary Central Nervous System Lymphoma Recruiting
Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT02657785 on ClinicalTrials.gov ↗ ← All trials in China