Back to resultsTreatment of PCNSL With R-IDARAM and Intrathecal Immunochemotherapy
Primary Purpose
Primary Central Nervous System Lymphoma
Status
Recruiting
Phase
Phase 2
Locations
China
Study Type
Interventional
Intervention
R-IDARAM plus intrathecal chemotherapy
Sponsored by
About this trial
This is an interventional treatment trial for Primary Central Nervous System Lymphoma
Eligibility 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.
Sites / Locations
- Navy General HospitalRecruiting
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
R-IDARAM plus intrathecal chemotherapy
Arm Description
Patients will be treated with systemic R-IDARAM plus intrathecal immunochemotherapy
Outcomes
Primary Outcome Measures
Overall survival
3 year Overall survival
Secondary Outcome Measures
Full Information
NCT ID
NCT02657785
First Posted
April 23, 2014
Last Updated
September 8, 2020
Sponsor
Navy General Hospital, Beijing
1. Study Identification
Unique Protocol Identification Number
NCT02657785
Brief Title
Treatment of PCNSL With R-IDARAM and Intrathecal Immunochemotherapy
Official Title
Treatment of Primary CNS Lymphoma With Systemic R-IDARAM Chemotherapy and Intrathecal Immunochemotherapy
Study Type
Interventional
2. Study Status
Record Verification Date
September 2020
Overall Recruitment Status
Recruiting
Study Start Date
September 2010 (undefined)
Primary Completion Date
December 2028 (Anticipated)
Study Completion Date
December 2030 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Navy General Hospital, Beijing
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Primary Central Nervous System Lymphoma
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2, Phase 3
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
100 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
R-IDARAM plus intrathecal chemotherapy
Arm Type
Experimental
Arm Description
Patients will be treated with systemic R-IDARAM plus intrathecal immunochemotherapy
Intervention Type
Drug
Intervention Name(s)
R-IDARAM plus intrathecal chemotherapy
Other Intervention Name(s)
R-IDARAM plus intrathecal immuochemotherapy
Intervention Description
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.
Primary Outcome Measure Information:
Title
Overall survival
Description
3 year Overall survival
Time Frame
3 year Overall survival
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility 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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Liren Qian, M.D.
Phone
+861066957676
Email
qlr2007@126.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Liren Qian, M.D.
Organizational Affiliation
Navy General Hospital, Beijing
Official's Role
Study Chair
Facility Information:
Facility Name
Navy General Hospital
City
Beijing
State/Province
Beijing
ZIP/Postal Code
100048
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Liren Qian, M.D.
Phone
+861066957676
Email
qlr2007@126.com
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Treatment of PCNSL With R-IDARAM and Intrathecal Immunochemotherapy
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