- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02836158
Therapeutic Effects of R-IDARAM and Intrathecal Immunochemotherapy on Elderly Patients With PCNSL
September 8, 2020 updated by: Liren Qian, Navy General Hospital, Beijing
Therapeutic Effects of R-IDARAM and Intrathecal Immunochemotherapy on Elderly Patients With Primary CNS Lymphoma
This study suggests that R-IDARAM combined with intrathecal immunochemotherapy may be high effective in elderly patients with primary central nervous system lymphoma (PCNSL).
Study Overview
Status
Recruiting
Conditions
Intervention / Treatment
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.
Study Type
Interventional
Enrollment (Anticipated)
100
Phase
- Phase 2
- Phase 3
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact
- Name: Liren Qian, M.D.
- Phone Number: +861066957676
- Email: qlr2007@126.com
Study Locations
-
-
Beijing
-
Beijing, Beijing, China, 100048
- Recruiting
- Navy General Hospital
-
Contact:
- Liren Qian, M.D.
- Phone Number: +861066957676
- Email: qlr2007@126.com
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
60 years to 75 years (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
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.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: R-IDARAM plus intrathecal chemotherapy
Patients will be treated with systemic R-IDARAM plus intrathecal immunochemotherapy
|
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 Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Overall survival
Time Frame: 3 year Overall survival
|
3 year Overall survival
|
3 year Overall survival
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Study Chair: Liren Qian, M.D., Navy General Hospital, Beijing
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
September 1, 2010
Primary Completion (Anticipated)
December 1, 2025
Study Completion (Anticipated)
December 1, 2030
Study Registration Dates
First Submitted
July 14, 2016
First Submitted That Met QC Criteria
July 14, 2016
First Posted (Estimate)
July 18, 2016
Study Record Updates
Last Update Posted (Actual)
September 9, 2020
Last Update Submitted That Met QC Criteria
September 8, 2020
Last Verified
September 1, 2020
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- NavyGHB-002
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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