Treatment of PCNSL With R-IDARAM and Intrathecal Immunochemotherapy
NCT ID: NCT02657785
Last Updated: 2020-09-09
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
PHASE2/PHASE3
100 participants
INTERVENTIONAL
2010-09-30
2030-12-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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R-IDARAM plus intrathecal chemotherapy
Patients will be treated with systemic R-IDARAM plus intrathecal immunochemotherapy
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.
Interventions
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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 Intervention Names
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Eligibility Criteria
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Inclusion Criteria
Exclusion Criteria
* 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.
18 Years
75 Years
ALL
No
Sponsors
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Navy General Hospital, Beijing
OTHER
Responsible Party
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Liren Qian
Doctor
Principal Investigators
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Liren Qian, M.D.
Role: STUDY_CHAIR
Navy General Hospital, Beijing
Locations
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Navy General Hospital
Beijing, Beijing Municipality, China
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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001
Identifier Type: OTHER_GRANT
Identifier Source: secondary_id
NavyGHB-001
Identifier Type: -
Identifier Source: org_study_id
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