Therapeutic Effects of R-IDARAM and Intrathecal Immunochemotherapy on Elderly Patients With PCNSL
Trial statusRecruiting
Trial phasePhase 2, Phase 3
Trial typeInterventional
Biological sexAll
Age60-75
SponsorNavy General Hospital, Beijing
About this trial
This study suggests that R-IDARAM combined with intrathecal immunochemotherapy may be high effective in elderly patients with primary central nervous system lymphoma (PCNSL).
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Newly diagnosed histologically proven non-Hodgkin's lymphoma (NHL).
Disqualifiers
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).
Trial design
Design model
Single group
Treatments tested in this trial
R-IDARAM plus intrathecal chemotherapy
DrugR-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.
Treatment groups
100 Participants
are divided into 1 treatment groupGroup A: R-IDARAM plus intrathecal chemotherapyExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
Overall survival
3 year Overall survival
Time frame
3 year Overall survivalSponsors and contacts
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Source ClinicalTrials.gov