[CREMA]Combination of R-M Followed by R-A in Elderly Patients With Primary CNS Lymphoma

Sponsor
Won Seog Kim
Study ID
NCT03569995
Phase
PHASE2
Status
Unknown

Conditions

  • Primary CNS Lymphoma

Eligibility Criteria

Sex
ALL
Age
60 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Rituximab — DRUG
    500 mg/m2 + 5%DW 500 mL IVF Begin with 50 mg/hr (increase by 50 mg/hr per 30 min until 400 mg/hr is reached)
  • Methotrexate — DRUG
    500 mg/m2 + 5%DW 200 mL IV over 15 minutes 3000 mg/m2 + 5%DW 500 mL IVF over 3 hrs Concurrent hydration and subsequent leucovorin rescue is mandatory
  • Cytarabine Injection — DRUG
    3000 mg/m2 + 5%DW 200 mL IVF over 2 hrs steroid eye drop 0.1%, 2 drops q 6hrs, on days 1-9

Study Details

This study was conducted to evaluate the 2-year progression free survival rate of elderly patients with primary CNS lymphoma followed by combination of rituximab and methotrexate followed by rituximab and cytarabine.

Key Dates

Start date
Nov 30, 2018
Status verified
Oct 2020
Primary completion
Jun 30, 2024
Completion
Jun 30, 2025

Study Design

Enrollment
35 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: Induction+Consolidation chemotherapy
    \[Induction phase\] ① After induction therapy (Rituximab-Methotrexate) 2 times, first evaluation * Complete, partial response or stable disease-\> next step * Progressive disease-\> eliminated ② After Induction therapy (Rituximab-Methotrexate) was added 3 times (total 5 times), 2nd evaluation * Complete response -\> consolidation therapy(Rituximab-Cytarabine) progress * Partial response or stable disease-\> Rituximab-Methotrexate 2 additional administrations * Progressive disease-\> eliminated ③ After Induction therapy (Rituximab-Methotrexate) was added twice (7 times in total), 3rd evaluation * Complete, partial response or stable disease-\> consolidation therapy(Rituximab-Cytarabine) * Progressive disease-\> eliminated

Primary Outcome Measure

2-year progression free survival rate [ Time Frame: the time between the date of treatment start and the date of death due to any cause or date of disease, assessed up to 24 months ]

Central Contacts