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

NCT03569995 · Status: UNKNOWN · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 35

Last updated 2020-10-22

No results posted yet for this study

Summary

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.

Conditions

  • Primary CNS Lymphoma

Interventions

DRUG

Rituximab

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)

DRUG

Methotrexate

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

DRUG

Cytarabine Injection

3000 mg/m2 + 5%DW 200 mL IVF over 2 hrs steroid eye drop 0.1%, 2 drops q 6hrs, on days 1-9

Sponsors & Collaborators

  • Celltrion

    collaborator INDUSTRY

  • Won Seog Kim

    lead OTHER

Principal Investigators

  • Wonseog Kim, M.D · Samsung Medical Center

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
60 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2018-11-30
Primary Completion
2024-06-30
Completion
2025-06-30

Countries

  • South Korea

Study Locations

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Entities

Drugs
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03569995 on ClinicalTrials.gov