High-Dose (HD) Methotrexate (MTX) Induction Chemotherapy Followed by Alternative HD MTX-based and HD Cytarabine-based Combination Consolidation Chemotherapy for Newly Diagnosed Primary CNS Lymphoma; CISL 10-01 Study

Phase 2

Completed

• Conditions: CNS Lymphoma

• Registration Number: NCT01083342
• Lead Sponsor: Samsung Medical Center

Brief Summary

The purpose of this study is to evaluate the complete response (CR) rate after HD-MTX induction chemotherapy followed by alternative HD MTX-based and HD Cytarabine-based combination consolidation chemotherapy

Detailed Description

Not available

Study Timeline

• Study Start: 2010-01
• Study First Submitted: 2010-03-08
• Study First Submitted QC: 2010-03-08
• Study First Posted: 2010-03-09
• Status Verified: 2012-05
• Primary Completion: 2012-05
• Study Completion: 2012-05
• Last Update Submitted: 2012-05-22
• Last Update Posted: 2012-05-24

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 36

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Primary Outcome Measures

Name	Time	Method
To evaluate the complete response (CR) after chemotherapy	24 months

Secondary Outcome Measures

Name	Time	Method
To evaluate the duration of response	24 months
To evaluate the progression-free survival, overall survival	24 months
To evaluate the safety profiles	24 months

Trial Locations

Locations (1)

Samsung Medical Center; 🇰🇷 Seoul, Korea, Republic of