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CNS Prophylaxis in Diffuse Large B-cell Lymphoma

NCT02777736 · Status: UNKNOWN · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 500

Last updated 2016-06-06

No results posted yet for this study

Summary

Comparison of cumulative incidence of CNS relapses in patients with diffuse large B-cell lymphoma with intermediate or high risk of CNS relapse treated with CNS prophylaxis: either with 2 doses of intravenous methotrexate 3g/m2 i.v.(arm A) or 6 doses of intrathecal methotrexate 12mg (arm B) and in patients with low risk of CNS relapse without CNS prophylaxis (arm C).

Conditions

  • Diffuse Large B-cell Lymphoma

Interventions

DRUG

Methotrexate

i.v. or intrathecal CNS prophylaxis

Sponsors & Collaborators

  • Czech Lymphoma Study Group

    lead OTHER

Principal Investigators

  • Heidi Mocikova, M.D., Ph.D. · University Hospital Kralovske Vinohrady, Prague, Czech Republic

  • Marek Trněný, prof.M.D. · General University Hospital, Prague

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
72 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2015-07-31
Primary Completion
2018-12-31
Completion
2019-12-31

Countries

  • Czechia

Study Locations

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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 NCT02777736 on ClinicalTrials.gov