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NCT03123718
High-dose Intravenous Methotrexate Versus Intrathecal Methotrexate for Central Nervous System Prophylaxis in DLBCL
Phase 3 trial testing Intrathecal methotrexate in DLBCL in 205 participants. Status unknown.
30 June 2021
Quick facts
| Lead sponsor | Chonnam National University Hospital |
|---|---|
| Phase | Phase 3 |
| Status | Status unknown |
| Study type | INTERVENTIONAL |
| Allocation | randomized |
| Design | parallel |
| Masking | none |
| Primary purpose | prevention |
| Enrollment | 205 |
| Start date | 1 July 2017 |
| Primary completion | 30 June 2021 |
| Estimated completion | 30 June 2021 |
| Sites | 1 location across South Korea |
Drugs / interventions tested
- Intrathecal methotrexate — full drug profile →
- High-dose intravenous methotrexate — full drug profile →
Conditions studied
- DLBCL — all drugs for DLBCL →
Sponsor
Chonnam National University Hospital
Who can join
Adults 18 to 80, any sex, with DLBCL. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
The outcome of patients with central nervous system (CNS) relapse in DLBCL is poor, with median survival times of 2-5 months. This fatal prognosis necessitates CNS prevention in a subgroup of patients with a high risk of CNS relapse. Intrathecal methotrexate (ITMTX) has traditionally been used, although its efficacy for CNS prophylaxis is contradictory. High-dose intravenous methotrexate (IVMTX) has been suggested as an alternative approach. Considering the lack of evidence supporting the role of ITMTX, the investigators propose to compare the efficacy of ITMTX and IVMTX for prophylaxis of CNS relapse in a subgroup of patients with DLBCL at a high risk for CNS relapse.
Publications & conference data
1 peer-reviewed publication reference this trial (live from Europe PMC):
-
S229: PROPHYLACTIC EFFICACY OF INTRATHECAL VERSUS INTRAVENOUS METHOTREXATE FOR CNS RELAPSE IN HIGH-RISK DIFFUSE LARGE B CELL LYMPHOMA: A PHASE III RANDOMIZED, CONTROLLED STUDY
Yahng S, Yhim H, Kwak J, Shin H, et al · · 2023
Verify or expand the search:
- PubMed search for NCT03123718
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
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Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT03123718 (US National Library of Medicine, public domain)
- Publications: Europe PMC API search by NCT ID, retrieved 9 June 2026
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by Chonnam National University Hospital
- Last refreshed: 24 April 2017
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT03123718.
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