Who is sponsoring NCT05135858?

NCT05135858 is sponsored by Assistance Publique - Hôpitaux de Paris.

What drugs are being tested in NCT05135858?

Interventions in NCT05135858: Glucarpidase, Methotrexate (MTX).

What condition does NCT05135858 study?

NCT05135858 studies Primary Central Nervous System Lymphoma.

Is NCT05135858 still recruiting?

NCT05135858 is currently status unknown. Last updated 25 October 2022.

Last reviewed 2022-10-25 · How we verify

NCT05135858: METHOGLU

Name: Drug Landscape Pharmaceutical Database
Creator: Drug Landscape
Published: 2026-01-01
License: https://creativecommons.org/licenses/by/4.0/

Dose Dense Re-challenge of High Dose Methotrexate With Glucarpidase for Relapsed Primary Central Nervous System Lymphoma

Status unknown Phase 1 Last updated 25 October 2022

What this trial tests

Phase 1 trial testing Glucarpidase in Primary Central Nervous System Lymphoma in 18 participants. Status unknown.

Timeline

15 September 2022

Primary endpoint
31 January 2025

31 July 2025

Quick facts

Lead sponsor	Assistance Publique - Hôpitaux de Paris
Phase	Phase 1
Status	Status unknown
Study type	INTERVENTIONAL
Allocation	na
Design	sequential
Masking	none
Primary purpose	treatment
Enrollment	18
Start date	15 September 2022
Primary completion	31 January 2025
Estimated completion	31 July 2025
Sites	1 location across France

Drugs / interventions tested

Glucarpidase (GLUCARPIDASE) — full drug profile →
Methotrexate (MTX) — full drug profile →

Conditions studied

Primary Central Nervous System Lymphoma — all drugs for Primary Central Nervous System Lymphoma →

Sponsor

Assistance Publique - Hôpitaux de Paris — full company profile →

Who can join

18 and older, any sex, with Primary Central Nervous System Lymphoma. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

High dose intravenous Methotrexate (HD-MTX) is the key drug in the treatment of primary central nervous system lymphoma (PCNSL). HD-MTX is usually delivered with time interval ranging from 10 to 21 days. Reduction of injection time interval is limited by MTX renal excretion and systemic toxicity. Glucarpidase (CPG2) is a recombinant bacterial rescue enzyme that cleaves circulating MTX into inactive metabolites, reducing plasma MTX concentrations within few minutes. The research hypothesis is that CPG2 used after HD-MTX injection allows to reduce time interval between MTX injections, increase dose intensity of the chemotherapy, reduce systemic toxicity and duration of hospitalization.

Publications & conference data

1 peer-reviewed publication reference this trial (live from Europe PMC):

Liquid biopsy for improving diagnosis and monitoring of CNS lymphomas: A RANO review.
Nayak L, Bettegowda C, Scherer F, Galldiks N, et al · · 2024 · cited 13× · PMID 38598668 · DOI 10.1093/neuonc/noae032

Verify or expand the search:

Other trials of Glucarpidase

Trials testing the same drug.

NCT03960177 — Glucarpidase After High-Dose Methotrexate in Patients With Osteosarcoma · EARLY_PHASE1 · active not recruiting

Other recruiting trials for Primary Central Nervous System Lymphoma

Currently open trials in the same condition.

NCT07350850 — A Multicenter Two-Cohort Study of Methotrexate, Rituximab, Sintilimab and Pirtobrutinib for Treatment-Naive PCNSL vs. Re · Phase 2 · recruiting
NCT06712810 — Q702 for the Treatment of Patients With Hematologic Malignancies · Phase 1 · recruiting
NCT06922604 — Glofitamab With Obinutuzumab Pre-treatment for the Treatment of Central Nervous System Lymphoma · Phase 1 · recruiting
NCT06832267 — Rituximab-Methotrexate-Temozolomide-Thiotepa (RMTT) Regimen As First-line Therapy for PCNS DLBCL · NA · recruiting
NCT06475235 — Pembrolizumab + Chemotherapy in Newly Diagnosed PCNSL · Phase 1 · recruiting

Other Assistance Publique - Hôpitaux de Paris trials

Trials by the same sponsor.

NCT07443436 — Immunomodulatory Treatment of Interstitial Lung Disease Associated With Surfactant Related Gene Variants · Phase 2 · not yet recruiting
NCT07499492 — Red Blood Cell Transfusion to Optimize Extubation · NA · not yet recruiting
NCT07379918 — Real-life Evaluation of Endopredict® in Early HR+/HER2- Breast Cancer · recruiting
NCT07473869 — Smartphone Application for Automated Measurement of Capillary Refill Time (CRT) · not yet recruiting
NCT07505394 — Efficacy of a Prediction Model-based Algorithm to PREVENT Drug-induced Impulse Control Disorders in Parkinson's Disease · NA · not yet recruiting

Verify against primary sources

ClinicalTrials.gov — authoritative US registry record
WHO ICTRP — international registry index
EU Clinical Trials Register
Sponsor press releases (Google)

Data sources for this page

Trial protocol + status: ClinicalTrials.gov NCT05135858 (US National Library of Medicine, public domain)
Publications: Europe PMC API search by NCT ID, retrieved 10 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 Assistance Publique - Hôpitaux de Paris
Last refreshed: 25 October 2022

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/NCT05135858.

Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing