NCT05036564 (DOROTHEA) is a NA clinical trial of Lumbar puncture in Primary CNS Lymphoma, sponsored by IRCCS San Raffaele.

Who is sponsoring NCT05036564?

NCT05036564 is sponsored by IRCCS San Raffaele.

What drugs are being tested in NCT05036564?

Interventions in NCT05036564: Lumbar puncture.

What condition does NCT05036564 study?

NCT05036564 studies Primary CNS Lymphoma.

Is NCT05036564 still recruiting?

NCT05036564 is currently recruiting now. Last updated 31 May 2025.

Last reviewed 2025-05-31 · How we verify

NCT05036564: DOROTHEA

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

Diagnosis; Objective RespOnse; THErApy

Recruiting now NA Last updated 31 May 2025

What this trial tests

NA trial testing Lumbar puncture in Primary CNS Lymphoma in 70 participants. Currently enrolling.

Timeline

16 October 2020

Primary endpoint
31 July 2026

30 April 2027

Quick facts

Lead sponsor	IRCCS San Raffaele
Phase	NA
Status	Recruiting now
Study type	INTERVENTIONAL
Allocation	non randomized
Design	parallel
Masking	none
Primary purpose	diagnostic
Enrollment	70
Start date	16 October 2020
Primary completion	31 July 2026
Estimated completion	30 April 2027
Sites	1 location across Italy

Drugs / interventions tested

Lumbar puncture — full drug profile →

Conditions studied

Primary CNS Lymphoma — all drugs for Primary CNS Lymphoma →

Sponsor

IRCCS San Raffaele — full company profile →

Who can join

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

Sponsor's own description

Thi is a prospective and low-intervention clinical trial. We propose to design a panel of "core" genetic alterations by sequencing Cerebral Spinal Fluid (CSF) DNA in patients with confirmed or suspicious Primary Central Neurvous System Lymphoma (PCNSL) with the aim to improve diagnostic sensitivity, response assessment and monitoring early CNS relapse in routine practice. Enrolled patients will receive conventional treatments according to well-established international guidelines, DNA assessments will not influence the treatment choices.

Publications & conference data

2 peer-reviewed publications reference this trial (live from Europe PMC):

Prevention and management of secondary central nervous system lymphoma.
Bobillo S, Khwaja J, Ferreri AJM, Cwynarski K. · · 2023 · cited 47× · PMID 36384246 · DOI 10.3324/haematol.2022.281457
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 Lumbar puncture

Trials testing the same drug.

NCT06353412 — Current Treatment Methods of Idiopathic Intracranial Hypertension · not yet recruiting
NCT05399602 — The Role of Neurofilament Light (NfL) in Patients With Hydrocephalus · NA · completed
NCT06083233 — Role of Brain Specific Biomarkers in Hydrocephalus · completed
NCT05806697 — Investigation of AlzHeimer's Predictors in Subjective Memory Complainers - Extension Study · NA · recruiting
NCT05516732 — Serotonin Release in Premotor and Motor PD · recruiting

Other recruiting trials for Primary CNS Lymphoma

Currently open trials in the same condition.

NCT05518383 — B-cell Mature Non-Hodgkin's Lymphoma Treatment Protocol in Children and Adolescents 2021 · Phase 4 · recruiting
NCT04947319 — Study of Tirabrutinib (ONO-4059) in Patients With Primary Central Nervous System Lymphoma (PROSPECT Study) · Phase 2 · active not recruiting
NCT04627753 — Study of Lenalidomide/Rituximab Maintenance for Transplantation Ineligible Patients With PCNSL. · Phase 2 · recruiting
NCT04006561 — Prospective Neurobehavioral Functions in Newly-diagnosed Patients With Primary CNS Lymphoma Treated With Hyperfractionat · recruiting

Other IRCCS San Raffaele trials

Trials by the same sponsor.

NCT07454759 — Acute Sarcopenia in Hospitalized Older Adults · not yet recruiting
NCT07456462 — Making Antibody Treatments More Effective in Early Alzheimer's Disease Using 3Tesla Magnetica Resonance · NA · not yet recruiting
NCT07066878 — This Protocol Focuses on the Factors That Influence Survival, the Development of Complications and the Quality of Life B · not yet recruiting
NCT07526298 — Anticipating Irreversible Disability in Neuromyelitis Optica Spectrum Disorder: a Study to Assess Disease Activity in Ap · not yet recruiting
NCT07426471 — Delafloxacin Plasma and Tissue Concentration in Patients With Skin, Soft Tissue, and Bone and Joint Infections. · 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 NCT05036564 (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 IRCCS San Raffaele
Last refreshed: 31 May 2025

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/NCT05036564.

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