NCT04841434 (VALIDATE) is a Phase 1, PHASE2 clinical trial of Voraxaze Injectable Product in CNS Lymphoma, sponsored by Charite University, Berlin, Germany.

Who is sponsoring NCT04841434?

NCT04841434 is sponsored by Charite University, Berlin, Germany.

What drugs are being tested in NCT04841434?

Interventions in NCT04841434: Voraxaze Injectable Product.

What condition does NCT04841434 study?

NCT04841434 studies CNS Lymphoma.

Is NCT04841434 still recruiting?

NCT04841434 is currently completed. Last updated 6 January 2025.

Last reviewed 2025-01-06 · How we verify

NCT04841434: VALIDATE

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

A Phase I/II Study to Investigate the Use of VORAXAZE™ As Intended Intervention in Patients with CNSL

Completed Phase 1, PHASE2 Last updated 6 January 2025

What this trial tests

Phase 1, PHASE2 trial testing Voraxaze Injectable Product in CNS Lymphoma in 18 participants. Completed in 1 December 2024.

Timeline

1 June 2021

Primary endpoint
1 December 2024

1 December 2024

Quick facts

Lead sponsor	Charite University, Berlin, Germany
Phase	Phase 1, PHASE2
Status	Completed
Study type	INTERVENTIONAL
Allocation	na
Design	single group
Masking	none
Primary purpose	treatment
Enrollment	18
Start date	1 June 2021
Primary completion	1 December 2024
Estimated completion	1 December 2024
Sites	1 location across Germany

Drugs / interventions tested

Voraxaze Injectable Product — full drug profile →

Conditions studied

CNS Lymphoma — all drugs for CNS Lymphoma →

Sponsor

Charite University, Berlin, Germany

Who can join

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

Sponsor's own description

This phase I-II trial is intented to demonstrate tolerability (i.e. absence of severe non-hematological toxicity) and efficacy of intended intervention with repeated doses of Voraxaze, in addition to leucovorin (LV), in patients with renal impairment or renal failure during previous HD-MTX therapy. Patients will receive up to 6 cycles of HD-MTX treatment with 14 days between cycles (a maximum delay of 28 days is permitted in order to allow time for a patient to recover from the previous cycle).

Publications & conference data

No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.

Verify or expand the search:

Other recruiting trials for CNS Lymphoma

Currently open trials in the same condition.

NCT06730542 — Zanubrutinib in Combination With Pola-R-CHP and High-dose Methotrexate in Patients With Secondary CNS Lymphoma · Phase 1 · recruiting
NCT06343311 — T-Cell Therapy (EB103) in Adults With Relapsed/Refractory B-Cell Non-Hodgkin's Lymphoma (NHL) · Phase 1, PHASE2 · recruiting
NCT06876688 — Relma-cel Followed by Tislelizumab for the Treatment of Relapsed/Refractory CNS Large B-Cell Lymphoma · Phase 2 · recruiting
NCT06132737 — [90Y]Y-PTT Endoradiotherapy in CNS Lymphoma Patients · Phase 1, PHASE2 · recruiting
NCT05926427 — Orelabrutinib Combined With Rituximab and Chemotherapy for Relapsed/Refractory B-Cell Lymphoma Patients With Central Ner · Phase 2 · recruiting

Other Charite University, Berlin, Germany trials

Trials by the same sponsor.

NCT07486167 — Influence of Lung Volume Optimization Maneuver on Cardiac Output and Lung Compliance in Ventilated Children With Congeni · Phase 1, PHASE2 · not yet recruiting
NCT07476729 — International Study for Treatment of Childhood Relapsed Precursor B-Cell ALL 2020 (IntReALL BCP 2020) · Phase 3 · not yet recruiting
NCT07503054 — Ovarian Cancer Screening and AI · NA · not yet recruiting
NCT07529197 — Observational Study on Immunoadsorption (IA) in Patients With Autoantibody-Positive Post-Infectious ME/CFS · recruiting
NCT07388693 — Feasibility of Integrating Olfactory Stimuli Into Virtual Reality Cue Exposure for Patients With Alcohol Dependence · NA · 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 NCT04841434 (US National Library of Medicine, public domain)
Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
Sponsor: as reported to ClinicalTrials.gov by Charite University, Berlin, Germany
Last refreshed: 6 January 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/NCT04841434.

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