← Back to the studies fieldPERMANENT CTIS TRIAL DOSSIER

2024-518494-34-00

Clinical trial conducted to evaluate the effectiveness of a combination of drugs called venetoclax and rituximab adapted to the state of minimal residual disease in patients with untreated chronic lymphocytic leukemia

Public registry stateAuthorised

CLAIM BOUNDARY

This dossier documents a medicinal trial—not proof of efficacy.

Registration, authorisation of a trial application, trial start, result disclosure and marketing authorisation are different facts. The dossier claims neither clinical efficacy nor safety, deployment or causality.

CTIS record ≠ efficacy ≠ marketing authorisation

REGISTRY FACTS

What CTIS publishes about this trial

EUCT number: 2024-518494-34-00
Trial status: Authorised
Sponsor: not published
Trial region: EEA
Phase: 4
Trial category: 2
Low-intervention trial: no
Estimated EU start: 24 February 2022
Decision date: 02 December 2024
Published: 03 December 2024
Estimated end: 31 July 2027

EXACT AI EVIDENCE

The original text determines inclusion.

Terms count only in allowlisted public CTIS fields. Sponsor, medical condition, phase or a generic software reference alone is not AI evidence.

“To develop innovative, machine-learning-based algorithms to assess the prediction of response to VR treatment in CLL (as a probability of selected categories of response supported by rationale) based on patients’ electr…”

Source field: authorizedApplication.authorizedPartI.trialDetails.trialInformation.endPoint.secondaryEndPoints[8].endPoint
Matched term: machine learning

MEDICAL CONTEXT

Conditions and therapeutic areas

Reported medical conditions

Chronic lymphocytic leukemia

Therapeutic areas

Diseases [C] - Neoplasms [C04]4

COUNTRY TRACKS

Every country retains its own published state.

A status in one country is not transferred to another. Decision dates and status histories remain separate source facts.

Poland

Authorised

First decision: 02 December 2024
Latest decision: 02 December 2024

02 December 2024Authorised
02 December 2024Authorised

TRIAL APPLICATIONS

Submission, decision and country state remain separate

INITIAL

Authorised

Trial status: Authorised
Submitted: 08 October 2024
Decided: 02 December 2024

Decisions02 December 2024 · Authorized

Country statusPoland · Authorised

SOURCE-DATED CHRONICLE

Official dates, not an efficacy narrative.

The chronicle sorts published CTIS events. i6eal observation times follow on a separate clock.

08 October 2024Application Submitted
Application IN · Authorised
28 November 2024Country Assessment
Poland · Application IN · Authorized
02 December 2024Application Status
Application IN · Authorised
02 December 2024Country Decision
Poland · Application IN · Authorized
23 July 2026Trial Status Observed
Authorised

Observed by i6eal

First observed: 23 Jul 2026, 13:19
Last observed: 23 Jul 2026, 15:03
Materially modified: 23 July 2026

RESULT DISCLOSURE

Disclosure is a separate registry fact.

No result disclosure is published in this projection. This means neither that results do not exist nor that a deadline has been missed.

PROVENANCE

From the dossier back to the official record

The public CTIS record remains authoritative. The i6eal files are a deterministic, bounded projection.

Open public CTIS record ↗Open CTIS retrieval source ↗Machine-readable dossier · JSON ↓Structured metadata · JSON-LD ↓

i6eal (2026): EU AI Studies Monitor, CTIS trial 2024-518494-34-00, data state 23 July 2026. https://i6eal.de/en/tools/ki-studienmonitor/studie/2024-518494-34-00/