{
  "id": "ctis:2024-518494-34-00",
  "euct": "2024-518494-34-00",
  "title": "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",
  "publicTitle": "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",
  "fullTitle": "A prospective, multicenter, phase II trial to assess the efficacy and safety of MRD-driven treatment with VEnetoclax and RItuximab combination in previously unTreated pAtients with chronic lymphocytic leukemia (VERITA PALG-CLL5 study)",
  "shortTitle": "VERITA PALG-CLL5",
  "status": "Authorised",
  "statusCode": "5",
  "startDateEU": "2022-02-24",
  "decisionDate": "2024-12-02T15:06:42.686",
  "publishDate": "2024-12-03T02:09:26.760320031",
  "trialRegion": "EEA",
  "trialRegionCode": "1",
  "medicalConditions": [
    {
      "name": "Chronic lymphocytic leukemia",
      "rareDisease": false
    }
  ],
  "therapeuticAreas": [
    {
      "code": "4",
      "name": "Diseases [C] - Neoplasms [C04]"
    }
  ],
  "trialCategory": {
    "phaseCode": "4",
    "categoryCode": "2",
    "lowIntervention": false
  },
  "duration": {
    "estimatedRecruitmentStartDate": "2022-02-24",
    "estimatedEndDate": "2027-07-31",
    "estimatedGlobalEndDate": null
  },
  "countries": [
    {
      "name": "Poland",
      "publicStatusCode": "5",
      "firstDecisionDate": "2024-12-02T15:06:42.686",
      "lastDecisionDate": "2024-12-02T15:06:42.686",
      "history": [
        {
          "source": "application_country_status",
          "applicationBusinessKey": "IN",
          "applicationType": "INITIAL",
          "status": "Authorised",
          "trialStatus": "Authorised",
          "decision": "authorized",
          "assessmentOutcome": "acceptable",
          "assessmentOutcomeDate": "2024-11-28",
          "date": "2024-12-02",
          "reportingStatusCode": "Authorised",
          "applicationStatusCode": "Authorised"
        },
        {
          "source": "application_decision",
          "applicationBusinessKey": "IN",
          "applicationType": "INITIAL",
          "status": "Authorised",
          "trialStatus": "Authorised",
          "decision": "authorized",
          "assessmentOutcome": "acceptable",
          "eventType": "decision",
          "date": "2024-12-02T15:06:42.686",
          "isRMS": true
        }
      ]
    }
  ],
  "applications": [
    {
      "id": "application:2024-518494-34-00:in",
      "businessKey": "IN",
      "type": "INITIAL",
      "status": "Authorised",
      "trialStatus": "Authorised",
      "submissionDate": "2024-10-08",
      "decisionDate": "2024-12-02",
      "decisions": [
        {
          "mscName": "Poland",
          "decisionDate": "2024-12-02T15:06:42.686",
          "decision": "authorized",
          "assessmentOutcome": "acceptable",
          "eventType": "decision",
          "applicationType": "INITIAL",
          "isRMS": true
        }
      ],
      "countryStatuses": [
        {
          "countryName": "Poland",
          "mscName": "Poland",
          "trialStatus": "Authorised",
          "decision": "authorized",
          "decisionDate": "2024-12-02",
          "firstDecisionDate": "2024-12-02",
          "assessmentOutcome": "acceptable",
          "assessmentOutcomeDate": "2024-11-28",
          "reportingStatusCode": "Authorised",
          "applicationStatusCode": "Authorised"
        }
      ]
    }
  ],
  "evidence": [
    {
      "id": "evidence:3fa258989f45d97cdcb7d57c",
      "path": "authorizedApplication.authorizedPartI.trialDetails.trialInformation.endPoint.secondaryEndPoints[8].endPoint",
      "term": "machine learning",
      "snippet": "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…"
    }
  ],
  "official": {
    "retrieveUrl": "https://euclinicaltrials.eu/ctis-public-api/retrieve/2024-518494-34-00",
    "publicUrl": "https://euclinicaltrials.eu/ctis-public/view/2024-518494-34-00?lang=en"
  },
  "slug": "2024-518494-34-00",
  "firstObservedAt": "2026-07-23T11:19:41.794Z",
  "lastObservedAt": "2026-07-23T13:03:56.000Z",
  "dateModified": "2026-07-23",
  "materialFingerprint": "b6ccd757e5c047477baa6c78e790ecd68881dd40e8974446de13bd8725d264b5"
}