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Recruiting NCT05317494

A Study to Assess Change in Disease State in Adult Participants With Acute Myeloid Leukemia (AML) Ineligible for Intensive Chemotherapy Receiving Oral Venetoclax Tablets in Greece

— Observational Acute Myeloid Leukemia

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
This is an observational study: the protocol does not assign a study treatment.
Who it may be relevant to
Registry conditions: Acute Myeloid Leukemia. Basic parameters: from 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Greece
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

A Prospective Non-Interventional Study to Describe the Effectiveness and Safety of Venetoclax as a First-Line Treatment in Acute Myeloid Leukemia (AML) Patients Who Are Ineligible to Intensive Chemotherapy in Routine Clinical Practice in Greece

Overview

Acute Myeloid Leukemia (AML) is a cancer of the blood and bone marrow and is the most common acute leukemia in adults. This study will evaluate how well Venetoclax works to treat AML in adult participants who are ineligible for intensive chemotherapy in Greece. Venetoclax is a drug approved to treat Acute Myeloid Leukemia. All study participants will receive Venetoclax as prescribed by their study doctor in accordance with approved local label. Adult participants with a new diagnosis of AML who are ineligible for intensive chemotherapy will be enrolled. Around 100 participants will be enrolled in the study in approximately 15 sites in Greece. Participants will receive venetoclax tablets to be taken by mouth daily according to the approved local label. The duration of the study is approximately 30 months. There is expected to be no additional burden for participants in this trial. All study visits will occur during routine clinical practice and participants will be followed for 30 months.

Primary outcome measures

  • Percentage of Participants Achieving Overall Survival (OS) [Time frame: Up to 30 Months]
Secondary outcome measures (12)
  • Percentage of Participants Achieving Composite Complete Remission [Time frame: Up to 30 Months]
  • Total Time of Treatment with Venetoclax Combination Therapy [Time frame: Up to 30 Months]
  • Time to Transfusion Independence [Time frame: Up to 30 Months]
  • Post Baseline RBC and Platelet Transfusion Independence Rate [Time frame: Up to 30 Months]
  • Change from Baseline in European Quality of Life 5 Dimensions (EQ-5D-5L) Considered Minimally Clinical Important [Time frame: Up to 30 Months]
  • Treatment Patterns Venetoclax in Combination with Hypomethylating Agents (HMAs) [Time frame: Up to 30 Months]
  • Healthcare Resource Utilization as the Number of Transfusions (Red Blood Cell [RBC] or Platelets) Received during First-line Treatment in an Outpatient Setting [Time frame: Up to 30 Months]
  • Healthcare Resource Utilization as the Number of Hospitalizations during First-line Treatment [Time frame: Up to 30 Months]
  • Healthcare Resource Utilization as the Number of Intensive Care Unit (ICU) Admissions during First-line Treatment [Time frame: Up to 30 Months]
  • Healthcare Resource Utilization as the Number of Visits in a Private Healthcare Practitioner [Time frame: Up to 30 Months]
  • Healthcare Resource Utilization as the Name of Relevant Medication due to Infections (Antibiotics or Other) [Time frame: Up to 30 Months]
  • Healthcare Resource Utilization as the Dosing Scheme of Relevant Medication due to Infections (Antibiotics or Other) [Time frame: Up to 30 Months]

Eligibility criteria

Inclusion criteria

  • Participant diagnosed Acute Myeloid Leukemia (AML) who is ineligible to intensive chemotherapy and is eligible to receive venetoclax as a first-line therapy, as per Greek Ministry of Health (MOH) label.
  • Physician has decided to initiate venetoclax treatment. The decision to treat with venetoclax is made by the physician in accordance with the local label prior to any decision to approach the patient to participate in this study.

Exclusion criteria

\- Participating in an interventional clinical trial within 30 days prior to venetoclax treatment initiation.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Observational model
Cohort

Study locations

Greece · 13 centers
  • Olympion General Clinic /ID# 268392 — Pátrai
  • General Hospital of Athens Gennimatas /ID# 245968 — Athens
  • General Hospital of Athens Laiko /ID# 244338 — Athens
  • University General Hospital Attikon /ID# 248265 — Athens
  • University General Hospital of Heraklion PA.G.N.I /ID# 244337 — Heraklion
  • General University Hospital of Alexandroupolis /ID# 244235 — Alexandroupoli
  • General Hospital of Athens Evaggelismos and Ophthalmiatrio of Athens Polyclinic /ID# 24433 — Athens
  • General Anti-cancer Hospital Agios Savvas /ID# 244408 — Athens
  • … and 5 more centers

Identifiers

NCT: NCT05317494 · P22-535

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗