Assessing the effectiveness of Venetoclax for treating Acute Myeloid Leukemia in Greece
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
This study is testing if Venetoclax can help adults with Acute Myeloid Leukemia who can't have intensive chemotherapy feel better.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 100 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | AbbVie Industry-sponsored |
| Drugs / interventions | chemotherapy |
| Locations | 13 sites (Pátrai, Achaia and 12 other locations) |
| Trial ID | NCT05317494 on ClinicalTrials.gov |
What this trial studies
This study evaluates the effectiveness of Venetoclax in treating adult patients diagnosed with Acute Myeloid Leukemia (AML) who are not eligible for intensive chemotherapy. Participants will receive Venetoclax tablets daily as prescribed by their physician, following the approved local label. The study aims to enroll around 100 participants across approximately 15 sites in Greece and will monitor their disease state over a period of 30 months. All study visits will coincide with routine clinical practice, minimizing additional burdens on participants.
Who should consider this trial
Good fit: Ideal candidates are adults diagnosed with Acute Myeloid Leukemia who are ineligible for intensive chemotherapy and are eligible for Venetoclax treatment.
Not a fit: Patients currently participating in another interventional clinical trial may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could provide a new treatment option for patients with AML who cannot undergo intensive chemotherapy.
How similar studies have performed: Previous studies have shown promising results with Venetoclax in treating AML, indicating that this approach has potential based on existing evidence.
Eligibility criteria
Show full inclusion / exclusion 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.
Where this trial is running
Pátrai, Achaia and 12 other locations
- Olympion General Clinic /ID# 268392 — Pátrai, Achaia, Greece (Active_not_recruiting)
- General Hospital of Athens Gennimatas /ID# 245968 — Athens, Attica, Greece (Active_not_recruiting)
- General Hospital of Athens Laiko /ID# 244338 — Athens, Attica, Greece (Active_not_recruiting)
- University General Hospital Attikon /ID# 248265 — Athens, Attica, Greece (Active_not_recruiting)
- University General Hospital of Heraklion PA.G.N.I /ID# 244337 — Heraklion, Crete, Greece (Completed)
- General University Hospital of Alexandroupolis /ID# 244235 — Alexandroupoli, Greece (Active_not_recruiting)
- General Hospital of Athens Evaggelismos and Ophthalmiatrio of Athens Polyclinic /ID# 244339 — Athens, Greece (Active_not_recruiting)
- General Anti-cancer Hospital Agios Savvas /ID# 244408 — Athens, Greece (Active_not_recruiting)
- General Hospital of Athens Laiko - Hematology Location /ID# 244234 — Athens, Greece (Active_not_recruiting)
- University General Hospital of Ioannina /ID# 244336 — Ioannina, Greece (Active_not_recruiting)
- University General Hospital of Patras /ID# 244335 — RION Patras Achaia, Greece (Completed)
- Papageorgiou General Hospital /ID# 248266 — Thessaloniki, Greece (Recruiting)
- General Hospital of Thessaloniki George Papanikolaou /ID# 244237 — Thessaloniki, Greece (Active_not_recruiting)
Study contacts
- Study coordinator: Abbvie Call Center
- Email: abbvieclinicaltrials@abbvie.com
- Phone: 844-663-3742
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.