Acute Myeloid LeukemiaSURVIVENCT05317494
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
An observational study of Acute Myeloid Leukemia, run by AbbVie at 13 sites in Greece.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Acute Myeloid Leukemia
- How many people
- 106 participants
- Where
- 13 sitesGreece
- Study dates
- 26 May 2022to 29 May 2026
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Adult participants with acute myeloid leukemia (AML) treated with venetoclax per approved local label in Greece.
Who may be able to join
- 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.
Who cannot join
- Participating in an interventional clinical trial within 30 days prior to venetoclax treatment initiation.
Trial locations and contacts
13 sites in 1 country.
13 sites in 1 country
Greece13 sites
General University Hospital of Alexandroupolis /ID# 244235
Alexandroupoli, 68100
General Hospital of Athens Gennimatas /ID# 245968
Athens, Attica, 11527
General Hospital of Athens Laiko /ID# 244338
Athens, Attica, 11527
General Hospital of Athens Evaggelismos and Ophthalmiatrio of Athens Polyclinic /ID# 244339
Athens, 10676
General Anti-cancer Hospital Agios Savvas /ID# 244408
Athens, 11522
General Hospital of Athens Laiko - Hematology Location /ID# 244234
Athens, 11527
University General Hospital Attikon /ID# 248265
Chaïdári, Attica, 12462
University General Hospital of Heraklion PA.G.N.I /ID# 244337
Heraklion, Crete, 71500
University General Hospital of Ioannina /ID# 244336
Ioannina, 45500
Olympion General Clinic /ID# 268392
Pátrai, Achaia, 26443
University General Hospital of Patras /ID# 244335
RION Patras Achaia, 26504
Papageorgiou General Hospital /ID# 248266
Thessaloniki, 56429
General Hospital of Thessaloniki George Papanikolaou /ID# 244237
Thessaloniki, 57010
About this study
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
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.
Read more
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.
- Conditions
- Acute Myeloid Leukemia
- Keywords
- Acute Myeloid Leukemia, Venetoclax, Venclexta, Venclyxto, ABT-199, Cancer
- Medical subject headings
- Leukemia, Myeloid, Acute, Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Venetoclax Participants | Participants treated with Venetoclax in accordance with approved local label. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percentage of Participants Achieving Overall Survival (OS)
OS is defined as the time from treatment initiation to death from any cause.
Measured: Up to 30 Months
Secondary outcomes (14)
Percentage of Participants Achieving Composite Complete Remission
Composite complete remission is defined as the proportion of participants with complete remission (CR) or complete remission with incomplete marrow recovery (CRi).
Measured: Up to 30 Months
Total Time of Treatment with Venetoclax Combination Therapy
The total time of treatment with venetoclax combination therapy.
Measured: Up to 30 Months
Time to Transfusion Independence
Total duration of transfusion independence is defined as the period of at least 56 days with no Red Blood Cell (RBC) or platelet transfusion between the first dose of study drug and the last dose of study drug plus 30 days.
Measured: Up to 30 Months
Post Baseline RBC and Platelet Transfusion Independence Rate
Post baseline RBC and platelet transfusion independence rate will be calculated as the proportion of participants who achieved RBC and platelet, respectively, transfusion independence post baseline.
Measured: Up to 30 Months
Change from Baseline in European Quality of Life 5 Dimensions (EQ-5D-5L) Considered Minimally Clinical Important
The EQ-5D-5L is a standardized instrument used to measure health-related quality of life that can be used in a wide range of health conditions and treatments.
Measured: Up to 30 Months
Treatment Patterns Venetoclax in Combination with Hypomethylating Agents (HMAs)
Treatment patterns defined by the proportion of participants treated with venetoclax in combination with HMAs (dosing with venetoclax and any modifications/interruptions/titrations, type and dosing of each HMA, frequency of response assessment, cycle length, dosing, concomitant medications, etc).
Measured: 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
Healthcare resource utilization as the number of transfusions (red blood cell [RBC] or platelets) received during first-line treatment in an outpatient setting.
Measured: Up to 30 Months
Healthcare Resource Utilization as the Number of Hospitalizations during First-line Treatment
Healthcare resource utilization as the number of hospitalizations during first-line treatment.
Measured: Up to 30 Months
Healthcare Resource Utilization as the Number of Intensive Care Unit (ICU) Admissions during First-line Treatment
Healthcare resource utilization as the number of intensive care unit (ICU) admissions during first-line treatment.
Measured: Up to 30 Months
Healthcare Resource Utilization as the Number of Visits in a Private Healthcare Practitioner
Healthcare resource utilization as the number of visits in a private healthcare practitioner.
Measured: Up to 30 Months
Healthcare Resource Utilization as the Name of Relevant Medication due to Infections (Antibiotics or Other)
Healthcare resource utilization as the name of relevant medication due to infections (antibiotics or other).
Measured: Up to 30 Months
Healthcare Resource Utilization as the Dosing Scheme of Relevant Medication due to Infections (Antibiotics or Other)
Healthcare resource utilization as the dosing scheme of relevant medication due to infections (antibiotics or other).
Measured: Up to 30 Months
Healthcare Resource Utilization as the Number of Laboratory Tests
Healthcare resource utilization as the number of laboratory tests.
Measured: Up to 30 Months
Healthcare Resource Utilization as the Type of Laboratory Tests
Healthcare resource utilization as the type of laboratory tests.
Measured: Up to 30 Months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Apr 2022
- Study start26 May 2022
- Primary completion29 May 2026
- Study completion29 May 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Acute Myeloid LeukemiaStudies of the same condition, open and under way.
- More trials run by AbbVieThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 106 participants (actual)
Sponsor and investigators
- Lead sponsor
- AbbVie
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- ABBVIE INC., Study director, AbbVie
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05317494
- Sponsor's protocol ID
- P22-535
- Acronym
- SURVIVE
- Status last verified
- Sep 2026
- First submitted
- 21 Mar 2022
- Last updated
- 2 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 2 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT05317494
- Acronym / sponsor ID
- SURVIVE / P22-535
- Conditions
- Acute Myeloid Leukemia
- Keywords
- Acute Myeloid Leukemia, Venetoclax, Venclexta, Venclyxto, ABT-199, Cancer
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 106 participants (actual)
- Lead sponsor
- AbbVieIndustry (pharma, biotech, devices)
- Study start
- 26 May 2022 (actual)
- Primary completion
- 29 May 2026 (actual)
- Study completion
- 29 May 2026 (actual)
- First posted
- 7 Apr 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Venetoclax Participants | – | –Participants treated with Venetoclax in accordance with approved local label. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Adult participants with acute myeloid leukemia (AML) treated with venetoclax per approved local label in Greece.
Key inclusion criteria (2 listed)
- 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.
Key exclusion criteria (1 listed)
- Participating in an interventional clinical trial within 30 days prior to venetoclax treatment initiation.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Percentage of Participants Achieving Overall Survival (OS)
Time frame: Up to 30 Months
OS is defined as the time from treatment initiation to death from any cause.
14 secondary outcomes
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
Healthcare Resource Utilization as the Number of Laboratory Tests
Time frame: Up to 30 Months
Healthcare Resource Utilization as the Type of Laboratory Tests
Time frame: Up to 30 Months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Oct 2026.
- Related Info.Link provided by the sponsor.
- Individual participant dataSharing planned: Undecided
Related trials for Acute Myeloid Leukemia
RecruitingPhase 1
A Study of CHM-029 in Participants With NPM1 Mutated, KMT2A or NUP98 Rearranged AML
AML (Acute Myeloid Leukemia)
RecruitingPhase 2
Testing New Therapies for Patients With Acute Myeloid Leukemia Who Are Newly Diagnosed and Have Not Yet Started Treatment (A MyeloMATCH Treatment Trial)
Acute Myeloid Leukemia, Acute Myeloid Leukemia Arising From Previous Myelodysplastic/Myeloproliferative Neoplasm
Active, not recruitingPhase 2
Clofarabine and Melphalan Before Donor Stem Cell Transplant in Treating Patients With Myelodysplasia, Acute Leukemia in Remission, or Chronic Myelomonocytic Leukemia
Adult Acute Lymphoblastic Leukemia in Remission, Acute Myeloid Leukemia Arising From Previous Myelodysplastic Syndrome
RecruitingPhase 1/2
Venetoclax and CLAG-M for the Treatment of Acute Myeloid Leukemia and High-Grade Myeloid Neoplasms
Acute Biphenotypic Leukemia, Acute Myeloid Leukemia
Not yet recruitingPhase 1
ATRN-119 in Combination With Decitabine in Patients With TP53-Mutated AML or Higher-Risk MDS
Acute Myeloid Leukemia, High-risk Myelodysplastic Syndrome
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
ABBVIE INC. study director
AbbVie
13 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Acute Myeloid Leukemia, run by AbbVie at 13 sites in Greece.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 2 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 13 sites in Greece. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Percentage of Participants Achieving Overall Survival (OS) (time frame: Up to 30 Months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Oct 2026.