Acute Myeloid LeukemiaVALORNCT05215639
A Study to Assess Change in Disease State in Adult Participants With Acute Myeloid Leukemia (AML) Ineligible for Intensive Chemotherapy in Switzerland and Austria Receiving Oral Venetoclax Tablets
An observational study of Acute Myeloid Leukemia, run by AbbVie at 19 sites in 2 countries.
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 Switzerland \& Austria. 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
- 120 participants
- Where
- 19 sitesin 2 countries
- Study dates
- 27 Dec 2021to 24 Nov 2025
- 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 Switzerland \& Austria.
Who may be able to join
- Newly-diagnosed AML and eligible to receive venetoclax as per local 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
19 sites in 2 countries.
19 sites in 2 countries
Switzerland12 sites
Kantonsspital Aarau AG /ID# 251598
Aarau, Canton of Aargau, 5001
Kantonsspital Baden /ID# 241896
Baden, Canton of Aargau, 5404
Duplicate_Universitätsspital Basel /ID# 256509
Basel, Canton of Basel-City, 4031
EOC Ospedale Regionale di Bellinzona e Valli /ID# 240663
Bellinzona, Canton Ticino, 6500
Inselspital, Universitaetsspital Bern /ID# 239241
Bern, 3010
Spitalzentrum Oberwallis /ID# 241897
Brig, Valais, 3900
Luzerner Kantonsspital /ID# 239242
Lucerne, Canton of Lucerne, 6000
Hôpital de Nyon /ID# 240720
Nyon, 1260
Hôpital du Chablais, Rennaz /ID# 241895
Rennaz, Canton of Vaud, 1847
Kantonsspital St. Gallen /ID# 239233
Sankt Gallen, Canton of St. Gallen, 9007
KSW Kantonsspital Winterthur /ID# 239852
Winterthur, Canton of Zurich, 8400
Hirslanden Klinik /ID# 239239
Zurich, Canton of Zurich, 8032
Austria7 sites
Krankenhaus der Barmherzigen Brueder Graz /ID# 254121
Graz, Styria, 8020
Klinikum Klagenfurt am Wörthersee /ID# 247304
Klagenfurt, Carinthia, 9020
Landeskrankenhaus Hochsteiermark, Standort Leoben /ID# 254174
Leoben, Styria, 8700
Ordensklinikum Linz GmbH Elisabethinen /ID# 247284
Linz, Upper Austria, 4010
Universitaetsklinikum St. Poelten /ID# 247283
Sankt Pölten, Lower Austria, 3100
Klinik Ottakring /ID# 247285
Vienna, State of Vienna, 1160
Hanusch Krankenhaus /ID# 247282
Vienna, 1140
About this study
Official title: Venetoclax AML Observational Real-World Study of Treatment-naïve Patients Ineligible for Intensive Chemotherapy in Switzerland & Austria
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 Switzerland \& Austria.
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 120 participants will be enrolled in the study in approximately 15 sites in Switzerland \& Austria.
Read more
Participants will receive venetoclax tablets to be taken by mouth daily according to the approved local label. The duration of the study is approximately 24 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 24 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 Month 24
Secondary outcomes (5)
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 Month 24
Time to Transfusion Independence
Time to transfusion independence is defined as the time between the date of first venetoclax intake and the absence of any Red Blood Cell (RBC) or platelet transfusion during any consecutive 8 and/or 16 weeks during the treatment period and percentage of participants achieving transfusion independence.
Measured: Up to Month 24
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 Month 24
Change from Baseline in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ-C30) Considered Minimally Clinical Important
The EORTC QLQ-C30 is developed to assess the quality of life of cancer patients and is based on multi-item and single-item scales. The core questionnaire contains 5 functional scales, 3 symptom scales, 1 global health status scale, as well as 6 single-item measures.
Measured: Up to Month 24
Treatment Patterns Venetoclax in Combination with Hypomethylating Agents (HMAs) and in Switzerland in combination with Low Dose Cytarabine (LDAC)
Treatment patterns defined by the proportion of participants treated with venetoclax in combination with HMAs and in Switzerland in combination with LDAC.
Measured: Up to Month 24
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Jan 2022
- Study start27 Dec 2021
- Primary completion24 Nov 2025
- Study completion24 Nov 2025
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
- 120 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
- NCT05215639
- Sponsor's protocol ID
- P21-937
- Acronym
- VALOR
- Status last verified
- Dec 2025
- First submitted
- 19 Jan 2022
- Last updated
- 10 Dec 2025
- 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 10 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Venetoclax AML Observational Real-World Study of Treatment-naïve Patients Ineligible for Intensive Chemotherapy in Switzerland & Austria
- ClinicalTrials.gov ID
- NCT05215639
- Acronym / sponsor ID
- VALOR / P21-937
- Conditions
- Acute Myeloid Leukemia
- Keywords
- Acute Myeloid Leukemia, Venetoclax, Venclexta, Venclyxto, ABT-199, Cancer
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 120 participants (actual)
- Lead sponsor
- AbbVieIndustry (pharma, biotech, devices)
- Study start
- 27 Dec 2021 (actual)
- Primary completion
- 24 Nov 2025 (actual)
- Study completion
- 24 Nov 2025 (actual)
- First posted
- 31 Jan 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 Switzerland \& Austria.
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 120 participants will be enrolled in the study in approximately 15 sites in Switzerland \& Austria.
Participants will receive venetoclax tablets to be taken by mouth daily according to the approved local label. The duration of the study is approximately 24 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 24 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 Switzerland \& Austria.
Key inclusion criteria (2 listed)
- Newly-diagnosed AML and eligible to receive venetoclax as per local 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 Month 24
OS is defined as the time from treatment initiation to death from any cause.
5 secondary outcomes
Percentage of Participants Achieving Composite Complete Remission
Time frame: Up to Month 24
Time to Transfusion Independence
Time frame: Up to Month 24
Change from Baseline in European Quality of Life 5 Dimensions (EQ-5D-5L) Considered Minimally Clinical Important
Time frame: Up to Month 24
Change from Baseline in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ-C30) Considered Minimally Clinical Important
Time frame: Up to Month 24
Treatment Patterns Venetoclax in Combination with Hypomethylating Agents (HMAs) and in Switzerland in combination with Low Dose Cytarabine (LDAC)
Time frame: Up to Month 24
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 10 Dec 2025.
- Related Info.Link provided by the sponsor.
- Individual participant dataSharing planned: Undecided
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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
19 sites in 2 countries: 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 19 sites in 2 countries.
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 10 Dec 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 19 sites in Switzerland, Austria. 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 Month 24). 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 10 Dec 2025.