Acute Myeloid LeukemiaREVIVENCT03987958
A Study to Describe the Safety and Effectiveness of Venetoclax in Acute Myeloid Leukemia (AML) Patients (REVIVE Study)
An observational study of Acute Myeloid Leukemia, run by AbbVie at 12 sites in Israel.
Trial summary
This study will describe the safety and effectiveness of venetoclax in AML patients in routine clinical practice in Israel. The decision to treat with venetoclax is made by the physician prior to any decision regarding participation in this study. 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
- 100 participants
- Where
- 12 sitesIsrael
- Study dates
- 8 Aug 2019to Jul 2027
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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: Participants with AML treated with venetoclax in routine clinical practice
Who may be able to join
- Participant diagnosed with Acute Myeloid Leukemia (AML) and is eligible to receive venetoclax per Israel Ministry of Health.
- Participant who will be treated with venetoclax and the decision to treat with venetoclax is made by the physician prior to any decision regarding participation in this study.
Who cannot join
- Participant participating in an interventional trial within 30 days prior to starting venetoclax treatment.
Trial locations and contacts
12 sites in 1 country.
12 sites in 1 country
Israel12 sites
HaEmek Medical Center /ID# 213370
Afula, Haifa District, 1834111
Soroka University Medical Center /ID# 213369
Beersheba, Southern District, 8443901
Rambam Health Care Campus /ID# 213355
Haifa, 3109601
Bnai Zion Medical Center /ID# 213344
Haifa, 3339419
Shaare Zedek Medical Center /ID# 228016
Jerusalem, Jerusalem, 91031
Hadassah /ID# 213356
Jerusalem, Jerusalem, 91120
Meir Medical Center /ID# 213352
Kfar Saba, Central District, 4428164
Rabin Medical Center. /ID# 213343
Petah Tikva, 4941492
The Chaim Sheba Medical Center /ID# 213353
Ramat Gan, Tel Aviv, 5265601
ZIV Medical Center /ID# 229211
Safed, Northern District, 13100
Assuta Tel Aviv Medical Center /ID# 213371
Tel Aviv, Central District, 6971028
Tel Aviv Sourasky Medical Center /ID# 213354
Tel Aviv, Tel Aviv, 6423906
About this study
Official title: Prospective Non-interventional Study to Describe the Effectiveness and Safety of Venetoclax in Acute Myeloid Leukemia (AML) Patients in Routine Clinical Practice (REVIVE Study)
This study will describe the safety and effectiveness of venetoclax in AML patients in routine clinical practice in Israel. The decision to treat with venetoclax is made by the physician prior to any decision regarding participation in this study.
- Conditions
- Acute Myeloid Leukemia
- Keywords
- Acute Myeloid Leukemia, Venetoclax
- Medical subject headings
- Leukemia, Myeloid, Acute
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 in this observational study will receive treatment with venetoclax for AML. The decision to treat with venetoclax has been made independently from this observational study before participants are offered the opportunity to participate in this study. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Overall Survival
Overall survival is defined as the time from the date of first treatment to the date of death from any cause.
Measured: Time from treatment to death from any cause, up to approximately 30 months
Secondary outcomes (6)
Percentage of participants achieving composite complete remission (CR or CRi)
The percentage of participants achieving CR or CRi will be calculated based on the modified International Working Group (IWG) criteria for AML.
Measured: Approximately 30 months
Time to transfusion independence
Transfusion independence is defined as the time between date of first venetoclax treatment and absence of red blood cell (RBC) or platelet transfusion for any consecutive 8 and/or 16 week period.
Measured: Up to 30 months
Percentage of participants achieving transfusion independence
Transfusion independence is defined as the time between date of first venetoclax treatment and absence of red blood cell (RBC) or platelet transfusion for any consecutive 8 and/or 16 week period.
Measured: Up to 30 months
Percentage of participants treated with venetoclax as compared to participants treated with other approved biologics
The percentage of participants treated with venetoclax in combination with Hypomethylating Agents (HMAs) and Low Dose Cytarabine (LDAC) will demonstrate treatment patterns of prescribing physicians.
Measured: Up to approximately 30 months
Change in patient reported outcomes for the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire CORE (EORTC QLQ-C30)
EORTC QLQ-C30 is a 30-item subject self-report questionnaire composed of both multi-item and single scales, including global health status/quality of life, functional scales (physical, role, emotional, cognitive, and social), symptom scales (fatigue, nausea and vomiting, and pain), and 6 single items (dyspnea, insomnia, appetite loss, constipation, diarrhea, and financial difficulties).
Measured: Week 0 to approximately 30 months
Change in patient reported outcomes for the Euro Quality of Life 5 Dimensions 5 Levels Questionnaire (EQ-5D-5L)
The EQ-5D-5L is a standardized, non-disease specific instrument used to measure health-related quality of life. The EQ-5D-5L assesses general health on 5 dimensions (mobility, self-care, usual activities, pain/discomfort and anxiety/depression). Each dimension has 5 levels (no problems, slight problems, moderate problems, severe problems, and extreme problems). The scores for the 5 dimensions are used to compute a single utility index score ranging from 0 to 1 representing the general health status of the individual, with higher scores indicating better health state.
Measured: Week 0 to approximately 30 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Jun 2019
- Study start8 Aug 2019
- Primary completionJul 2027 (estimated)
- Study completionJul 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- 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
- 100 participants (estimated)
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
- NCT03987958
- Sponsor's protocol ID
- P19-831
- Acronym
- REVIVE
- Status last verified
- Jan 2026
- First submitted
- 14 Jun 2019
- Last updated
- 16 Jan 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Wolach O, Levi I, Nachmias B, Tavor S, Amitai I, Ofran Y, Ganzel C, Zuckerman T, Okasha D, Hellmann I, Tadmor T, Dally N, Canaani J, Stemer G, Grunspan M, Berger AJ, Frankel N, Berelovich J, Bleterman A, Barak M, Cohen R, Moshe Y. Trial eligibility, treatment patterns, and outcome for venetoclax-based therapy in AML: a prospective cohort study. Blood Adv. 2025 Apr 8;9(7):1544-1554. doi: 10.1182/bloodadvances.2024014014.
PubMed 39637307
Study at a glance
From the registry record, last updated by the sponsor on 16 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prospective Non-interventional Study to Describe the Effectiveness and Safety of Venetoclax in Acute Myeloid Leukemia (AML) Patients in Routine Clinical Practice (REVIVE Study)
- ClinicalTrials.gov ID
- NCT03987958
- Acronym / sponsor ID
- REVIVE / P19-831
- Conditions
- Acute Myeloid Leukemia
- Keywords
- Acute Myeloid Leukemia, Venetoclax
- Study type
- Observational
- Recruitment status
- Active, not recruiting
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- AbbVieIndustry (pharma, biotech, devices)
- Study start
- 8 Aug 2019 (actual)
- Primary completion
- Jul 2027 (estimated)
- Study completion
- Jul 2027 (estimated)
- First posted
- 17 Jun 2019 (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.
This study will describe the safety and effectiveness of venetoclax in AML patients in routine clinical practice in Israel. The decision to treat with venetoclax is made by the physician prior to any decision regarding participation in this study.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Venetoclax | – | –Participants in this observational study will receive treatment with venetoclax for AML. The decision to treat with venetoclax has been made independently from this observational study before participants are offered the opportunity to participate in this study. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Participants with AML treated with venetoclax in routine clinical practice
Key inclusion criteria (2 listed)
- Participant diagnosed with Acute Myeloid Leukemia (AML) and is eligible to receive venetoclax per Israel Ministry of Health.
- Participant who will be treated with venetoclax and the decision to treat with venetoclax is made by the physician prior to any decision regarding participation in this study.
Key exclusion criteria (1 listed)
- Participant participating in an interventional trial within 30 days prior to starting venetoclax treatment.
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
Overall Survival
Time frame: Time from treatment to death from any cause, up to approximately 30 months
Overall survival is defined as the time from the date of first treatment to the date of death from any cause.
6 secondary outcomes
Percentage of participants achieving composite complete remission (CR or CRi)
Time frame: Approximately 30 months
Time to transfusion independence
Time frame: Up to 30 months
Percentage of participants achieving transfusion independence
Time frame: Up to 30 months
Percentage of participants treated with venetoclax as compared to participants treated with other approved biologics
Time frame: Up to approximately 30 months
Change in patient reported outcomes for the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire CORE (EORTC QLQ-C30)
Time frame: Week 0 to approximately 30 months
Change in patient reported outcomes for the Euro Quality of Life 5 Dimensions 5 Levels Questionnaire (EQ-5D-5L)
Time frame: Week 0 to approximately 30 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Jan 2026.
- Derived from this study: PubMed 39637307Wolach O, Levi I, Nachmias B, Tavor S, Amitai I, Ofran Y, Ganzel C, Zuckerman T, Okasha D, Hellmann I, Tadmor T, Dally N, Canaani J, Stemer G, Grunspan M, Berger AJ, Frankel N, Berelovich J, Bleterman A, Barak M, Cohen R, Moshe Y. Trial eligibility, treatment patterns, and outcome for venetoclax-based therapy in AML: a prospective cohort study. Blood Adv. 2025 Apr 8;9(7):1544-1554. doi: 10.1182/bloodadvances.2024014014.
- Related infoLink 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
12 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 12 sites in Israel.
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: under way, not looking for participants, as of the sponsor's last update on 16 Jan 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 12 sites in Israel. 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?
This study is still under way. Results are not available in the source record yet.
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?
Overall Survival (time frame: Time from treatment to death from any cause, up to approximately 30 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03987958, which also lists 1 linked publication.
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 16 Jan 2026.