A Study to Describe the Safety and Effectiveness of Venetoclax in Acute Myeloid Leukemia (AML) Patients (REVIVE Study) (REVIVE)

January 15, 2026 updated by: AbbVie

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Active, not recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
100

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Locations

  • Israel
      • Haifa, Israel, 3109601
        • Rambam Health Care Campus /ID# 213355
      • Haifa, Israel, 3339419
        • Bnai Zion Medical Center /ID# 213344
      • Petah Tikva, Israel, 4941492
        • Rabin Medical Center. /ID# 213343
    • Central District
      • Kfar Saba, Central District, Israel, 4428164
        • Meir Medical Center /ID# 213352
      • Tel Aviv, Central District, Israel, 6971028
        • Assuta Tel Aviv Medical Center /ID# 213371
    • Haifa District
      • Afula, Haifa District, Israel, 1834111
        • HaEmek Medical Center /ID# 213370
    • Jerusalem
      • Jerusalem, Jerusalem, Israel, 91031
        • Shaare Zedek Medical Center /ID# 228016
      • Jerusalem, Jerusalem, Israel, 91120
        • Hadassah /ID# 213356
    • Northern District
      • Safed, Northern District, Israel, 13100
        • ZIV Medical Center /ID# 229211
    • Southern District
      • Beersheba, Southern District, Israel, 8443901
        • Soroka University Medical Center /ID# 213369
    • Tel Aviv
      • Ramat Gan, Tel Aviv, Israel, 5265601
        • The Chaim Sheba Medical Center /ID# 213353
      • Tel Aviv, Tel Aviv, Israel, 6423906
        • Tel Aviv Sourasky Medical Center /ID# 213354

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

Participants with AML treated with venetoclax in routine clinical practice

Description

Inclusion Criteria:

  • 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.

Exclusion Criteria:

- Participant participating in an interventional trial within 30 days prior to starting venetoclax treatment.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort

Group / Cohort

A group or subgroup of participants in an observational study that is assessed for biomedical or health outcomes.
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 the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
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.
Time from treatment to death from any cause, up to approximately 30 months

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Percentage of participants achieving composite complete remission (CR or CRi)
Time Frame: Approximately 30 months
The percentage of participants achieving CR or CRi will be calculated based on the modified International Working Group (IWG) criteria for AML.
Approximately 30 months
Time to transfusion independence
Time Frame: Up to 30 months
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.
Up to 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
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.
Week 0 to approximately 30 months
Percentage of participants treated with venetoclax as compared to participants treated with other approved biologics
Time Frame: Up to approximately 30 months
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.
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
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).
Week 0 to approximately 30 months
Percentage of participants achieving transfusion independence
Time Frame: Up to 30 months
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.
Up to 30 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
AbbVie

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Study Director: ABBVIE INC., AbbVie

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
August 8, 2019

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
July 1, 2027

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
July 1, 2027

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
June 14, 2019

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
June 14, 2019

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
June 17, 2019

Study Record Updates

Last Update Posted (Estimated)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
January 16, 2026

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
January 15, 2026

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
January 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • P19-831

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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