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

January 15, 2024 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

Suspended

Conditions

Study Type

Observational

Enrollment (Estimated)

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 Locations

  • Israel
    • H_efa
      • Haifa, H_efa, Israel, 3109601
        • Rambam Health Care Campus /ID# 213355
      • Haifa, H_efa, Israel, 3339419
        • Bnai Zion Medical Center /ID# 213344
      • Haifa, H_efa, Israel, 4941492
        • Rabin Medical Center /ID# 213343
    • HaDarom
      • Afula, HaDarom, Israel, 1834111
        • HaEmek Medical Center /ID# 213370
      • Be'er Sheva, HaDarom, Israel, 8443901
        • Soroka University Medical Center /ID# 213369
    • HaMerkaz
      • Kfar Saba, HaMerkaz, Israel, 4428164
        • Meir Medical Center /ID# 213352
      • Tel Aviv, HaMerkaz, Israel, 6971028
        • Assuta Tel Aviv Medical Center /ID# 213371
    • HaTsafon
      • Safed, HaTsafon, Israel, 13100
        • ZIV Medical Center /ID# 229211
    • 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
    • Yerushalayim
      • Jerusalem, Yerushalayim, Israel, 91031
        • Shaare Zedek Medical Center /ID# 228016
      • Jerusalem, Yerushalayim, Israel, 91120
        • Hadassah /ID# 213356

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

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
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

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

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

AbbVie

Investigators

  • 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.

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)

August 8, 2019

Primary Completion (Estimated)

July 1, 2027

Study Completion (Estimated)

July 1, 2027

Study Registration Dates

First Submitted

June 14, 2019

First Submitted That Met QC Criteria

June 14, 2019

First Posted (Actual)

June 17, 2019

Study Record Updates

Last Update Posted (Actual)

January 17, 2024

Last Update Submitted That Met QC Criteria

January 15, 2024

Last Verified

January 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID 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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