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Active, not recruiting

NCT Number: NCT03987958

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

Active, not recruiting

This study is active but is not currently recruiting participants.

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Key information

Conditions

Acute Myeloid Leukemia Hematologic Diseases Hemic and Lymphatic Diseases Leukemia Leukemia, Myeloid Leukemia, Myeloid, Acute Neoplasms Neoplasms by Histologic Type

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Meir Medical Center /ID# 213352, Kfar Saba, Central District, Israel

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Primary outcomes

  1. 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.

Secondary outcomes

  1. 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.

  2. 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.

  3. 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.

  4. 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.

  5. 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).

  6. 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.

Sponsors and collaborators

Lead sponsor

AbbVie

Industry

Registry information

Official study 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)

Acronym: REVIVE

Important dates

Study start
2019
Primary completion
2027
Study completion
2027
First posted
Jun 17, 2019
Registry last updated
Jan 16, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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