A Study to Describe the Safety and Effectiveness of Venetoclax in Acute Myeloid Leukemia (AML) Patients (REVIVE Study) (REVIVE)
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|ClinicalTrials.gov Identifier: NCT03987958|
Recruitment Status : Recruiting
First Posted : June 17, 2019
Last Update Posted : August 29, 2019
|Condition or disease|
|Acute Myeloid Leukemia|
|Study Type :||Observational|
|Estimated Enrollment :||100 participants|
|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)|
|Actual Study Start Date :||August 12, 2019|
|Estimated Primary Completion Date :||July 1, 2023|
|Estimated Study Completion Date :||July 1, 2023|
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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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).
- 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.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03987958
|Contact: Hilla Banayan||+972 (0) 97 90 firstname.lastname@example.org|
|Bnai Zion Medical Center /ID# 213344||Recruiting|
|Haifa, Israel, 31000|
|Study Director:||AbbVie Inc.||AbbVie|