A Study to Describe the Safety and Effectiveness of Venetoclax in Acute Myeloid Leukemia (AML) Patients (REVIVE Study)
- Conditions
- Acute Myeloid Leukemia
- Registration Number
- NCT03987958
- Lead Sponsor
- AbbVie
- Brief 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 100
- 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.
- Participant participating in an interventional trial within 30 days prior to starting venetoclax treatment.
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Overall Survival 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 Outcome Measures
Name Time Method Change in patient reported outcomes for the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire CORE (EORTC QLQ-C30) 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 composite complete remission (CR or CRi) 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.
Change in patient reported outcomes for the Euro Quality of Life 5 Dimensions 5 Levels Questionnaire (EQ-5D-5L) 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 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.
Time to transfusion independence 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.
Percentage of participants achieving transfusion independence 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.
Trial Locations
- Locations (12)
HaEmek Medical Center /ID# 213370
🇮🇱Afula, H_efa, Israel
Rambam Health Care Campus /ID# 213355
🇮🇱Haifa, H_efa, Israel
Bnai Zion Medical Center /ID# 213344
🇮🇱Haifa, H_efa, Israel
Soroka University Medical Center /ID# 213369
🇮🇱Be'er Sheva, HaDarom, Israel
Meir Medical Center /ID# 213352
🇮🇱Kfar Saba, HaMerkaz, Israel
Assuta Tel Aviv Medical Center /ID# 213371
🇮🇱Tel Aviv, HaMerkaz, Israel
ZIV Medical Center /ID# 229211
🇮🇱Safed, HaTsafon, Israel
The Chaim Sheba Medical Center /ID# 213353
🇮🇱Ramat Gan, Tel-Aviv, Israel
Tel Aviv Sourasky Medical Center /ID# 213354
🇮🇱Tel Aviv, Tel-Aviv, Israel
Shaare Zedek Medical Center /ID# 228016
🇮🇱Jerusalem, Yerushalayim, Israel
Hadassah /ID# 213356
🇮🇱Jerusalem, Yerushalayim, Israel
Rabin Medical Center /ID# 213343
🇮🇱Haifa, Israel