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

Acute Myeloid Leukemia Clinical Trial

— REVIVE  

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)

Clinical Trial Details — Status: Suspended

Administrative data

• NCT number: NCT03987958
• Other study ID #: P19-831
• Status: Suspended
• Start date: August 8, 2019
• Est. completion date: July 1, 2027

Study information

• Verified date: January 2024
• Source: AbbVie
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Suspended
• Enrollment: 100
• Est. completion date: July 1, 2027
• Est. primary completion date: July 1, 2027
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Acute Myeloid Leukemia
• Leukemia
• Leukemia, Myeloid
• Leukemia, Myeloid, Acute

Locations

Country	Name	City	State
Israel	HaEmek Medical Center /ID# 213370	Afula	HaDarom
Israel	Soroka University Medical Center /ID# 213369	Be'er Sheva	HaDarom
Israel	Bnai Zion Medical Center /ID# 213344	Haifa	H_efa
Israel	Rabin Medical Center /ID# 213343	Haifa	H_efa
Israel	Rambam Health Care Campus /ID# 213355	Haifa	H_efa
Israel	Hadassah /ID# 213356	Jerusalem	Yerushalayim
Israel	Shaare Zedek Medical Center /ID# 228016	Jerusalem	Yerushalayim
Israel	Meir Medical Center /ID# 213352	Kfar Saba	HaMerkaz
Israel	The Chaim Sheba Medical Center /ID# 213353	Ramat Gan	Tel-Aviv
Israel	ZIV Medical Center /ID# 229211	Safed	HaTsafon
Israel	Assuta Tel Aviv Medical Center /ID# 213371	Tel Aviv	HaMerkaz
Israel	Tel Aviv Sourasky Medical Center /ID# 213354	Tel Aviv	Tel-Aviv

Sponsors (1)

Lead Sponsor	Collaborator
AbbVie

Country where clinical trial is conducted

Israel, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Overall Survival	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	Percentage of participants achieving composite complete remission (CR or CRi)	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
Secondary	Time to transfusion independence	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
Secondary	Change in patient reported outcomes for the Euro Quality of Life 5 Dimensions 5 Levels Questionnaire (EQ-5D-5L)	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
Secondary	Percentage of participants treated with venetoclax as compared to participants treated with other approved biologics	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
Secondary	Change in patient reported outcomes for the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire CORE (EORTC QLQ-C30)	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
Secondary	Percentage of participants achieving transfusion independence	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

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