Clinical trial NCT03987958: A Study to Describe the Safety and Effectiveness of Venetoclax in Acute Myeloid Leukemia (AML) Patients (REVIVE Study)
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)
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Acute Myeloid Leukemia
Keywords: Acute Myeloid Leukemia, Venetoclax
Lead sponsor: AbbVie
Sponsor class: INDUSTRY
First posted: 2019-06-17
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Participants with AML treated with venetoclax in routine clinical practice

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.


Eligibility criteria: 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.

Primary outcomes:
measure: Overall Survival
timeFrame: Time from treatment to death from any cause, up to approximately 30 months
Secondary outcomes:
measure: Percentage of participants achieving composite complete remission (CR or CRi)
timeFrame: Approximately 30 months
measure: Time to transfusion independence
timeFrame: Up to 30 months
measure: Change in patient reported outcomes for the Euro Quality of Life 5 Dimensions 5 Levels Questionnaire (EQ-5D-5L)
timeFrame: Week 0 to approximately 30 months
measure: Percentage of participants treated with venetoclax as compared to participants treated with other approved biologics
timeFrame: Up to approximately 30 months
measure: Change in patient reported outcomes for the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire CORE (EORTC QLQ-C30)
timeFrame: Week 0 to approximately 30 months
measure: Percentage of participants achieving transfusion independence
timeFrame: Up to 30 months
Other outcomes:
Locations:
city: Afula
country: Israel
facility: HaEmek Medical Center /ID# 213370
state: H_efa
city: Haifa
country: Israel
facility: Rambam Health Care Campus /ID# 213355
state: H_efa
city: Haifa
country: Israel
facility: Bnai Zion Medical Center /ID# 213344
state: H_efa
city: Be'er Sheva
country: Israel
facility: Soroka University Medical Center /ID# 213369
state: HaDarom
city: Kfar Saba
country: Israel
facility: Meir Medical Center /ID# 213352
state: HaMerkaz
city: Tel Aviv
country: Israel
facility: Assuta Tel Aviv Medical Center /ID# 213371
state: HaMerkaz
city: Safed
country: Israel
facility: ZIV Medical Center /ID# 229211
state: HaTsafon
city: Ramat Gan
country: Israel
facility: The Chaim Sheba Medical Center /ID# 213353
state: Tel-Aviv
city: Tel Aviv
country: Israel
facility: Tel Aviv Sourasky Medical Center /ID# 213354
state: Tel-Aviv
city: Jerusalem
country: Israel
facility: Shaare Zedek Medical Center /ID# 228016
state: Yerushalayim
city: Jerusalem
country: Israel
facility: Hadassah /ID# 213356
state: Yerushalayim
city: Haifa
country: Israel
facility: Rabin Medical Center /ID# 213343
Study officials:
affiliation: AbbVie
name: ABBVIE INC.
role: STUDY_DIRECTOR
References: