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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
Sponsor:
Information provided by (Responsible Party):
AbbVie

Tracking Information
First Submitted Date June 14, 2019
First Posted Date June 17, 2019
Last Update Posted Date August 29, 2019
Actual Study Start Date August 12, 2019
Estimated Primary Completion Date July 1, 2023   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: June 14, 2019)
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.
Original Primary Outcome Measures Same as current
Change History Complete list of historical versions of study NCT03987958 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures
 (submitted: June 14, 2019)
  • 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.
Original Secondary Outcome Measures Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title 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)
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 Provided
Study Type Observational
Study Design Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration Not Provided
Biospecimen Not Provided
Sampling Method Non-Probability Sample
Study Population Participants with AML treated with venetoclax in routine clinical practice
Condition Acute Myeloid Leukemia
Intervention Not Provided
Study Groups/Cohorts Venetoclax

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.

Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Recruiting
Estimated Enrollment
 (submitted: June 14, 2019)
100
Original Estimated Enrollment Same as current
Estimated Study Completion Date July 1, 2023
Estimated Primary Completion Date July 1, 2023   (Final data collection date for primary outcome measure)
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.
Sex/Gender
Sexes Eligible for Study: All
Ages 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers No
Contacts
Contact: Hilla Banayan +972 (0) 97 90 9655 hilla.banayan@abbvie.com
Listed Location Countries Israel
Removed Location Countries  
 
Administrative Information
NCT Number NCT03987958
Other Study ID Numbers P19-831
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: No
IPD Sharing Statement
Plan to Share IPD: Undecided
Responsible Party AbbVie
Study Sponsor AbbVie
Collaborators Not Provided
Investigators
Study Director: AbbVie Inc. AbbVie
PRS Account AbbVie
Verification Date August 2019