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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 : Not yet recruiting
First Posted : June 17, 2019
Last Update Posted : June 17, 2019
Sponsor:
Information provided by (Responsible Party):
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.

Condition or disease
Acute Myeloid Leukemia

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Study Type : Observational
Estimated Enrollment : 100 participants
Observational Model: Cohort
Time Perspective: Prospective
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)
Estimated Study Start Date : July 1, 2019
Estimated Primary Completion Date : July 1, 2023
Estimated Study Completion Date : July 1, 2023


Group/Cohort
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.




Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. 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.

  2. 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.

  3. 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.

  4. 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.

  5. 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).

  6. 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.



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Participants with AML treated with venetoclax in routine clinical practice
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.


Information from the National Library of Medicine

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


Contacts
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Contact: Hilla Banayan +972 9 790 9655 hilla.banayan@abbvie.com

Sponsors and Collaborators
AbbVie
Investigators
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Study Director: AbbVie Inc. AbbVie

Additional Information:
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Responsible Party: AbbVie
ClinicalTrials.gov Identifier: NCT03987958     History of Changes
Other Study ID Numbers: P19-831
First Posted: June 17, 2019    Key Record Dates
Last Update Posted: June 17, 2019
Last Verified: June 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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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

Keywords provided by AbbVie:
Acute Myeloid Leukemia
Venetoclax

Additional relevant MeSH terms:
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Leukemia
Leukemia, Myeloid
Leukemia, Myeloid, Acute
Neoplasms by Histologic Type
Neoplasms
Venetoclax
Antineoplastic Agents