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出境医 / 临床实验 / A Study to Describe the Safety and Effectiveness of Venetoclax in Acute Myeloid Leukemia (AML) Patients (REVIVE Study) (REVIVE)
A Study to Describe the Safety and Effectiveness of Venetoclax in Acute Myeloid Leukemia (AML) Patients (REVIVE Study) (REVIVE)
Study Description
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 |
Study Design
| 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) |
| Actual Study Start Date : | August 8, 2019 |
| Estimated Primary Completion Date : | July 1, 2023 |
| Estimated Study Completion Date : | July 1, 2023 |
Arms and Interventions
| 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. |
Outcome Measures
Primary Outcome Measures :
- 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 :
- 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.
Eligibility Criteria
| 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.
Contacts and Locations
Contacts
| Contact: Hilla Banayan | +972 9 790 9655 | hilla.banayan@abbvie.com |
Locations
| Israel | |
| Soroka Medical Center /ID# 213369 | Recruiting |
| Be'er Sheva, HaDarom, Israel, 84101 | |
| Assuta Medical Centers /ID# 213371 | Recruiting |
| Tel Aviv, HaMerkaz, Israel, 6971028 | |
| Rabin Medical Center /ID# 213343 | Recruiting |
| Petah Tikva, Tel-Aviv, Israel, 4941492 | |
| Ha'Emek Medical Center /ID# 213370 | Recruiting |
| Afula, Israel, 18341 | |
| Rambam Health Care Campus /ID# 213355 | Recruiting |
| Haifa, Israel, 3109601 | |
| Bnai Zion Medical Center /ID# 213344 | Recruiting |
| Haifa, Israel, 3339419 | |
| Hadassah /ID# 213356 | Recruiting |
| Jerusalem, Israel, 91120 | |
| Meir Medical Center /ID# 213352 | Recruiting |
| Kfar Saba, Israel, 4428164 | |
| Sheba Medical Center /ID# 213353 | Recruiting |
| Ramat Gan, Israel, 5239424 | |
| Sourasky Medical Center /ID# 213354 | Recruiting |
| Tel-aviv, Israel, 62439 | |
Sponsors and Collaborators
AbbVie
Investigators
| Study Director: | AbbVie Inc. | AbbVie |
| Tracking Information | |||||||
|---|---|---|---|---|---|---|---|
| First Submitted Date | June 14, 2019 | ||||||
| First Posted Date | June 17, 2019 | ||||||
| Last Update Posted Date | December 9, 2020 | ||||||
| Actual Study Start Date | August 8, 2019 | ||||||
| Estimated Primary Completion Date | July 1, 2023 (Final data collection date for primary outcome measure) | ||||||
| Current Primary Outcome Measures |
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.
|
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| Original Primary Outcome Measures | Same as current | ||||||
| Change History | |||||||
| Current Secondary Outcome Measures |
|
||||||
| 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. |
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| Publications * | Not Provided | ||||||
|
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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| Recruitment Information | |||||||
| Recruitment Status | Recruiting | ||||||
| Estimated Enrollment |
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:
Exclusion Criteria:
|
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| Sex/Gender |
|
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| Ages | 18 Years and older (Adult, Older Adult) | ||||||
| Accepts Healthy Volunteers | No | ||||||
| Contacts |
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| 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 |
|
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| IPD Sharing Statement |
|
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| Responsible Party | AbbVie | ||||||
| Study Sponsor | AbbVie | ||||||
| Collaborators | Not Provided | ||||||
| Investigators |
|
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| PRS Account | AbbVie | ||||||
| Verification Date | December 2020 | ||||||
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