Evaluating the safety and effectiveness of venetoclax in patients with Acute Myeloid Leukemia
Prospective Non-interventional Study to Describe the Effectiveness and Safety of Venetoclax in Acute Myeloid Leukemia (AML) Patients in Routine Clinical Practice (REVIVE Study)
This study is testing how safe and effective the drug venetoclax is for people with Acute Myeloid Leukemia in everyday medical practice.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 100 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | AbbVie Industry-sponsored |
| Locations | 12 sites (Afula, H_efa and 11 other locations) |
| Trial ID | NCT03987958 on ClinicalTrials.gov |
What this trial studies
This observational study aims to assess the safety and effectiveness of venetoclax in patients diagnosed with Acute Myeloid Leukemia (AML) in routine clinical practice in Israel. The decision to initiate treatment with venetoclax is made by the physician prior to the patient's participation in the study. By observing real-world outcomes, the study seeks to provide insights into the drug's performance outside of controlled clinical trial settings.
Who should consider this trial
Good fit: Ideal candidates for this study are patients diagnosed with Acute Myeloid Leukemia who are eligible to receive venetoclax as determined by their physician.
Not a fit: Patients currently participating in an interventional trial or those not eligible for venetoclax treatment will not benefit from this study.
Why it matters
Potential benefit: If successful, this study could provide valuable information on the real-world effectiveness and safety of venetoclax for AML patients.
How similar studies have performed: While this study is observational, similar studies evaluating venetoclax have shown promising results in treating AML, indicating a potential for success.
Eligibility criteria
Show full inclusion / exclusion 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.
Where this trial is running
Afula, H_efa and 11 other locations
- HaEmek Medical Center /ID# 213370 — Afula, H_efa, Israel (Active_not_recruiting)
- Rambam Health Care Campus /ID# 213355 — Haifa, H_efa, Israel (Active_not_recruiting)
- Bnai Zion Medical Center /ID# 213344 — Haifa, H_efa, Israel (Active_not_recruiting)
- Soroka University Medical Center /ID# 213369 — Be'er Sheva, HaDarom, Israel (Active_not_recruiting)
- Meir Medical Center /ID# 213352 — Kfar Saba, HaMerkaz, Israel (Recruiting)
- Assuta Tel Aviv Medical Center /ID# 213371 — Tel Aviv, HaMerkaz, Israel (Active_not_recruiting)
- ZIV Medical Center /ID# 229211 — Safed, HaTsafon, Israel (Completed)
- The Chaim Sheba Medical Center /ID# 213353 — Ramat Gan, Tel-Aviv, Israel (Active_not_recruiting)
- Tel Aviv Sourasky Medical Center /ID# 213354 — Tel Aviv, Tel-Aviv, Israel (Active_not_recruiting)
- Shaare Zedek Medical Center /ID# 228016 — Jerusalem, Yerushalayim, Israel (Active_not_recruiting)
- Hadassah /ID# 213356 — Jerusalem, Yerushalayim, Israel (Active_not_recruiting)
- Rabin Medical Center /ID# 213343 — Haifa, Israel (Active_not_recruiting)
Study contacts
- Study coordinator: Jenia Berelovich
- Email: jenia.berelovich@abbvie.com
- Phone: 972528298196
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.