BridgeMD
Double-Blind study comparing venetoclax and azacitidine versus placebo and azacitidine in patients that are newly diagnosed with Higher-Risk Myelodysplastic Syndrome
EU CTIS ID: 2023-507153-16-00
What this study is testing
To assess the efficacy of venetoclax in combination with azacitidine compared to placebo with azacitidine in treatment-naïve, higher-risk MDS population. The hypothesis corresponding to the primary objective is that venetoclax will improve the overall survival (OS) when added to standard of care azacitidine treatment in patients newly diagnosed with higher-risk MDS. The study has reached 100% overall survival (OS) events and completed planned final analysis.
- Therapeutic confirmatory (Phase III)
A plain-language read of the study's public EU CTIS listing. The study team confirms the details.
Who can take part
You may be able to join if
- Subjects must be ≥ 18 years of age with a diagnosis of MDS according to the 2016 World Health Organization (WHO) classification with presence of < 20% bone marrow blasts per marrow biopsy/aspirate at screening.
- Subjects must have no prior therapy for MDS with any hypomethylating agent, chemotherapy, or allogeneic stem cell transplantation, and must meet the following disease activity criteria: Overall Revised International Prognostic Scoring System (IPSS-R) score > 3 (intermediate, high, or very high); Eastern Cooperative Oncology Group (ECOG) performance status of ≤ 2; Hematopoietic stem cell transplant (HSCT) eligible with no pre-arranged HSCT at the time of Study Day 1 (not to exceed approximately 19% of subjects enrolled on study), or HSCT ineligible without plan for HSCT at the time of Study Day 1.
You likely can't join if
- For further information on the exclusion criteria, please refer to section 5.1 Eligibility Criteria of the Study Protocol
The study team makes the final eligibility decision.
Where it's taking place
- Korea, Republic of
- Russian Federation
- Taiwan
- Brazil
- Canada
- Turkey
- United States
- United Kingdom
- Japan
- China
- Puerto Rico
- Israel
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 65+ years, 18-64 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Korea, Republic of; Russian Federation; Taiwan; Brazil; Canada; Turkey and 6 more location(s). Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from EU CTIS; the study team decides eligibility.