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Venetoclax + Azacitidine for Acute Myeloid Leukemia (VIALE-T Trial)
VIALE-T Trial Summary
This trial is testing if a combination of venetoclax and azacitidine can improve RFS in AML patients compared to BSC following allogeneic stem cell transplantation.
VIALE-T Trial Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowVIALE-T Trial Timeline
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Side effects data
From 2022 Phase 3 trial • 389 Patients • NCT02005471VIALE-T Trial Design
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Who is running the clinical trial?
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- I show signs of a blood cancer that has spread outside my bone marrow.My kidney, liver, and blood tests meet the study's requirements.I have AML and am planning or have had a stem cell transplant within 45 days.I am over 17 with a KPS score above 50, or 12-16 years old with a Lansky score above 40.I haven't had cancer, except for certain skin cancers or treated early-stage cancers, in the last 2 years.I have HIV or have had hepatitis B or C.My condition worsened while I was on venetoclax.I am at least 18 years old for Part 1 or at least 12 years old for Part 2.
- Group 1: Part 1: Venetoclax + Azacitidine (AZA) + Best Supportive Care
- Group 2: Part 2: Arm A - Venetoclax + Azacitidine (AZA) + BSC
- Group 3: Part 2: Arm B - Best Supportive Care (BSC)
- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
- Pivotal Trial - The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.
- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
Are there any available slots for participants in this clinical trial?
"According to the latest information on clinicaltrials.gov, this trial is still recruiting patients. The first posting was on February 26th, 2020 and the page was last updated on October 31st, 2020."
What are the most popular medical applications for Venetoclax?
"Venetoclax is often used to treat induction chemotherapy, as well as other blood disorders such as refractory anemias, leukemia, myelocytic, acute, and multilineage dysplasia."
Could you please tell us what the side effects of Venetoclax are?
"Venetoclax has received a safety score of 3. This is because it has reached Phase 3 in clinical trials, meaning that there is both evidence of efficacy and multiple rounds of data supporting safety."
What are the primary goals of this experiment?
"The primary objective for this clinical trial, which will follow participants for up to 39 months after enrolling the first person, is to assess the number of people who experience dose-limiting toxicities after receiving venetoclax and azacitidine. Additionally, the study will track secondary outcomes including GvHD-free and relapse-free survival rates, GvHD rate, and time to deterioration in global health status or quality of life."
How many sites are participating in this clinical trial?
"This clinical trial has 60 enrollees at locations such as Montreal General Hospital - McGill University Health Center /ID# 215253 in Montreal, Weill Cornell Medical College /ID# 214887 in New york, and Saskatoon Cancer Centre /ID# 238821 in Saskatoon. There are also 60 other locations where patients are participating."
What other Venetoclax studies have taken place?
"350 clinical trials worldwide are currently underway to study Venetoclax. Of those, 55 are Phase 3 trials. The majority of these trials are based in Edmonton, Alberta, but there are 11235 locations running studies for this treatment."
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