Tamibarotene + Venetoclax/Azacitidine for Acute Myeloid Leukemia
What You Need to Know Before You Apply
What is the purpose of this trial?
Tamibarotene is being studied as a treatment for participants with a type of leukemia called acute myeloid leukemia, or AML for short. Tamibarotene is being studied as a treatment for participants with AML whose cancer has a specific genetic abnormality characterized by the overexpression of the retinoic acid receptor alpha (RARA) gene. This genetic profile is found in about 3 of every 10 people with AML.During the trial, tamibarotene will be given with 2 other drugs that are already used together to treat people who have AML and who cannot start treatment with standard chemotherapy.
Who Is on the Research Team?
Michael Kelly Executive Medical Director, MD
Principal Investigator
Syros Pharmaceuticals
Are You a Good Fit for This Trial?
This trial is for adults with newly diagnosed AML who can't start standard chemo due to age, health, or other issues. They must have a certain gene abnormality (RARA-positive) and not have had previous treatments for their leukemia except hydroxyurea.Inclusion Criteria
Exclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Part 1: Safety and Dose Evaluation
Evaluation of safety, tolerability, and pharmacokinetics of tamibarotene/venetoclax/azacitidine combination to determine appropriate dosing
Part 2: Randomized Treatment
Participants are randomized to receive either tamibarotene/venetoclax/azacitidine or venetoclax/azacitidine to compare clinical activity
Part 3: Treatment for Progressive Disease
Tamibarotene is added to the regimen for participants experiencing progressive disease, relapse, or treatment failure
Follow-up
Participants are monitored for safety and effectiveness after treatment
What Are the Treatments Tested in This Trial?
Interventions
- Azacitidine
- Tamibarotene
- Venetoclax
Azacitidine is already approved in European Union, United States, Canada, Japan for the following indications:
Find a Clinic Near You
Who Is Running the Clinical Trial?
Syros Pharmaceuticals
Lead Sponsor