Tamibarotene Plus Venetoclax/Azacitidine in Participants With Newly Diagnosed AML
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- STATUS
- Recruiting
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- End date
- Dec 21, 2023
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- participants needed
- 95
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- sponsor
- Syros Pharmaceuticals
Summary
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.
Description
This study consists of 3 parts. In Part 1, the safety, tolerability, and pharmacokinetic (PK) evaluation of tamibarotene/venetoclax/azacitidine combination will inform the appropriate triplet dose and regimen for Part 2. In Part 2, participants will be randomized 1:1 to receive either tamibarotene/venetoclax/azacitidine or venetoclax/azacitidine to explore comparative clinical activity of the 2 combinations. In Part 3, tamibarotene will be added to the venetoclax/azacytidine regimen of a subset of Part 2 participants who experience progressive disease, relapse after initial complete remission (CR) or CR with incomplete blood count recovery (CRi) response, or treatment failure.
Details
| Condition | Acute Myeloid Leukemia |
|---|---|
| Treatment | Azacitidine, venetoclax, SY-1425, Tamibarotene |
| Clinical Study Identifier | NCT04905407 |
| Sponsor | Syros Pharmaceuticals |
| Last Modified on | 21 April 2022 |
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