Tamibarotene Plus Venetoclax/Azacitidine in Participants With Newly Diagnosed AML

  • STATUS
    Recruiting
  • End date
    Dec 21, 2023
  • participants needed
    95
  • sponsor
    Syros Pharmaceuticals
Updated on 21 April 2022
cancer
carbon monoxide
ejection fraction
azacitidine
acute promyelocytic leukemia
blast cells
venetoclax

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 IdentifierNCT04905407
SponsorSyros Pharmaceuticals
Last Modified on21 April 2022

Eligibility

Yes No Not Sure

Inclusion Criteria

Participants must be RARA-positive based on the investigational assay
Participants must have newly diagnosed, previously untreated non-acute promyelocytic leukemia (APL) AML with a bone marrow or peripheral blood blast count ≥20% and must be unlikely to tolerate standard intensive chemotherapy at the time of study entry due to age, performance status, or comorbidities based on at least one of the following
criteria
age ≥75 years old, or
age <75 years old, with at least one of the following
Eastern Cooperative Oncology Group (ECOG) performance status of 3
cardiac history of congestive heart failure (CHF) or documented ejection fraction (EF) ≤50%
pulmonary disease with diffusing capacity of the lungs for carbon monoxide (DLCO) ≤65% or forced expiratory volume in one second (FEV1) ≤65%
creatinine clearance ≥30 milliliters (mL)/minute (min) to <45 mL/min based on the Cockcroft-Gault glomerular filtration rate estimation
hepatic impairment with total bilirubin >1.5 to ≤3.0 upper limit of normal (ULN)
any other comorbidity that the investigator judges to be incompatible with intensive chemotherapy, and reviewed and approved by the sponsor prior to enrollment

Exclusion Criteria

Participants have APL
Participants have known active central nervous system involvement with AML
Prior treatment for the diagnosis of AML, myelodysplastic syndromes (MDS), or antecedent hematologic malignancy with any hypomethylating agent, venetoclax, chemotherapy, or hematopoietic stem cell transplantation (HSCT), with the exception of prior treatment with hydroxyurea
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