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Tamibarotene Plus Venetoclax/Azacitidine in Participants With Newly Diagnosed Acute Myeloid Leukemia (AML)

NCT04905407 · Status: TERMINATED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 66

Last updated 2025-02-24

Study results available
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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.

Conditions

Interventions

DRUG

Tamibarotene

Tamibarotene tablets will be administered per dose and schedule specified in the arm.

DRUG

Venetoclax

Venetoclax tablets will be administered per dose and schedule specified in the arm.

DRUG

Azacitidine

Azacitidine injection will be administered per dose and schedule specified in the arm.

Sponsors & Collaborators

  • Syros Pharmaceuticals

    lead INDUSTRY

Principal Investigators

  • Michael Kelly Executive Medical Director, MD · Syros Pharmaceuticals

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2021-08-26
Primary Completion
2024-08-12
Completion
2024-08-12
FDA Drug
Yes

Countries

  • United States
  • France

Study Locations

More Related Trials

Entities

Drugs
Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04905407 on ClinicalTrials.gov