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Nucleoside Metabolic Inhibitor

Tamibarotene + Venetoclax/Azacitidine for Acute Myeloid Leukemia

Phase 2
Recruiting
Research Sponsored by Syros Pharmaceuticals
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
All participants must have obtained a blood sample for RARA biomarker investigational assay testing prior to starting treatment on Cycle 1 Day 1. The results of the investigational biomarker assay for all participants must be confirmed as RARA-positive by Cycle 1 Day 8 to enroll (Part 1) or to be randomized (Part 2) in the study.
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 3 years
Awards & highlights

Study Summary

This trial will test whether adding tamibarotene to the 2 other drugs helps people with this specific type of leukemia live longer.

Who is the study for?
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.Check my eligibility
What is being tested?
The study tests Tamibarotene combined with Venetoclax and Azacitidine in patients with acute myeloid leukemia (AML). It targets those whose cancer has the RARA gene overexpression and are unsuitable for standard chemotherapy.See study design
What are the potential side effects?
Potential side effects may include typical reactions to cancer drugs such as nausea, fatigue, blood cell count changes leading to increased infection risk, liver function alterations, and possible bleeding complications.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
Select...
My blood test before treatment showed I am RARA-positive.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 3 years
This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 3 years for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Part 1: Number of Participants With Adverse Events
Part 2: CR/CRi Rate
Secondary outcome measures
Part 1: Overall Response Rate (ORR)
Plasma Exchange
Part 2: CR Rate
+9 more

Trial Design

4Treatment groups
Experimental Treatment
Active Control
Group I: Part 3: Tamibarotene/Venetoclax/AzacitidineExperimental Treatment3 Interventions
Part 2 participants treated with venetoclax/azacitidine who experience progressive disease, relapse after initial CR or CRi response, or treatment failure may begin subsequent treatment in Part 3, where tamibarotene will be added to their regimen.
Group II: Part 2: Tamibarotene/Venetoclax/AzacitidineExperimental Treatment3 Interventions
Participants will receive the tamibarotene/venetoclax/azacitidine triplet combination at the dose and regimen selected in Part 1.
Group III: Part 1: Tamibarotene/Venetoclax/AzacitidineExperimental Treatment3 Interventions
Participants will receive the tamibarotene/venetoclax/azacitidine triplet combination as follows: Azacitidine (intravenously or subcutaneously) at 75 milligrams (mg)/square meter (m^2) once daily, on Days 1 through 7 of each 28-day therapy cycle (per VIDAZA USPI). Alternative dosing of azacitidine (Days 1 through 5, 8, and 9) will be permitted throughout the study. Venetoclax (orally) daily on Days 1 through 28 per standard of care. Standard of care daily dosing is 100 mg on Day 1, 200 mg on Day 2, and 400 mg on Day 3 and beyond. Tamibarotene 6 mg twice daily (BID) orally, on Days 8 through 28 of each 28-day therapy cycle. Tamibarotene will only be administered to participants who have been confirmed as RARA-positive.
Group IV: Part 2: Venetoclax/AzacitidineActive Control2 Interventions
Participants will receive the venetoclax/azacitidine combination at the dose and regimen selected in Part 1.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Tamibarotene
Not yet FDA approved
Venetoclax
2019
Completed Phase 3
~1990
Azacitidine
2012
Completed Phase 3
~1440

Find a Location

Who is running the clinical trial?

Syros PharmaceuticalsLead Sponsor
5 Previous Clinical Trials
933 Total Patients Enrolled
Medical Director, MDStudy DirectorSyros Pharmaceuticals
77 Previous Clinical Trials
16,321 Total Patients Enrolled
Michael Kelly Executive Medical Director, MDStudy DirectorSyros Pharmaceuticals

Media Library

Azacitidine (Nucleoside Metabolic Inhibitor) Clinical Trial Eligibility Overview. Trial Name: NCT04905407 — Phase 2
Acute Myeloid Leukemia Research Study Groups: Part 3: Tamibarotene/Venetoclax/Azacitidine, Part 2: Venetoclax/Azacitidine, Part 1: Tamibarotene/Venetoclax/Azacitidine, Part 2: Tamibarotene/Venetoclax/Azacitidine
Acute Myeloid Leukemia Clinical Trial 2023: Azacitidine Highlights & Side Effects. Trial Name: NCT04905407 — Phase 2
Azacitidine (Nucleoside Metabolic Inhibitor) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04905407 — Phase 2

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Could you provide examples of other research initiatives involving SY-1425?

"SY-1425 was first investigated by the Chinese University of Hong Kong-Prince of Wales Hospital in 2006. Since then, 209 investigations have been concluded and 340 additional trials are presently enrolling participants; a great number of these clinical tests take place in Kansas City, Missouri."

Answered by AI

Are there hazardous outcomes to using SY-1425?

"Power assessed SY-1425's risk level as a 2, since this Phase 2 trial has provided evidence of safety but not yet addressed efficacy."

Answered by AI

Are there any American health facilities facilitating this clinical investigation?

"This clinical trial is accepting new participants at HCA Midwest Research Medical Center in Kansas City, Missouri, MD Anderson Cancer Centre in Houston, Texas and University of Colorado in Denver, Colorado alongside 8 additional medical centres."

Answered by AI

What therapeutic purposes does SY-1425 typically serve?

"SY-1425 has the potential to manage induction chemotherapy, refractory anemias, and acute myelocytic leukemia."

Answered by AI

Is this medical study currently enrolling patients?

"The trial is currently recruiting, as cited on clinicaltrials.gov. It was initially announced to the public on August 26th 2021 and has since been amended on November 9th 2022."

Answered by AI

How many participants have been recruited for this clinical research?

"To conduct the trial successfully, 95 qualified participants need to be recruited. Syros Pharmaceuticals will coordinate the investigation through multiple sites, such as HCA Midwest Research Medical Center in Kansas City and MD Anderson Cancer Centre in Houston."

Answered by AI
Recent research and studies
clinicaltrials.govStudy
Tamibarotene Plus Venetoclax/Azacitidine in Participants With Newly Diagnosed AML
2021. "Tamibarotene Plus Venetoclax/Azacitidine in Participants With Newly Diagnosed AML". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04905407.
~57 spots leftby Apr 2028
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