66 Participants Needed

Tamibarotene + Venetoclax/Azacitidine for Acute Myeloid Leukemia

Recruiting at 30 trial locations
MD
CT
KC
EW
GC
Overseen ByGalina Craig
Age: 18+
Sex: Any
Trial Phase: Phase 2
Sponsor: Syros Pharmaceuticals
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)
Prior Safety DataThis treatment has passed at least one previous human trial

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?

MK

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

I have a new AML diagnosis, haven't been treated, and can't handle strong chemotherapy.
My blood test before treatment showed I am RARA-positive.

Exclusion Criteria

I have not had specific treatments for AML, MDS, or other blood cancers before starting this trial, except for hydroxyurea.
I have acute promyelocytic leukemia (APL).
My acute myeloid leukemia has spread to my brain or spinal cord.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Part 1: Safety and Dose Evaluation

Evaluation of safety, tolerability, and pharmacokinetics of tamibarotene/venetoclax/azacitidine combination to determine appropriate dosing

28 days per cycle
Multiple visits per cycle

Part 2: Randomized Treatment

Participants are randomized to receive either tamibarotene/venetoclax/azacitidine or venetoclax/azacitidine to compare clinical activity

28 days per cycle, up to 3 years
Multiple visits per cycle

Part 3: Treatment for Progressive Disease

Tamibarotene is added to the regimen for participants experiencing progressive disease, relapse, or treatment failure

28 days per cycle, up to 3 years
Multiple visits per cycle

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

  • Azacitidine
  • Tamibarotene
  • Venetoclax
Trial Overview 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.
How Is the Trial Designed?
4Treatment groups
Experimental Treatment
Active Control
Group I: Part 3: Tamibarotene/Venetoclax/AzacitidineExperimental Treatment3 Interventions
Group II: Part 2: Tamibarotene/Venetoclax/AzacitidineExperimental Treatment3 Interventions
Group III: Part 1: Tamibarotene/Venetoclax/AzacitidineExperimental Treatment3 Interventions
Group IV: Part 2: Venetoclax/AzacitidineActive Control2 Interventions

Azacitidine is already approved in European Union, United States, Canada, Japan for the following indications:

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Approved in European Union as Vidaza for:
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Approved in United States as Vidaza for:
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Approved in Canada as Vidaza for:
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Approved in Japan as Vidaza for:

Find a Clinic Near You

Who Is Running the Clinical Trial?

Syros Pharmaceuticals

Lead Sponsor

Trials
6
Recruited
1,000+
Unbiased ResultsWe believe in providing patients with all the options.
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