Acute Myeloid Leukemia Clinical Trial

Tamibarotene Plus Venetoclax/Azacitidine in Participants With Newly Diagnosed AML

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.

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Full 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 tamibarotene dose to be combined with the approved dose and schedule of venetoclax/azacitidine in Part 2. In Part 2, participants will be randomized 1:1 to receive either tamibarotene/venetoclax/azacitidine or venetoclax/azacitidine to compare the 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.

View Eligibility Criteria

Eligibility Criteria

Note: all inclusion/exclusion criteria should be met prior to the first dose of venetoclax/azacitidine on Cycle 1 Day 1 with the exception of the RARA-biomarker test result referenced in inclusion criterion 2, which should be positive by Cycle 1 Day 8 to continue treatment on study.

Inclusion Criteria:

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.

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 Cycle 1 Day 1 Visit 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 mLmin 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.

Exclusion Criteria:

Participants have APL.
Participants have known active central nervous system involvement with AML.
Prior treatment (before Cycle 1 Day 1) 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.

Study is for people with:

Acute Myeloid Leukemia

Phase:

Phase 2

Estimated Enrollment:

95

Study ID:

NCT04905407

Recruitment Status:

Recruiting

Sponsor:

Syros Pharmaceuticals

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There are 8 Locations for this study

See Locations Near You

City of Hope
Duarte California, 91010, United States More Info
Brian Ball, MD
Contact
626-218-2405
Brian Ball, MD
Principal Investigator
University of Colorado
Denver Colorado, 80204, United States More Info
Olivia Ondracek
Contact
720-848-9384
[email protected]
Christine McMahon, MD
Principal Investigator
Colorado Blood Cancer Institute
Denver Colorado, 80218, United States More Info
Sonya Grohowski
Contact
720-754-8067
Alizera Eghtedar, MD
Principal Investigator
BRCR Global
Plantation Florida, 33322, United States More Info
Ines Padron
Contact
561-447-0614
[email protected]
Jason Tache, DO
Principal Investigator
Saint Alphonsus Regional Medical Center
Boise Idaho, 83706, United States More Info
Laura O'Brien
Contact
208-367-3481
[email protected]
Karl Schultheiss, MD
Principal Investigator
HCA Midwest Research Medical Center
Kansas City Missouri, 64132, United States More Info
Lauren Wright
Contact
816-276-4227
Suman Kambhampati, MD
Principal Investigator
Memorial Sloan Kettering Cancer Center
New York New York, 10065, United States More Info
Eytan Stein
Contact
[email protected]
Eytan Stein, MD
Principal Investigator
MD Anderson Cancer Center
Houston Texas, 77030, United States More Info
Michelle Velasquez
Contact
713-745-9852
Gautam Borthakur, MD
Principal Investigator

How clear is this clinincal trial information?

Study is for people with:

Acute Myeloid Leukemia

Phase:

Phase 2

Estimated Enrollment:

95

Study ID:

NCT04905407

Recruitment Status:

Recruiting

Sponsor:


Syros Pharmaceuticals

How clear is this clinincal trial information?

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