Status:
TERMINATED
Tamibarotene Plus Venetoclax/Azacitidine in Participants With Newly Diagnosed Acute Myeloid Leukemia (AML)
Lead Sponsor:
Syros Pharmaceuticals
Conditions:
Acute Myeloid Leukemia
Eligibility:
All Genders
18+ years
Phase:
PHASE2
Brief 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 wit...
Detailed 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 dos...
Eligibility Criteria
Inclusion
- 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.
- 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 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.
Exclusion
- 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.
Key Trial Info
Start Date :
August 26 2021
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
August 12 2024
Estimated Enrollment :
66 Patients enrolled
Trial Details
Trial ID
NCT04905407
Start Date
August 26 2021
End Date
August 12 2024
Last Update
February 24 2025
Active Locations (28)
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1
City of Hope
Duarte, California, United States, 91010
2
UCLA Medical Center Division of Hematology/Oncology
Los Angeles, California, United States, 90095
3
University of Colorado
Denver, Colorado, United States, 80204
4
Sarah Cannon Research Institute at Colorado Blood Cancer Institute
Denver, Colorado, United States, 80218