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Tamibarotene Plus Venetoclax/Azacitidine in Participants With Newly Diagnosed AML

About

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 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.

Primary Purpose
Treatment
Study Type
Interventional
Phase
Phase II

Eligibility

Gender
All
Healthy Volunteers
No
Minimum Age
18 Years
Maximum Age
N/A

Inclusion Criteria:

  • Participants must be RARA-positive based on the investigational assay.
  • 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 study entry 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 prior to enrollment.

Exclusion Criteria:

  • Participants have APL.
  • Participants have known active central nervous system involvement with AML.
  • Prior treatment 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.

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Study Stats
Protocol No.
21-000893
Category
Hematology-Oncology
Oncology
Contact
Bruck Habtemariam
Location
  • UCLA Westwood
For Providers
NCT No.
NCT04905407
For detailed technical eligibility, visit ClinicalTrials.gov.