Study of ADI-PEG 20, Venetoclax and Azacitidine in Acute Myeloid Leukemia

Description

Pegylated arginine deiminase (ADI-PEG 20) will be combined with venetoclax and azacitidine for treatment of subjects with previously treated or untreated with high risk factor acute myeloid leukemia (AML). Venetoclax and azacitidine are front-line therapy for such patients, and ADI-PEG 20 will be added to this regimen in a phase IA/B study.

Conditions

Acute Myeloid Leukemia, Adult

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Study Overview

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Study Details

Study overview

Pegylated arginine deiminase (ADI-PEG 20) will be combined with venetoclax and azacitidine for treatment of subjects with previously treated or untreated with high risk factor acute myeloid leukemia (AML). Venetoclax and azacitidine are front-line therapy for such patients, and ADI-PEG 20 will be added to this regimen in a phase IA/B study.

Phase IA/B Combination Study of ADI-PEG 20, Venetoclax and Azacitidine in Patients with Acute Myeloid Leukemia (AML)

Study of ADI-PEG 20, Venetoclax and Azacitidine in Acute Myeloid Leukemia

Condition
Acute Myeloid Leukemia, Adult
Intervention / Treatment

-

Contacts and Locations

Miami

Sylvester Comprehensive Cancer Center, Miami, Florida, United States, 33136

Skokie

Orchard Healthcare Research Inc, Skokie, Illinois, United States, 60077

Charlotte

Levine Cancer Institute, Charlotte, North Carolina, United States, 28204

Houston

MD Anderson Cancer Center, Houston, Texas, United States, 77030

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

For general information about clinical research, read Learn About Studies.

Eligibility Criteria

  • * Cohort 1: Previously treated (relapsed/recurrent) or refractory AML based on the 2022 revision to the World Health Organization (WHO) criteria (Arber 2022)
  • * Cohort 2: Untreated AML per 2022 WHO (Arber 2022) criteria with high-risk features and not a candidate for intensive chemotherapy because of age 60 years or older, age-related comorbidities, cardiac disease, prior anthracycline use, high probability of treatment-related mortality, or otherwise would not benefit from intensive chemotherapy treatment.
  • * Age ≥ 18 years
  • * Life expectancy reasonably adequate for evaluating the treatment
  • * White blood cell (WBC) count of 10 × 109/L or less. (Use of hydroxyurea to control WBC is allowed till 48 hours prior to protocol treatment)
  • * Adequate renal function: Creatinine ≤ 1.5 x upper limit of normal (ULN) or creatinine clearance \> 40 mL/minute (measured or calculated according to the Cockcroft-Gault formula)
  • * Adequate liver function
  • * Total bilirubin ≤ 1.5 x ULN
  • * ALT and AST both ≤ 2.5 x institutional ULN or ≤ 5 times the ULN for patients with leukemic involvement of liver
  • * Prior treatments as follows:
  • 1. Cohort 1: \>2 cycles of prior combination treatment with venetoclax+hypomethelating agent (i.e. azacitidine, decitabine) is exclusionary. All other prior treatment for antecedent hematological disorders and/or for AML is permitted.
  • 2. Cohort 2: Prior treatment for antecedent hematological disorders with venetoclax or chemotherapy or any prior treatment for their AML is exclusionary. However, treatment with other agents, including hydroxyurea or ≤2 cycles of hypomethylating agent (i.e. azacitidine, decitabine), for MDS or myeloproliferative neoplasm is permitted.
  • * Cohort 2: Favorable risk AML per European LeukemiaNet (ELN) 2022 criteria (Döhner 2022)
  • * Known active CNS involvement by leukemia

Ages Eligible for Study

18 Years to 99 Years

Sexes Eligible for Study

ALL

Accepts Healthy Volunteers

No

Collaborators and Investigators

Polaris Group,

John S Bomalaski, MD, STUDY_DIRECTOR, Polaris Group

Study Record Dates

2025-12