Acute Myeloid Leukemia, Adult Clinical Trial
Official title:
Phase IA/B Combination Study of ADI-PEG 20, Venetoclax and Azacitidine in Patients With Acute Myeloid Leukemia (AML)
Verified date | May 2023 |
Source | Polaris Group |
Contact | Nicole DeFord |
Phone | 619-808-5065 |
ndeford[@]polarispharma.com | |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Recruiting |
Enrollment | 60 |
Est. completion date | December 2025 |
Est. primary completion date | July 2025 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years to 99 Years |
Eligibility | Inclusion Criteria: - Cohort 1: Previously treated (relapsed/recurrent) or refractory AML based on the 2016 revision to the World Health Organization (WHO) criteria (Arber 2016) - Cohort 2: Untreated AML per 2016 WHO (Arber 2016) 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 Exclusion Criteria: - 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 |
Country | Name | City | State |
---|---|---|---|
United States | Levine Cancer Institute | Charlotte | North Carolina |
United States | MD Anderson Cancer Center | Houston | Texas |
United States | Orchard Healthcare Research Inc | Skokie | Illinois |
Lead Sponsor | Collaborator |
---|---|
Polaris Group |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Determine the RP2D of ADI-PEG 20 in combination with venetoclax and azacitidine, per the number of subjects with treatment-related adverse events by current CTCAE | 6 months | ||
Secondary | Determine preliminary evidence of tumor activity, per the revised 2017 European LeukemiaNet criteria | 2 years | ||
Secondary | Determine the peripheral blood arginine levels of ADI-PEG 20 in combination with venetoclax and azacitidine | 2 years | ||
Secondary | Determine the peripheral blood citrulline levels of ADI-PEG 20 in combination with venetoclax and azacitidine | 2 years | ||
Secondary | Determine the anti-drug antibodies of ADI-PEG 20 in combination with venetoclax and azacitidine | 2 years |
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