ICP-248 in Combination with Azacitidine in Treatment-Naïve Subjects with Acute Myelogenous Leukemia(AML) or Previously Treated Relapsed/Refractory Subjects with Acute Myelogenous Leukemia(R/R AML).

Launched by BEIJING INNOCARE PHARMA TECH CO., LTD. · Oct 22, 2024

Keywords

ClinConnect Summary

This clinical trial is studying the combination of two treatments, ICP-248 and azacitidine, for patients with Acute Myelogenous Leukemia (AML). AML is a type of cancer that affects the blood and bone marrow. The trial is looking to see if this combination is safe, how the body processes the drugs, and if it can help patients who have never been treated for AML or those whose cancer has come back after treatment.

To participate, you need to have a confirmed diagnosis of AML, and there are specific age and health requirements. For example, if you're 60 years or older, you may be eligible, or if you're younger, you should have certain health issues that make standard chemotherapy unsafe. Participants can expect to spend time in the study to monitor how they respond to the treatment, and the trial is currently recruiting individuals of all genders. It’s important to know that if you've had certain previous treatments for AML or have specific health conditions, you may not qualify for this study.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• * Eligible subjects must meet all of the following criteria:
• • 1. Subject must have confirmation of diagnosis of AML, except for acute promyelocytic leukemia (APL) per 2016 World Health Organization (WHO) criteria.
• • 2. Previously treated relapsed/refractory AML subjects per 2017 European Leukemia Net (ELN) criteria.
• 3. Treatment-naïve AML subjects should be:
• • ≥60 years of age;OR
• * ≥18 years and \<60 years will be eligible if the subject has at least one of the following co-morbidities, which make the subject unfit for intensive chemotherapy:
• • 1. Eastern Cooperative Oncology Group (ECOG) Performance Status (PS) of 2 - 3;
• • 2. History of congestive heart failure requiring treatment or Ejection Fraction (EF) ≤ 50% or chronic stable angina;
• • 3. Clinically significant respiratory failure or diffusing capacity for carbon monoxide (DLCO) ≤ 65% or forced expiratory volume in 1 second (FEV1)
• • ≤ 65%;
• • 4. Creatinine clearance ≥ 30 mL/min to \< 45 mL/min (calculated by Cockcroft Gault formula);
• • 5. Total bilirubin \> 1.5 to ≤ 3.0 ×upper limit of normal (ULN);
• • 6. Any other comorbidity that the Investigator judges to be incompatible with intensive chemotherapy must be reviewed and approved by the Sponsor medical monitor before study enrollment.
• • 4. Subject must have a projected life expectancy of at least 12 weeks.
• • 5. Subject must have adequate renal function as demonstrated by a creatinine clearance≥ 30 mL/min; determined via urine collection for 24-hour creatinine clearance or by the Cockcroft-Gault formula.
• • 6. Subject must have adequate liver function.
• Exclusion Criteria:
• • 1. Previously treated subject, who are refractory to previous azacitidine-based therapy defined as failure to achieve CR/CRi/MLFS per 2017 ELN criteria or intolerable to previous azacitidine-based treatment defined as discontinuation from azacitidine-based therapy due to clearly documented toxicity.
• • 2. Previously treated subject, who are refractory to previous BCL-2 inhibitor-based therapy defined as failure to achieve CR/CRi/MLFS per 2017 ELN criteria or intolerable to previous BCL-2 inhibitor-based treatment defined as discontinuation from BCL-2 inhibitor-based therapy due to clearly documented toxicity.
• • 3. Subject has acute promyelocytic leukemia (French-American-British Class M3 AML) or AML with t(8;21)(q22;q22.1)/RUNX1::RUNX1T1.
• • 4. Subject has known central nervous system (CNS) leukemia.
• • 5. Subject has a history of myeloproliferative neoplasm (MPN) including polycythemia vera, myelofibrosis, essential thrombocythemia, or chronic myelogenous leukemia.
• • 6. Subject has a white blood cell count \> 25 × 109/L (Cytoreductive therapy for leucocytosis are permitted to meet this criterion).
• • 7. The serologic status suggestive of active hepatitis B or C virus infection.
• • 8. History of immunodeficiency, including a positive human immunodeficiency virus (HIV) antibody test.
• • 9. Subjects have another active malignancy within the past 2 years before study entry, except for who have received curatively treated.
• • 10. History of significant cardiovascular disease.