ABC Maintenance Therapy for AML

Korábbi kezelés

• History of AML that was refractory to or did not achieve remission with prior treatment containing Venetoclax, Chidamide, or Azacitidine.
• Patients who have undergone Hematopoietic Stem Cell Transplantation (HSCT).

Más betegség

• Patients with a history of extramedullary leukemia, unless central nervous system (CNS) involvement is controlled.
• Uncontrolled comorbidities, including but not limited to ongoing or active uncontrolled infection, symptomatic congestive heart failure, unstable angina, arrhythmia, or psychiatric illness/social situations that would compromise compliance with the protocol.
• History of hypersensitivity to any component of the study protocol.
• Patients with active Central Nervous System (CNS) disease.

Laborértékek

• Laboratory values that do not meet the following criteria: Total Bilirubin ≤ 1.5 × Upper Limit of Normal (ULN); Serum Creatinine ≤ 2.5 × ULN; Absolute Neutrophil Count (ANC) > 0.5 × 10⁹/L; Platelet Count ≥ 30 × 10⁹/L.

Egyéb

• Diagnosis of Acute Promyelocytic Leukemia (APL) or FAB subtype M3 AML.
• Pregnant women.
• Patients with Relapsed or Refractory (R/R) AML.

• Patients aged 18 to 80 years with newly diagnosed Acute Myeloid Leukemia (AML)
• Patients who have achieved their first Complete Remission (CR) or Complete Remission with incomplete hematologic recovery (CRi) at the time of enrollment, following induction therapy with intensive chemotherapy and at least 2 cycles of consolidation therapy. Remission must have been achieved within 4 months (±7 days) prior to enrollment.
• Eastern Cooperative Oncology Group (ECOG) performance status ≤ 3.
• Women of childbearing potential are eligible if they meet the following conditions:
  • A negative serum or urine pregnancy test is performed within 10-14 days prior to enrollment, and a second negative pregnancy test is performed within 24 hours prior to the initiation of treatment. Both negative results are required to meet the criteria for treatment initiation.
  • They agree to practice abstinence or use two effective methods of contraception during the treatment period and for 28 days after discontinuation of the study drug.
• Male patients with female partners of childbearing potential are eligible if they agree to practice abstinence or use two effective methods of contraception during the treatment period and for 28 days after discontinuation of the study drug.
• Women of childbearing potential must comply with scheduled pregnancy tests.
• Ability to understand and sign the Informed Consent Form (ICF).