Venetoclax and Decitabine in R/R T-ALL

Prior treatment

• Individuals in complete remission with previous treatment, if relapse or resistance is not confirmed by bone marrow examination or imaging/tissue examination.
• Individuals who previously received venetoclax + decitabine treatment for T-lymphoblastic leukemia/lymphoma (participants who received venetoclax + decitabine treatment for a different type of cancer \[e.g., acute myeloid leukemia\] and have elapsed more than 1 year since the last treatment are allowed).
• Individuals who received systemic anticancer chemotherapy or participated in a clinical trial treatment within the past 2 weeks.

Other illness

• Individuals with a cancer type other than T-lymphoblastic leukemia/lymphoma that requires current active treatment (participants with a cancer type that has already been cured or is in a slow-progressing state without treatment, as determined by surgery/radiation/chemotherapy, may participate under the consultation of the clinical trial investigator).
• Individuals with active human immunodeficiency virus (HIV) infection, hepatitis B/hepatitis C infection (participants without evidence of viral particles through PCR testing may be enrolled with the consent of an infectious disease specialist or hepatologist).
• Uncontrolled bleeding.
• Uncontrolled infection (bacterial, fungal, viral).
• Uncontrolled mental illness.

Other

• Pregnant or breastfeeding individuals.
• Individuals with active leukemia involving the central nervous system.
• Individuals who do not understand the informed consent or have difficulty in adequate communication, making them inappropriate for participation in the clinical trial.
• Cases where the investigator judges that patient evaluation may be hindered or participation in the clinical trial is not appropriate.
• Individuals who have a negative attitude towards participating in the clinical trial or who are unwilling to comply with the treatment and specimen collection schedule specified in the study protocol.

• Adults aged 19 years or older but less than 80 years
• Eastern Cooperative Oncology Group Performance Score (ECOG PS) ≤ 2
• Confirmed diagnosis of T-cell lymphoblastic leukemia/lymphoma according to the 2016 World Health Organization criteria, with relapse or failure to achieve complete remission despite induction chemotherapy
• Patients with peripheral blood leukocytes \<50,000/uL (reducing white blood cell count through hydroxyurea or leukapheresis prior to trial enrollment is allowed)
• At the time of screening, a calculated glomerular filtration rate (GFR) ≥ 30 mL/min according to the Cockcroft-Gault formulas, or creatinine ≤ 1.4, total bilirubin ≤ 3.0 mg/dL, and AST and ALT \< x5 upper limit of normal (ULN) (however, if bilirubin elevation is due to Gilbert\'s syndrome or liver enzyme elevation is due to infiltration of leukemia/lymphoma, enrollment may be allowed even if the above conditions are exceeded)
• Individuals who agree to the following contraceptive measures for a period of 3 months during treatment and for 3 months after completion: