Decitabine and venetoclax tested in relapsed adult T-cell leukemia
Tests decitabine with venetoclax in adults whose T-cell leukemia returned or did not respond.
Plain-language title generated from the registry record
Registry title: Venetoclax and Decitabine in R/R T-ALL
Key facts
- Where
- Seongnam-si and Seoul, South KoreaSee the 2 sites
- Phase
- Phase 2
Could this be for you?
Answer for yourself. This is not a decision: only the study team can say whether you can take part.
- Are you between 19 and 80 years old?
Source: NCT06712121, who can take part
Where in South Korea
- Seoul National University Bundang HospitalSeongnam-si, South KoreaNot yet recruiting
- Seoul National University HospitalSeoul, South KoreaNot yet recruiting
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Trial details
- Who runs it
- Seoul National University Hospital
- Trial code
- NCT06712121
- Record updated
- 2 February 2026
- Original description
The goal of this phase 2 clinical trial is to test the efficacy of decitabine and venetoclax combination chemotherapy in relapsed or refractory adult T-cell acute lymphoblastic leukemia/lymphoblastic lymphoma.Read full original descriptionShow less
A Phase 2 Clinical Trial to Evaluate the Efficacy of VEnetoclax and DEciTabine in Relapsed/Refractory Adult T-acute Lymphoblastic lEukemia/Lymphoma
The goal of this phase 2 clinical trial is to test the efficacy of decitabine and venetoclax combination chemotherapy in relapsed or refractory adult T-cell acute lymphoblastic leukemia/lymphoblastic lymphoma.
This study use a modified regimen of decitabine and venetoclax.
Inclusion: 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:.
Exclusion: 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; 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; 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.