Actively Recruiting
Venetoclax and Decitabine in R/R T-ALL
Led by Seoul National University Hospital · Updated on 2026-02-02
28
Participants Needed
3
Research Sites
187 weeks
Total Duration
On this page
Sponsors
S
Seoul National University Hospital
Lead Sponsor
K
Korean Society of Hematology
Collaborating Sponsor
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
Venetoclax and Decitabine in R/R T-ALL
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Adults aged 19 years or older but less than 80 years
- Eastern Cooperative Oncology Group Performance Score (ECOG PS) 64 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 screening, a calculated glomerular filtration rate (GFR) 64 30 mL/min according to the Cockcroft-Gault formulas, or creatinine 64 1.4, total bilirubin 64 3.0 mg/dL, and AST and ALT < x5 upper limit of normal (ULN) (bilirubin elevation due to Gilbert's syndrome or liver enzyme elevation due to leukemia/lymphoma infiltration may be allowed)
- Individuals who agree to contraceptive measures for 3 months during treatment and 3 months after completion
You will not qualify if you...
- Individuals in complete remission with previous treatment if relapse or resistance is not confirmed by bone marrow or imaging/tissue examination
- Individuals previously treated with venetoclax + decitabine for T-lymphoblastic leukemia/lymphoma (except if treated for other cancers over 1 year ago)
- Pregnant or breastfeeding individuals
- Individuals who received systemic anticancer chemotherapy or participated in a clinical trial within the past 2 weeks
- Individuals with active leukemia in the central nervous system
- Individuals with other active cancers requiring current treatment (exceptions may apply for cured or slow-progressing cancers)
- Individuals with active HIV, hepatitis B, or hepatitis C infection (some exceptions with specialist consent)
- Uncontrolled bleeding, infection, or mental illness
- Individuals unable to understand informed consent or communicate adequately
- Individuals judged by investigators as unsuitable for participation or with unwillingness to comply with study procedures
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 3 locations
1
Seoul National University Bundang Hospital
Seongnam-si, South Korea, 13620
Not Yet Recruiting
2
Seoul National University Hospital
Seoul, South Korea, 03080
Not Yet Recruiting
3
Seoul National University Hospital
Seoul, South Korea, 03080
Actively Recruiting
Research Team
D
Dong-Yeop Shin, MD, PhD.
CONTACT
E
EunHee Park, RN
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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