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Venetoclax plus decitabine for relapsed or refractory adult T‑cell acute lymphoblastic leukemia/lymphoblastic lymphoma

Q: Who is a good fit for trial NCT06712121?

Adults aged 19–79 with relapsed or refractory T‑ALL/LBL, ECOG ≤2, acceptable kidney and liver function, and peripheral white blood cell count under 50,000/µL who can attend the study centers are the intended candidates.

Q: Who should not enroll in trial NCT06712121?

Patients with newly diagnosed disease, severe organ dysfunction or active uncontrolled infection, age 80 or older, or prior intolerance to venetoclax or decitabine are unlikely to benefit from this protocol.

Q: What is the potential benefit of this trial?

If successful, the combination could increase remission rates, extend survival, and help more patients reach curative options such as stem cell transplant.

Q: How have similar studies performed?

Combining venetoclax with hypomethylating agents like decitabine has shown promising responses in acute myeloid leukemia and in limited early reports for T‑cell lymphoid malignancies, but robust large‑scale evidence in T‑ALL/LBL is still lacking.

A Phase 2 Clinical Trial to Evaluate the Efficacy of VEnetoclax and DEciTabine in Relapsed/Refractory Adult T-acute Lymphoblastic lEukemia/Lymphoma

Phase 2 Interventional Seoul National University Hospital · NCT06712121

This project tests whether seven days of decitabine combined with three weeks of venetoclax can help adults with relapsed or refractory T‑cell acute lymphoblastic leukemia/lymphoblastic lymphoma achieve remission.

Quick facts

Phase	Phase 2
Study type	Interventional
Enrollment	28 (estimated)
Ages	19 Years to 80 Years
Sex	All
Sponsor	Seoul National University Hospital Academic / other
Drugs / interventions	chemotherapy, radiation
Locations	3 sites (Seongnam-si and 2 other locations)
Trial ID	NCT06712121 on ClinicalTrials.gov

What this trial studies

This is a phase 2, investigator‑led trial run in collaboration with the Korean adult ALL working party (KALLWP) and a lymphoma consortium (CISL) that enrolls adults with relapsed or refractory T‑ALL/LBL. Participants receive a modified regimen of decitabine for seven days plus up to three weeks of venetoclax per cycle for up to 12 cycles. Key eligibility includes age 19–79, ECOG performance status ≤2, peripheral leukocytes <50,000/µL (with pre‑treatment lowering allowed), and minimum kidney and liver function cutoffs. The primary aim is to see whether this combination produces meaningful remission rates in this difficult‑to‑treat population.

Who should consider this trial

Good fit: Adults aged 19–79 with relapsed or refractory T‑ALL/LBL, ECOG ≤2, acceptable kidney and liver function, and peripheral white blood cell count under 50,000/µL who can attend the study centers are the intended candidates.

Not a fit: Patients with newly diagnosed disease, severe organ dysfunction or active uncontrolled infection, age 80 or older, or prior intolerance to venetoclax or decitabine are unlikely to benefit from this protocol.

Why it matters

Potential benefit: If successful, the combination could increase remission rates, extend survival, and help more patients reach curative options such as stem cell transplant.

How similar studies have performed: Combining venetoclax with hypomethylating agents like decitabine has shown promising responses in acute myeloid leukemia and in limited early reports for T‑cell lymphoid malignancies, but robust large‑scale evidence in T‑ALL/LBL is still lacking.

Eligibility criteria

Show full inclusion / exclusion criteria

Inclusion Criteria:

* 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 \&lt;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 \&lt; x5 upper limit of normal (ULN) (however, if bilirubin elevation is due to Gilbert\&#39;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 Criteria:

* 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).
* Pregnant or breastfeeding individuals.
* Individuals who received systemic anticancer chemotherapy or participated in a clinical trial treatment within the past 2 weeks.
* Individuals with active leukemia involving the central nervous system.
* 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.
* 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.

Where this trial is running

Seongnam-si and 2 other locations

Seoul National University Bundang Hospital — Seongnam-si, South Korea (Not_yet_recruiting)
Seoul National University Hospital — Seoul, South Korea (Not_yet_recruiting)
Seoul National University Hospital — Seoul, South Korea (Recruiting)

Study contacts

Study coordinator: Dong-Yeop Shin, MD, PhD.
Email: shindongyeop@snu.ac.kr
Phone: 82+220727209

How to participate

Review the eligibility criteria above with your treating physician.
Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.

View on ClinicalTrials.gov → Find more trials like this →

Conditions T Lymphoblastic Leukemia/Lymphoma T lymphoblastic leukemia/lymphoma venetoclax decitabine

Last reviewed 2026-06-13 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.