Venetoclax plus decitabine for relapsed or refractory adult T‑cell acute lymphoblastic leukemia/lymphoblastic lymphoma
Official title: A Phase 2 Clinical Trial to Evaluate the Efficacy of VEnetoclax and DEciTabine in Relapsed/Refractory Adult T-acute Lymphoblastic lEukemia/Lymphoma
Run by Seoul National University Hospital · NCT06712121 · Data updated 2026-11-12
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 |
| Ages | 19 Years to 80 Years |
| Sex | All |
| Enrollment | 28 (estimated) |
| Sponsor | Seoul National University Hospital Academic / other |
| Drugs / interventions | chemotherapy, radiation |
| Locations | 3 sites (Seongnam-si and 2 other locations) |
| Status | Recruiting |
| Started | January 30, 2025 |
| Main results expected | August 31, 2027 |
| Study ends | August 31, 2028 |
| Registry record updated | February 2, 2026 |
| Trial ID | NCT06712121 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a 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.
✕Probably 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.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
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.
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 gone: 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.
Who can join: the full rules
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 \<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 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 it's running
-
Seoul National University Hospital
Seoul, South Korea Recruiting -
Seoul National University Bundang Hospital
Seongnam-si, South Korea Not yet recruiting -
Seoul National University Hospital
Seoul, South Korea Not yet recruiting
Study contacts
- Study coordinator: Dong-Yeop Shin, MD, PhD.
- Email: shindongyeop@snu.ac.kr
- Phone: 82+220727209
Similar studies
Other studies for the same condition or treatment. Recruiting studies are listed first.
-
supCD7 CAR-T for relapsed or refractory CD7-positive T-cell leukemia/lymphoma and AML
This treatment will try supCD7 CAR‑T cells to see if they help adults whose CD7‑positive T‑cell leukemia/lymphoma or AML has come back or not responded to prior therapy.
-
Universal CD7 CAR-T therapy for relapsed or refractory CD7-positive blood cancers
This trial will test whether universal CD7 CAR-T cells can safely reduce disease in adults whose CD7-positive AML or T-ALL/LBL has relapsed or stopped responding to prior treatments.
-
Using CD7 CAR-T cells to treat T-cell lymphoma and leukemia
This study is testing a new type of treatment using CD7 CAR-T cells to see if it can help adults with T-cell lymphoma and leukemia who haven't had success with other therapies.
-
Virtual buddy movement program to improve motor and social skills in children in remission from leukemia
This 12-week program will test whether virtual buddy-led movement therapy helps children aged 5–12 in remission from precursor cell lymphoblastic leukemia improve motor skills and social interaction.
-
Electronic mindfulness-based music therapy for patients receiving stem cell transplantation
This trial tests an eHealth mindfulness-based music therapy to see if it improves quality of life and reduces symptoms for adults undergoing stem cell transplantation.
-
Phase I CAR T-cell therapy for relapsed or refractory acute lymphoblastic leukemia in children, adolescents, and young adults
This phase I study will test two CAR T-cell approaches to see if they are safe and feasible for children and young adults with relapsed or refractory B-ALL or T-ALL.
How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.