NCT06712121 Venetoclax and Decitabine in R/R T-ALL
| NCT ID | NCT06712121 |
| Status | Recruiting |
| Phase | Phase 2 |
| Sponsor | Seoul National University Hospital |
| Condition | T Lymphoblastic Leukemia/Lymphoma |
| Study Type | INTERVENTIONAL |
| Enrollment | 28 participants |
| Start Date | 2025-01-30 |
| Primary Completion | 2027-08-31 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
In Phase 2, researchers evaluate early signs of effectiveness. You may be randomized to receive the active treatment or a comparator. Monitoring continues closely.
This trial targets 28 participants in total. It began in 2025-01-30 with a primary completion date of 2027-08-31.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
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.
Eligibility 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.
Contact & Investigator
Frequently Asked Questions
Who can join the NCT06712121 clinical trial?
This trial is open to participants of all sexes, aged 19 Years or older, up to 80 Years, studying T Lymphoblastic Leukemia/Lymphoma. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT06712121 trial and what does that mean for participants?
Phase 2 trials evaluate whether the treatment shows signs of effectiveness while continuing to monitor safety. More participants are enrolled than in Phase 1 to help refine the treatment protocol.
Is NCT06712121 currently recruiting?
Yes, NCT06712121 is actively recruiting participants. Contact the research team at shindongyeop@snu.ac.kr for enrollment information.
Where is the NCT06712121 trial being conducted?
This trial is being conducted at Seongnam-si, South Korea, Seoul, South Korea, Seoul, South Korea.
Who is sponsoring the NCT06712121 clinical trial?
NCT06712121 is sponsored by Seoul National University Hospital. The trial plans to enroll 28 participants.
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