T Lymphoblastic Leukemia/LymphomaPhase 2NCT06712121
Venetoclax and Decitabine in R/R T-ALL
A Phase 2 study testing decitabine plus venetoclax in people with T Lymphoblastic Leukemia/Lymphoma, run by Seoul National University Hospital at 3 sites in South Korea.
Trial 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. Read more about this study
- Who is it for?
- Ages 19 to 80 years
- Conditions the study is for
- T Lymphoblastic Leukemia/Lymphoma
- What is being tested?
- decitabine plus venetoclax
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 28 participants
- Where
- 3 sitesSouth Korea
- Study dates
- 30 Jan 2025to 31 Aug 2028
- Phase
- Phase 2
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 19 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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:
Who cannot join
- 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).
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- 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.
Trial locations and contacts
3 sites in 1 country. Contact the study team or a site near you to ask about taking part.
EunHee Park, RN contact
South Korea3 sites, 3 recruiting
- Not yet recruiting
Seoul National University Bundang Hospital
Seongnam-si, 13620
Sang-A Kim, 82-032-1588-3369, sanga0906@naver.com
- Not yet recruiting
Seoul National University Hospital
Seoul, 03080
Dong-Yeop Shin, MD, PhD, +82-2-2072-7209, shindongyeop@snu.ac.kr
Dong-Yeop Shin, MD, PhD
- Recruiting
Seoul National University Hospital
Seoul, 03080
Dong-Yeop Shin, 82-2-2072-7209, shindongyeop@snu.ac.kr
Eunhee Park, Coordinator, epark@snuh.org
About this study
Official title: 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.
Read the detailed description
Our study is conducted in collaboration with Korean adult acute lymphoblastic leukemia working party (KALLWP) and consortium for improving survival of lymphoma (CISL). This study recruits adult patients with R/R T-ALL/LBL and treated with 7-day decitabine plus 3 weeks of venetoclax up to 12 cycles.
- Conditions
- T Lymphoblastic Leukemia/Lymphoma
- Being tested
- decitabine plus venetoclax
- Keywords
- T lymphoblastic leukemia/lymphoma, venetoclax, decitabine
- Medical subject headings
- Lymphoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
decitabine plus venetoclaxDrug
decitabine 20mg/m2 for 7 days venetoclax 400mg daily for 21 days
| Study group | Role | What they receive |
|---|---|---|
| decitabine and venetoclax arm | Experimental | arm treated with venetoclax plus decitabine Receives: Drug: decitabine plus venetoclax |
What is being measured
The primary outcome is the main question the study is designed to answer.
The rate of composite Complete remission
CR: complete remission CRh: complete remission with partial hematologic recovery CRi: complete remission with incomplete hematologic recovery MLFS: morphologic leukemia-free state
Measured: 1 year
Secondary outcomes (6)
Composite overall response rate
cORR: CR/CRh/CRi/MLFS+PR
Measured: 1 year
Clinical benefit rate
CR: complete remission CRh: complete remission with partial hematologic recovery CRi: complete remission with incomplete hematologic recovery MLFS: morphologic leukemia-free state PR: partial remission stable disease
Measured: 1 year
Duration of response
by months
Measured: 1 year
Bridging to allogeneic hematopoietic stem cell transplantation (HSCT)
by rate
Measured: 1 year
Progression-free survival (PFS)
by months
Measured: 1 year
Overall survival (OS)
by months
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Dec 2024
- Study start30 Jan 2025
- Primary completion31 Aug 2027 (estimated)
- Study completion31 Aug 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for T Lymphoblastic Leukemia/LymphomaStudies of the same condition, open and under way.
- More trials run by Seoul National University HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 28 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Seoul National University Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Korean Society of Hematology
- Responsible party
- Principal investigator, Dong-Yeop Shin, Seoul National University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06712121
- Sponsor's protocol ID
- VEDETTE
- Status last verified
- Jan 2026
- First submitted
- 26 Nov 2024
- Last updated
- 2 Feb 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 2 Clinical Trial to Evaluate the Efficacy of VEnetoclax and DEciTabine in Relapsed/Refractory Adult T-acute Lymphoblastic lEukemia/Lymphoma
- ClinicalTrials.gov ID
- NCT06712121
- Acronym / sponsor ID
- VEDETTE
- Conditions
- T Lymphoblastic Leukemia/Lymphoma
- Keywords
- T lymphoblastic leukemia/lymphoma, venetoclax, decitabine
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 28 participants (estimated)
- Lead sponsor
- Seoul National University HospitalUniversity, hospital or other
- Collaborators
- Korean Society of Hematology
- Study start
- 30 Jan 2025 (actual)
- Primary completion
- 31 Aug 2027 (estimated)
- Study completion
- 31 Aug 2028 (estimated)
- First posted
- 2 Dec 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
Our study is conducted in collaboration with Korean adult acute lymphoblastic leukemia working party (KALLWP) and consortium for improving survival of lymphoma (CISL). This study recruits adult patients with R/R T-ALL/LBL and treated with 7-day decitabine plus 3 weeks of venetoclax up to 12 cycles.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| decitabine and venetoclax arm | Experimental | Drug: decitabine plus venetoclaxarm treated with venetoclax plus decitabine |
Who may qualify
- Ages
- 19 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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)
Key exclusion criteria (13 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| decitabine plus venetoclaxdecitabine 20mg/m2 for 7 days venetoclax 400mg daily for 21 days | Drug | decitabine and venetoclax arm |
Primary outcome
The rate of composite Complete remission
Time frame: 1 year
CR: complete remission CRh: complete remission with partial hematologic recovery CRi: complete remission with incomplete hematologic recovery MLFS: morphologic leukemia-free state
6 secondary outcomes
Composite overall response rate
Time frame: 1 year
Clinical benefit rate
Time frame: 1 year
Duration of response
Time frame: 1 year
Bridging to allogeneic hematopoietic stem cell transplantation (HSCT)
Time frame: 1 year
Progression-free survival (PFS)
Time frame: 1 year
Overall survival (OS)
Time frame: 1 year
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Feb 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
EunHee Park, RN contact
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing decitabine plus venetoclax in people with T Lymphoblastic Leukemia/Lymphoma, run by Seoul National University Hospital at 3 sites in South Korea.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 2 Feb 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Dong-Yeop Shin, MD, PhD. (82+220727209, shindongyeop@snu.ac.kr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The rate of composite Complete remission (time frame: 1 year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Feb 2026.