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RecruitingNCT06712121Updated Feb 2, 2026

Venetoclax and Decitabine in R/R T-ALL

A Phase 2 interventional study of decitabine plus venetoclax in T Lymphoblastic Leukemia/Lymphoma, sponsored by Seoul National University Hospital. Recruiting at 3 sites in South Korea. Open to participants aged 19 Years to 80 Years. Per ClinicalTrials.gov, last updated 2026-02-02.

Sponsored by Seoul National University Hospital · Phase 2, Interventional, and Treatment

From the registry’s dates

  • Started Jan 2025; still recruiting 1 year 8 months later.
Phase
Phase 2
Study type
Interventional
Enrollment
28
Allocation
Not applicable
Ages
19 Years to 80 Years
Sex
All
01

Study 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 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.

02

Conditions studied

  • T Lymphoblastic Leukemia/Lymphoma

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Keywords

  • T lymphoblastic leukemia/lymphoma
  • venetoclax
  • decitabine
03

In context

Lymphoma

5,578 studies on the registry are indexed under Lymphoma; 825 are open to participants now.

This study's planned enrollment of 28 is below the median of 40 across 4,508 interventional studies indexed under Lymphoma.

Browse Lymphoma studies →

Lead sponsor

Seoul National University Hospital is the lead sponsor of 1,860 studies on the registry; 275 are open to participants now.

Of its 12 completed or terminated interventional studies of FDA-regulated products, 2 (17%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
19 Years to 80 Years
Sexes eligible
All
Accepts healthy volunteers
No

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

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.
05

Study design

Phase
Phase 2
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
28 participants (estimated)

Study arms

  • Experimental
    decitabine and venetoclax arm

    arm treated with venetoclax plus decitabine

    Drug: decitabine plus venetoclax

Interventions

  • Drugdecitabine plus venetoclax

    decitabine 20mg/m2 for 7 days venetoclax 400mg daily for 21 days

06

What researchers measure

Primary outcomes

  1. 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

    Time frame: 1 year

Secondary outcomes

  1. Composite overall response rate

    cORR: CR/CRh/CRi/MLFS+PR

    Time frame: 1 year

  2. 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

    Time frame: 1 year

  3. Duration of response

    by months

    Time frame: 1 year

  4. Bridging to allogeneic hematopoietic stem cell transplantation (HSCT)

    by rate

    Time frame: 1 year

  5. Progression-free survival (PFS)

    by months

    Time frame: 1 year

  6. Overall survival (OS)

    by months

    Time frame: 1 year

07

Study locations

1 of 3 sites recruiting
  • Seoul National University Bundang Hospital
    Seongnam-si, 13620, South Korea
    Not yet recruiting
  • Seoul National University Hospital
    Seoul, 03080, South Korea
    • Dong-Yeop Shin, MD, PhD · Contact · shindongyeop@snu.ac.kr · +82-2-2072-7209
    • Dong-Yeop Shin, MD, PhD · Principal investigator
    Not yet recruiting
  • Seoul National University Hospital
    Seoul, 03080, South Korea
    Recruiting
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Feb 2, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT06712121
Lead sponsor
Seoul National University Hospital
Collaborators
Korean Society of Hematology
Responsible party
Dong-Yeop Shin (Associate Professor, Seoul National University Hospital) — Principal investigator
First posted
Dec 2, 2024
Start date
Jan 30, 2025
Primary completion
Aug 31, 2027 (estimated)
Completion
Aug 31, 2028 (estimated)
Last update
Feb 2, 2026

Study contacts

Dong-Yeop Shin, MD, PhD.
Contact
shindongyeop@snu.ac.kr
82+220727209
EunHee Park, RN
Contact
epark@snuh.org

Oversight

Data monitoring committee
No
FDA-regulated drug
Yes
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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