Venetoclax and Decitabine in R/R T-ALL

January 29, 2026 updated by: Dong-Yeop Shin, Seoul National University Hospital

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Estimated)

28

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • South Korea
      • Seongnam-si, South Korea, 13620
        • Not yet recruiting
        • Seoul National University Bundang Hospital
        • Contact:
      • Seoul, South Korea, 03080
        • Not yet recruiting
        • Seoul National University Hospital
        • Principal Investigator:
          • Dong-Yeop Shin, MD, PhD
        • Contact:
      • Seoul, South Korea, 03080
        • Recruiting
        • Seoul National University Hospital
        • Contact:
        • Contact:
        • Principal Investigator:
          • Dong-Yeop Shin

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: decitabine and venetoclax arm
arm treated with venetoclax plus decitabine
Drug: decitabine plus venetoclax
decitabine 20mg/m2 for 7 days venetoclax 400mg daily for 21 days

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
1 year

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Composite overall response rate
Time Frame: 1 year
cORR: CR/CRh/CRi/MLFS+PR
1 year
Duration of response
Time Frame: 1 year
by months
1 year
Bridging to allogeneic hematopoietic stem cell transplantation (HSCT)
Time Frame: 1 year
by rate
1 year
Progression-free survival (PFS)
Time Frame: 1 year
by months
1 year
Overall survival (OS)
Time Frame: 1 year
by months
1 year
Clinical benefit rate
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 PR: partial remission stable disease
1 year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Seoul National University Hospital

Collaborators

Korean Society of Hematology

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 30, 2025

Primary Completion (Estimated)

August 31, 2027

Study Completion (Estimated)

August 31, 2028

Study Registration Dates

First Submitted

November 26, 2024

First Submitted That Met QC Criteria

November 26, 2024

First Posted (Actual)

December 2, 2024

Study Record Updates

Last Update Posted (Actual)

February 2, 2026

Last Update Submitted That Met QC Criteria

January 29, 2026

Last Verified

January 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • VEDETTE

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

Yes

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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