Venetoclax and Decitabine in R/R T-ALL

NCT06712121 | Recruiting Phase 2 FDA Drug

• 1 other identifier: VEDETTE
• Study Type: interventional
• Target: 28
• Locations: 1 country
• Sites: 3

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.

Conditions

T Lymphoblastic Leukemia/Lymphoma

Keywords

T lymphoblastic leukemia/lymphoma; venetoclax; decitabine

Outcome Measures

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

  1 year

Secondary Outcomes (6)

• Composite overall response rate

  1 year

• Clinical benefit rate

  1 year

• Duration of response

  1 year

• Bridging to allogeneic hematopoietic stem cell transplantation (HSCT)

  1 year

• Progression-free survival (PFS)

  1 year

Study Arms (1)

decitabine and venetoclax arm

EXPERIMENTAL

arm treated with venetoclax plus decitabine

Drug: decitabine plus venetoclax

Interventions

decitabine plus venetoclax DRUG

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

decitabine and venetoclax arm

Eligibility Criteria

• Age: 19 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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:

You may not qualify if:

• 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.

Sponsors & Collaborators

• Korean Society of Hematology: collaborator
• Seoul National University Hospital: lead

Study Sites (3)

Seoul National University Bundang Hospital

Seongnam-si, 13620, South Korea

NOT YET RECRUITING

Seoul National University Hospital

Seoul, 03080, South Korea

NOT YET RECRUITING

Seoul National University Hospital

Seoul, 03080, South Korea

RECRUITING

MeSH Terms

Conditions

Lymphoma

Interventions

Decitabine; venetoclax

Condition Hierarchy (Ancestors)

Neoplasms by Histologic Type; Neoplasms; Lymphoproliferative Disorders; Lymphatic Diseases; Hemic and Lymphatic Diseases; Immunoproliferative Disorders; Immune System Diseases

Intervention Hierarchy (Ancestors)

Azacitidine; Aza Compounds; Organic Chemicals; Cytidine; Pyrimidine Nucleosides; Pyrimidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Nucleosides; Nucleic Acids, Nucleotides, and Nucleosides; Ribonucleosides

Central Study Contacts

Dong-Yeop Shin, MD, PhD.

CONTACT

82+220727209; shindongyeop@snu.ac.kr

EunHee Park, RN

CONTACT

epark@snuh.org

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Study Record Dates

• First Submitted: November 26, 2024
• First Posted: December 2, 2024
• Study Start: January 30, 2025
• Primary Completion (Estimated): August 31, 2027
• Study Completion (Estimated): August 31, 2028
• Last Updated: February 2, 2026

Record last verified: 2026-01

Data Sharing

• IPD Sharing: Will not share

Locations

KR (3)