Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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NOT_YET_RECRUITING
PHASE2
28 participants
INTERVENTIONAL
2025-01-30
2028-08-31
Brief Summary
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This study use a modified regimen of decitabine and venetoclax.
Detailed Description
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Conditions
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Keywords
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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decitabine and venetoclax arm
arm treated with venetoclax plus decitabine
decitabine plus venetoclax
decitabine 20mg/m2 for 7 days venetoclax 400mg daily for 21 days
Interventions
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decitabine plus venetoclax
decitabine 20mg/m2 for 7 days venetoclax 400mg daily for 21 days
Eligibility Criteria
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Inclusion Criteria
* 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 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.
19 Years
80 Years
ALL
No
Sponsors
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Korean Society of Hematology
NETWORK
Seoul National University Hospital
OTHER
Responsible Party
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Dong-Yeop Shin
Associate Professor
Locations
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Seoul National University Hospital
Seoul, , South Korea
Countries
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Central Contacts
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Facility Contacts
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Dong-Yeop Shin, MD, PhD
Role: primary
Other Identifiers
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VEDETTE
Identifier Type: -
Identifier Source: org_study_id