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New treatment option for T Lymphoblastic Leukemia/Lymphoma
Official title Venetoclax and Decitabine in R/R T-ALL
ClinicalTrials.gov ID: NCT06712121
What this study is testing
What is decitabine plus venetoclax?
decitabine plus venetoclax is an investigational medicine, given as an once-daily, being studied as a potential treatment for t lymphoblastic leukemia/lymphoma.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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.
- Phase 2: a mid-size study of how well it works
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 19 to 80
You may be able to join 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...
- Patients with peripheral blood leukocytes \<50,000/uL (reducing white blood cell count through hydroxyurea or leukapheresis prior to trial enrollment...
- At the time of screening, a calculated glomerular filtration rate (GFR) ≥ 30 mL/min according to the Cockcroft-Gault formulas, or creatinine ≤ 1.4...
You likely can't join if
- Individuals in complete remission with previous treatment, if relapse or resistance is not confirmed by bone marrow examination or imaging/tissue...
- Individuals who previously received venetoclax + decitabine treatment for T-lymphoblastic leukemia/lymphoma (participants who received venetoclax +...
- 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...
See the full eligibility 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...
- Individuals who agree to the following contraceptive measures for a period of 3 months during treatment and for 3 months after completion:
- 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...
- 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...
- 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...
- 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.
The study team makes the final eligibility decision.
Where it's taking place
- Seongnam-si, South Korea
- Seoul, South Korea
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 19 years to 80 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Seongnam-si, South Korea; Seoul, South Korea. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.