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New treatment option for Adult T-cell Leukemia/Lymphoma
Official title Venetoclax Combined With Azacitidine, Chidamide, Vindesine, and Dexamethasone in Newly Diagnosed ETP-ALL Like Patients
ClinicalTrials.gov ID: NCT07159620
What this study is testing
What is VEN (Venetoclax)?
VEN (Venetoclax) is an investigational medicine, given as a pill taken by mouth, being studied as a potential treatment for adult t-cell 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
- ETP-ALL like patients have poor outcomes and prognosis, and the optimal therapeutic approaches are poorly characterized. The goal of this clinical trial is to evaluate the efficacy and safety of the venetoclax combined with azacitidine, chidamide, vindesine, and dexamethasone regimen in newly diagnosed ETP-ALL like patinets (including ETP-ALL, near ETP-ALL and T-ALL with myeloid mutations) .
- 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 14 to 65
You may be able to join if
- Age: \>14 to 65 years (inclusive).
- Diagnosis: Patients diagnosed with ETP-ALL like disease meeting the following flow cytometry immunophenotypic criteria: ETP-ALL: CD7+, CD1a-, CD8-...
- Newly diagnosed patients who have not received any prior induction therapy before enrollment (excluding hydroxyurea, dexamethasone, low-dose...
- Eastern Cooperative Oncology Group (ECOG) performance status score of 0-2.
- Expected survival \>6 months.
You likely can't join if
- Pregnancy, breastfeeding, or unwillingness to use contraception in women of childbearing potential
- Presence of uncontrolled active infection (including bacterial, fungal, or viral infections); concurrent active HBV, HCV, or HIV infection.
- Severe Organ Dysfunction: Cardiac Insufficiency: Left ventricular ejection fraction (LVEF) ≤40%, OR history of congestive heart failure, unstable...
- Presence of central nervous system (CNS) leukemia.
- Any other condition deemed by the investigator to make the subject unsuitable for participation in this trial.
See the full eligibility criteria
- Age: \>14 to 65 years (inclusive).
- Diagnosis: Patients diagnosed with ETP-ALL like disease meeting the following flow cytometry immunophenotypic criteria: ETP-ALL: CD7+, CD1a-, CD8-, CD5 positivity rate ≤75%, and positive for at least one myeloid/stem...
- Newly diagnosed patients who have not received any prior induction therapy before enrollment (excluding hydroxyurea, dexamethasone, low-dose cytarabine, venetoclax with a cumulative dose \<0.5g, and leukapheresis).
- Eastern Cooperative Oncology Group (ECOG) performance status score of 0-2.
- Expected survival \>6 months.
- Demonstrated capacity to understand the study and willingness to provide informed consent.
- Pregnancy, breastfeeding, or unwillingness to use contraception in women of childbearing potential
- Presence of uncontrolled active infection (including bacterial, fungal, or viral infections); concurrent active HBV, HCV, or HIV infection.
- Severe Organ Dysfunction: Cardiac Insufficiency: Left ventricular ejection fraction (LVEF) ≤40%, OR history of congestive heart failure, unstable coronary artery disease, or severe arrhythmia. Respiratory Failure...
- Presence of central nervous system (CNS) leukemia.
- Any other condition deemed by the investigator to make the subject unsuitable for participation in this trial.
The study team makes the final eligibility decision.
Where it's taking place
- Suzhou, Jiangsu, China
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, 14 years to 65 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Suzhou, Jiangsu, China. 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.