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New treatment option for Early T Acute Lymphoblastic Leukemia
Official title Venetoclax + Azacytidine for Newly Diagnosed ETP-like ALL and T-ALL With Myeloid Mutations
ClinicalTrials.gov ID: NCT07012447
What this study is testing
What is Venetoclax?
Venetoclax is an investigational medicine, given as an injection under the skin, being studied as a potential treatment for early t acute lymphoblastic leukemia.
Also referred to as Venclexta.
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 clinical trial is to evaluate the efficacy and safety of venetoclax combined with azacitidine in treating newly diagnosed early T-cell precursor (ETP)-like acute lymphoblastic leukemia (ALL), T-ALL with myeloid mutations, or T/myeloid mixed-phenotype acute leukemia (T/My-MPAL). Participant population: Patients aged ≥14 years diagnosed with ETP-like leukemia, T-ALL with myeloid mutations, or T/My-MPAL, regardless of sex/gender.
- 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 and older
You may be able to join if
- No gender restrictions
- Age ≥ 14 years
- Confirmed diagnosis of one of the following: ETP-like leukemia (CD7⁺, CD1a-, CD8-, with CD5 expression stratified as ETP-ALL ≤75% or Near-ETP-ALL...
- Newly diagnosed patients without prior induction therapy Limited prior therapy allowed: hydroxyurea, dexamethasone, or low-dose cytarabine/venetoclax...
- Expected survival time ≥ 3 months
You likely can't join if
- Presence of recurrent genetic abnormalities such as t(8;21), t(15;17), inv(16)/t(16;16) leukemia
- Prior hypersensitivity to study drugs or compounds of similar chemical structure
- Active uncontrolled infections as determined by the investigator
- Active bleeding
- Recent history (within 1 year) of thrombosis, embolism, or cerebral hemorrhage
- Pregnancy, breastfeeding, or unwillingness to use contraception in women of childbearing potential
See the full eligibility criteria
- No gender restrictions
- Age ≥ 14 years
- Confirmed diagnosis of one of the following: ETP-like leukemia (CD7⁺, CD1a-, CD8-, with CD5 expression stratified as ETP-ALL ≤75% or Near-ETP-ALL \>75%) T-cell acute lymphoblastic leukemia (T-ALL) with myeloid mutations...
- Newly diagnosed patients without prior induction therapy Limited prior therapy allowed: hydroxyurea, dexamethasone, or low-dose cytarabine/venetoclax (cumulative dose \<0.5g), and leukocytapheresis
- Expected survival time ≥ 3 months
- Liver function: total bilirubin ≤ 2× ULN; ALT/AST ≤ 3× ULN (or ≤ 5× ULN if liver infiltration by leukemia is present) ; Renal function: endogenous creatinine clearance ≥ 30 ml/min; Cardiac function: left ventricular...
- Demonstrated capacity to understand the study and willingness to provide informed consent
- Presence of recurrent genetic abnormalities such as t(8;21), t(15;17), inv(16)/t(16;16) leukemia
- Prior hypersensitivity to study drugs or compounds of similar chemical structure
- Active uncontrolled infections as determined by the investigator
- Active bleeding
- Recent history (within 1 year) of thrombosis, embolism, or cerebral hemorrhage
- Pregnancy, breastfeeding, or unwillingness to use contraception in women of childbearing potential
- Drug addiction or chronic alcoholism that could interfere with trial evaluation
- Psychiatric disorders or other conditions that would prevent obtaining informed consent or compliance with trial requirements
- Any condition deemed unsuitable for trial participation by the investigator
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 and older. 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.