A Phase 2 interventional study of Venetoclax and Azacitidine in Early T Acute Lymphoblastic Leukemia, T-Acute Lymphoblastic Leukemia and Mixed Phenotype Acute Leukemia, T/Myeloid, Nos, sponsored by yuejun Liu. Recruiting at 1 site in China. Open to participants aged 14 Years and older. Per ClinicalTrials.gov, last updated 2025-06-10.
Sponsored by yuejun Liu · Phase 2, Interventional, and Treatment
Among 17 studies testing venetoclax in Precursor T-Cell Lymphoblastic Leukemia-Lymphoma — 11 open to participants now, 13 under way, 1 of them phase 3. venetoclax · Precursor T-Cell Lymphoblastic Leukemia-Lymphoma.
Among the 17 studies testing venetoclax in Precursor T-Cell Lymphoblastic Leukemia-Lymphoma, this one is the 8th largest by planned enrollment, is one of 6 that started in 2025, is one of 9 in phase 2, reaches primary completion later than 3 of the 12 other live ones, and was the 14th registered.
420 studies on the registry are indexed under Precursor T-Cell Lymphoblastic Leukemia-Lymphoma; 76 are open to participants now.
Browse Precursor T-Cell Lymphoblastic Leukemia-Lymphoma studies →11 of the 17 studies testing venetoclax in Precursor T-Cell Lymphoblastic Leukemia-Lymphoma are open now, in 12 countries. Recruiting first, the newest first:
M.D. Anderson Cancer Center · Sites in United States
Princess Maxima Center for Pediatric Oncology · Sites in Austria, Belgium, Denmark and 11 more countries
Princess Maxima Center for Pediatric Oncology · Sites in Austria, Belgium, Denmark and 11 more countries
M.D. Anderson Cancer Center · Sites in United States
The First Affiliated Hospital of Soochow University · Sites in China
By country, each count listing its studies:
venetoclax: first FDA approval 2016 (VENCLEXTA), first EMA approval 2016. What it is approved for, and how studies give it, is on its page →
Of the 60 Precursor T-Cell Lymphoblastic Leukemia-Lymphoma studies recruiting now, 24 (40%) set no upper age limit and 31 (52%) stop at 75 or younger; 36 take children under 18; 1 take healthy volunteers.
This study: 14 Years and older · all sexes · no healthy volunteers.
The full table on the hub →This tab as a report to print or save as PDF → With an account.
17 studies; the count open now beside each. This study's row is marked.
A study in two phases is counted once above. Listed by phase, each with its combined phases: Phase 1 7 · Phase 2 16 · Phase 3 1
First in 2018; this study’s year is marked. 6 started in 2025.
This study's planned enrollment of 32 is close to the median of 30 across 322 interventional studies indexed under Precursor T-Cell Lymphoblastic Leukemia-Lymphoma.
Median enrollment 28 across the 17 interventional studies. Of the 2 that completed or were terminated, 0 (0%) have results posted.
This tab as a report to print or save as PDF → With an account.
None of the 17 has an industry lead sponsor. The 9 most frequent:
This is the only study on the registry with yuejun Liu as lead sponsor.
yuejun Liu has 1 study filed under Precursor T-Cell Lymphoblastic Leukemia-Lymphoma — fewer than ten, so there is no comparison to draw.
4 of the studies testing venetoclax in Precursor T-Cell Lymphoblastic Leukemia-Lymphoma that are under way reach primary completion within a year, 0 of them phase 3. Phase 3 first, then by date:
| Study | Primary completion |
|---|---|
| NCT05376111The First Affiliated Hospital of Soochow UniversityStudy of Venetoclax Combined With Azacitidine Regimen in Newly Diagnosed T-ALL Patients | 2026-12-01 |
| NCT04128501M.D. Anderson Cancer CenterVenetoclax and Azacitidine for the Treatment of Acute Myeloid Leukemia in the Post-Transplant Setting | 2026-12-31 |
| NCT07012447yuejun LiuVenetoclax + Azacytidine for Newly Diagnosed ETP-like ALL and T-ALL With Myeloid Mutations | 2027-04-01 |
| NCT06686108Shanghai General Hospital, Shanghai Jiao Tong University School of MedicineDemethylating Agents Combined With Venetoclax for High-risk T-cell Lymphoblastic Lymphoma/Leukemia Post-Transplant Relapse Prevention | 2027-10-30 |
Among the 17 studies testing venetoclax in Precursor T-Cell Lymphoblastic Leukemia-Lymphoma, from their registry updates:
Nothing recorded among them since 2026-09-25.
This tab as a report to print or save as PDF → With an account.
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.
The main question it aims to answer: Does venetoclax plus azacitidine achieve a significantly higher overall response rate (ORR: CR + CRi) compared to historical controls (54% vs. 90%) after two induction cycles?
Comparison group: Researchers will compare ORR outcomes to historical data from conventional chemotherapy regimens to assess treatment superiority.
Participants will:
This study addresses the unmet need for effective therapies in high-risk T-ALL subtypes, including ETP-like leukemia and T/My-MPAL, which exhibit myeloid-like genetic profiles (e.g., FLT3, DNMT3A, RUNX1 mutations) and poor outcomes under conventional chemotherapy (5-year OS \<40%). Preclinical and pilot clinical data demonstrate that venetoclax, a BCL-2 inhibitor, synergizes with azacitidine, a hypomethylating agent, to induce apoptosis in leukemia stem cells by targeting oxidative phosphorylation and epigenetic dysregulation. Building on a pilot study, this Phase II trial employs a single-arm design to validate efficacy in a larger cohort.
Patients receive two induction cycles of venetoclax (oral, 100 mg D1, 200 mg D2, 400 mg D3-28) and azacitidine (75 mg/m² SC D1-7), with response assessed via bone marrow morphology, flow cytometry, and molecular testing (Days 22-35).
Early Efficacy Evaluation: After the first induction cycle (Days 22-35), response is assessed via bone marrow morphology, flow cytometry, and molecular profiling.
Stopping Criteria:
Patients failing to achieve at least partial remission (PR) after Cycle 1 will be withdrawn from the study.
Patients failing to achieve CR or CRi at the end of Cycle 2 will also discontinue study treatment.
Consolidation strategies include allo-HSCT or high dose cytarabine (HiDAC) for fit patients or maintenance therapy for unfit individuals.
Rigorous safety monitoring follows NCI-CTCAE v5.0 criteria, with dose adjustments for hematologic/non-hematologic toxicities.
Statistical analysis includes intent-to-treat and per-protocol populations, with ORR analyzed via exact binomial tests and survival endpoints via Kaplan-Meier/Cox regression. The study integrates translational biomarkers (e.g., BCL-2 expression, mutational profiling) to identify predictors of response, aiming to establish a novel, mechanism-driven regimen for these aggressive leukemias.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
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 (including FLT3, DNMT3A, STAG2, IDH1/2, RUNX1, EZH2, WT1, ASXL1/2, SF3B1, TET2, BCOR, BCORL1, and MLL-PTD) T/myeloid mixed phenotype acute leukemia (T/My-MPAL) (with concurrent T-lineage and myeloid markers, e.g., cCD3⁺/mCD3⁺, CD7⁺, MPO⁺)
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
A yellow substance made when red blood cells are broken down, which the liver clears. A high level can mean a problem with the liver or the bile ducts.
Criteria often allow more for people with Gilbert’s syndrome, a harmless inherited condition that raises bilirubin.
The top of the normal range for a blood test, as set by the laboratory that runs it. Each lab prints its own range next to your result.
“≤ 2.5 × ULN” means the result can be up to two and a half times that top value.
Two enzymes measured in a routine blood test of the liver. Higher levels can mean the liver is under strain or damaged. SGPT and SGOT are older names for ALT and AST.
Criteria usually give a limit as a multiple of the upper limit of normal (ULN), often higher when cancer has spread to the liver.
How quickly the kidneys clear creatinine, a waste product, from the blood. A study may estimate it from a blood test with age, weight and sex (often by the Cockcroft–Gault formula), or measure it using blood and urine collected over a set time. Given in mL/min; higher is better.
The share of blood the heart’s main pumping chamber (the left ventricle) pushes out with each beat, measured by an echocardiogram (heart ultrasound) or a MUGA scan. About 50–70% is normal.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
Able to become pregnant: from the first period until menopause, unless permanently unable to through surgery (removal of the womb, or of both ovaries or both fallopian tubes).
Criteria for people of childbearing potential usually ask for a negative pregnancy test and for contraception during the study and for a time after it.
Bilirubin
A yellow substance made when red blood cells are broken down, which the liver clears. A high level can mean a problem with the liver or the bile ducts.
Criteria often allow more for people with Gilbert’s syndrome, a harmless inherited condition that raises bilirubin.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
ULN (upper limit of normal)
The top of the normal range for a blood test, as set by the laboratory that runs it. Each lab prints its own range next to your result.
“≤ 2.5 × ULN” means the result can be up to two and a half times that top value.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
ALT and AST (liver enzymes)
Two enzymes measured in a routine blood test of the liver. Higher levels can mean the liver is under strain or damaged. SGPT and SGOT are older names for ALT and AST.
Criteria usually give a limit as a multiple of the upper limit of normal (ULN), often higher when cancer has spread to the liver.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Creatinine clearance (CrCl)
How quickly the kidneys clear creatinine, a waste product, from the blood. A study may estimate it from a blood test with age, weight and sex (often by the Cockcroft–Gault formula), or measure it using blood and urine collected over a set time. Given in mL/min; higher is better.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
LVEF (left ventricular ejection fraction)
The share of blood the heart’s main pumping chamber (the left ventricle) pushes out with each beat, measured by an echocardiogram (heart ultrasound) or a MUGA scan. About 50–70% is normal.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hypersensitivity
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraception
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Childbearing potential
Able to become pregnant: from the first period until menopause, unless permanently unable to through surgery (removal of the womb, or of both ovaries or both fallopian tubes).
Criteria for people of childbearing potential usually ask for a negative pregnancy test and for contraception during the study and for a time after it.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Two cycles induction as venetoclax (oral, 100 mg D1, 200 mg D2, 400 mg D3-28) and azacitidine (75 mg/m² SC D1-7); Consolidation: For fit patients, if those with MRD (Minimal Residual Disease) are negative or refuse to undergo allo-HSCT (Hematopoietic stem-cell transplantation), intermediate-dose (2g/m² q12h, days 1-3) cytarabine-based therapy is administered for 3-4 cycles; if patients are MRD-positive, they undergo allo-HSCT. For unfit patients, each venetoclax combined with azacitidine treatment cycle is anticipated to be 28 days in length until progression of disease, although cycle delays may occur due to delayed blood count recovery.
Drug: Venetoclax · Drug: Azacitidine · Drug: Cytarabine
Orally by mouth
Also known as: Venclexta
Subcutaneous injection
Intravenous infusion
Also known as: Ara-C
Overall response rate (ORR) after two treatment cycles of induction therapy
Rates of complete remission (CR), and complete remission with incomplete hematologic recovery (CRi)
Time frame: time from the date of enrollment to 2 cycles of induction before consolidation therapy（100 days）
OS: overall survival
time from the date of enrollment to death from any cause or the last follow-up
Time frame: 2 years
LFS：leukemia-free survival
the duration from the date of enrollment to the occurrence of treatment failure, relapse, death from any cause, or the last follow-up.
Time frame: 2 years
DOR: duration of remission
Time between the first remission and relapse
Time frame: 2 years
AE
Adverse events during the induction treatment.
Time frame: Within 60 days after treatment
Volume of infused blood products
The volume of infused blood products during the induction treatment.
Time frame: Within 60 days
Plan to share: No
No publications or documents are linked to this record.
Started Apr 2025 (actual). Primary completion is estimated for Apr 2027, 24 months after the start.
Of 41 non-industry phase 2 interventional studies under Precursor T-Cell Lymphoblastic Leukemia-Lymphoma, half reached primary completion within 64 months of starting (the median), counting those still running; a quarter within 43 and three quarters within 97. This study's planned 24 months is below that.
Counting every sponsor, half of 44 studies reached it within 63 months; a quarter within 39 and three quarters within 97.
How these figures are worked out, and which studies are left out of them.
Eligibility is decided by the study team. Share this record with your doctor or contact the team directly.
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Studies of the drugs tested here: Venetoclax · Azacitidine
Precursor T-Cell Lymphoblastic Leukemia-Lymphoma →