PD-1 Inhibitors +Venetoclax+CAG Regimens in R/R T-ALL
China40 participantsStarted 2025-05-01
Plain-language summary
This prospective multicenter study evaluates the efficacy and safety of PD-1 inhibitor combined with venetoclax and HAG/CAG chemotherapy in refractory/relapsed T-ALL (R/R T-ALL). Despite standard chemotherapy, R/R T-ALL remains challenging, with low salvage remission rates (\~40%) and poor survival. Preclinical data suggest PD-1 blockade enhances leukemic stem cell eradication, while venetoclax (BCL-2 inhibitor) synergizes with chemotherapy. Eligible patients receive 1-2 cycles of PD-1 inhibitor + venetoclax + CAG, with responders proceeding to allo-HSCT or MRD-guided consolidation. The trial aims to improve CR rates and survival, offering a novel immunochemotherapy approach for this high-risk population.
Who can participate
Age range18 Years – 70 Years
SexALL
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
✓. Age \>=18 years old;
✓. Met the T-ALL diagnosis before enrollment (for specific diagnostic criteria, see the attachment);
✓. Refractory T-ALL (newly diagnosed T-ALL that fails to achieve remission after treatment with one standard regimen) or recurrent T-ALL (bone marrow blasts exceed 5% again after remission, and the morphology and immunophenotype of leukemia cells are consistent with T-ALL);
✓. The performance status score of the Eastern Cooperative Oncology Group (ECOG) in the United States ranges from 0 to 2 points.
✓. Expected survival period \>=3 months;
✓. During the screening period, there were no organ function abnormalities that restricted the use of this scheme.
✓. Understand this study and sign the informed consent form.
Exclusion criteria
✕. Patients with refractory/relapsed T-ALL who are not suitable for or whose economic conditions restrict the use of PD-1 and venetoclax for treatment;
What they're measuring
1
mCRc
Timeframe: At the end of Cycle 2 (each cycle is 21 days)
. Diseases that may limit patients' participation in this trial due to abnormal functions of organs such as the heart, lungs, liver, and kidneys (such as advanced infections, uncontrolled diabetes, severe heart failure or angina pectoris, active pulmonary tuberculosis, asthma, COPD, bronchiectasis, severe renal insufficiency, etc.);
✕. There has been a history of other malignant tumors within the past five years;
✕. Known HIV infection, active hepatitis B virus (HbsAg positive and HBV-DNA higher than the upper limit of the detection value) or active hepatitis C virus (anti-HCV antibody positive or HCV RNA positive) infection;
✕. Inability to understand or comply with the research protocol;