NCT07541755Active, not recruitingPhase 3
PD-1 Inhibitors +Venetoclax+CAG Regimens in R/R T-ALL
A Prospective, Multicenter Clinical Study on the Efficacy and Safety of PD-1 Inhibitors Combined With Venetoclax+CAG Regimens in the Treatment of Adult Refractory/Relapsed Acute T-lymphoblastic Leukemia (T-ALL)
Source: ClinicalTrials.gov · Last updated 21 Apr 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Active, not recruiting
- Phase (registry)
- Phase 3
- Study type
- Interventional
- Enrollment
- 40 (estimated)
- First submitted
- 15 Jan 2026
- Start date
- 1 May 2025
- Primary completion date
- 31 Jan 2027
- Lead sponsor
- Fujian Medical University Union Hospital
- Diseases
- Acute lymphoblastic leukaemia
- NCT number
- NCT07541755
What you commit to
- Study type: Interventional · Phase 3
- Planned participants: 40
- From 1 May 2025 to the primary completion date, 31 Jan 2027
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Other illness
- 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;
- 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;
Age
- Patients under 18 years old.
Other
- Inability to understand or comply with the research protocol;
Who the study is looking for
- 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.
Age in the registry: 18 years to 70 years · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Fujian Medical University Union Hospital Coordinator of this site? Confirm its status | Fuzhou | China | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.