PD-1 Inhibitors +Venetoclax+CAG Regimens in R/R T-ALL

NCT07541755 | Active Not Recruiting Phase 3 DMC

• 1 other identifier: FujianUnionH-XYK2025
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Acute T Lymphoblastic Leukemia (T-ALL)

Keywords

acute T-lymphoblastic leukemia; PD-1 inhibitor; CAG; venetoclax

Outcome Measures

Primary Outcomes (1)

• mCRc

  CR+CRi+MLFS

  At the end of Cycle 2 (each cycle is 21 days)

Secondary Outcomes (3)

• Overall survival

  After 2 years

• Side effect

  At the end of every Cycle (each cycle is 21 days)

• minimal residual disease, MRD

  At the end of every Cycle (each cycle is 21 days)

Study Arms (1)

PD-1+venetoclax+CAG treatment group

EXPERIMENTAL

PD-1 inhibitor combined with venetoclax and CAG regimen (cytarabine, aclarubicin, G-CSF) for up to 2 cycles of 21 days each in patients with relapsed/refractory T-ALL.

Drug: PD-1 Inhibitors

Interventions

PD-1 Inhibitors DRUG

PD-1 inhibitor+venetoclax+Cytarabine+Aclarubicin+G-CSF regimen

Also known as: venetocalx, Aclarubicin, Cytarabine, G-CSF

PD-1+venetoclax+CAG treatment group

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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;
• Inability to understand or comply with the research protocol;
• Patients under 18 years old.

Sponsors & Collaborators

• Fujian Medical University Union Hospital: lead

Study Sites (1)

Fujian Medical University Union Hospital

Fuzhou, Fujian, 350001, China

Location

MeSH Terms

Conditions

Precursor T-Cell Lymphoblastic Leukemia-Lymphoma

Interventions

Immune Checkpoint Inhibitors; Aclarubicin; Cytarabine; Granulocyte Colony-Stimulating Factor

Condition Hierarchy (Ancestors)

Precursor Cell Lymphoblastic Leukemia-Lymphoma; Leukemia, Lymphoid; Leukemia; Neoplasms by Histologic Type; Neoplasms; Hematologic Diseases; Hemic and Lymphatic Diseases; Lymphoproliferative Disorders; Lymphatic Diseases; Immunoproliferative Disorders; Immune System Diseases

Intervention Hierarchy (Ancestors)

Molecular Mechanisms of Pharmacological Action; Pharmacologic Actions; Chemical Actions and Uses; Antineoplastic Agents, Immunological; Antineoplastic Agents; Therapeutic Uses; Anthracyclines; Naphthacenes; Polycyclic Aromatic Hydrocarbons; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Polycyclic Compounds; Aminoglycosides; Glycosides; Carbohydrates; Cytidine; Pyrimidine Nucleosides; Pyrimidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Arabinonucleosides; Nucleosides; Nucleic Acids, Nucleotides, and Nucleosides; Colony-Stimulating Factors; Glycoproteins; Glycoconjugates; Hematopoietic Cell Growth Factors; Cytokines; Intercellular Signaling Peptides and Proteins; Peptides; Amino Acids, Peptides, and Proteins; Proteins; Biological Factors

Study Officials

• Shaoyuan Wang, Pro

  Fujian Institute of Hematology,Fujian Provincial Key Laboratory on Hematology,Fujian Medical University Union Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 15, 2026
• First Posted: April 21, 2026
• Study Start: May 1, 2025
• Primary Completion (Estimated): January 31, 2027
• Study Completion (Estimated): January 31, 2029
• Last Updated: April 21, 2026

Record last verified: 2025-05

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP
• Time Frame: Within 6 months after the publication of the main results.
• Access Criteria: Data will be accessible through two channels: (1) Publicly available in the "Results" section of ClinicalTrials.gov; (2) Upon reasonable request to the corresponding author. For channel (2), researchers must submit a research plan and data use agreement. Access is granted after approval by the ethics committee. Data use is restricted to non-commercial academic research. Users must not attempt to identify participants and must cite the source.

Locations

CN (1)