Clinical Study of CEP+Dasatinib + Azacytidine in First-line Treatment of. Angioimmunoblastoma Foresight

NCT07046182•Zhengzhou University

Summary

To observe the efficacy and safety of the CEP + Dasatinib + Azacitidine as the first-line treatment regimen for patients with Angioimmunoblastic T-cell Lymphoma.

Eligibility

Age

18 - 75 years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•1.Age 18-75 years, ECOG 0-2. 2.Life expectancy \>6 months. 3.Pathologically confirmed AITL. 4.Acceptable hematological parameters (neutrophils ≥1.0×10⁹/L, platelets ≥75×10⁹/L, hemoglobin ≥80 g/L \[except for bone marrow infiltration\]).
•5.At least one measurable lesion (lymph node: long diameter ≥1.5 cm, short diameter ≥1.0 cm; extranodal: long diameter ≥1.0 cm).
•6.Liver function: TBIL ≤1.5×ULN, ALT/AST ≤2.5×ULN, ALP ≤3×ULN (non-bone infiltration).
•7.Renal function: serum creatinine ≤1.5×ULN. 8.No severe comorbidities; normal cardiac function. 9.Willingness to use contraception; negative pregnancy test for育龄期女性 (within 7 days prior to first dose).
•10.Informed consent and compliance with follow-up. 11.No concurrent anti-tumor therapies (e.g., traditional Chinese medicine, immunotherapy, biological agents).

Exclusion Criteria

•\- 1.Patients with definite neurological or psychiatric diseases, including dementia or epilepsy, with a history of psychotropic drug abuse and inability to quit, or other substantive lesions that may increase central neurotoxicity; 2.Those who are participating in other clinical trials or have participated in other clinical research within the previous 4 weeks (except those who have not received treatment); 3.Systemic autoimmune diseases or immunodeficiency; 4.Refusal to provide blood samples; 5.Allergic to any drug in the plan; 6.Pregnant and lactating women; 7.Subjects with significant diseases that may interfere with the trial and with uncontrolled active infections; 8.Primary or relapsed central nervous system tumors; 9.Contraindications for chemotherapy; 10.Researchers believe that they are not suitable for inclusion; 11.Any active bacterial, viral, fungal, mycobacterial, parasitic or other infections (excluding superficial skin or mucosal infections) or any major systemic infectious diseases (septicemia, etc.) that require antibiotic treatment or hospitalization within the previous 4 weeks before inclusion; 12.Those who have received anti - tumor treatment (such as radiotherapy, chemotherapy, immunotherapy, biotherapy, immunotherapy); 13.Other severe conditions that may prevent the subject from participating in this trial, such as uncontrolled diabetes: Severe cardiac insufficiency (NYHA grade III or above); Acute coronary syndrome occurred within the previous 6 months; Coronary artery bypass grafting or stent implantation, mitral valve surgery, and other heart and major vascular - related surgeries within the previous 6 months; Severe arrhythmias including bradycardia, tachycardia, fast atrial fibrillation, atrial flutter, uncontrolled severe hypertension (systolic pressure ≥ 180 mmHg, diastolic pressure ≥ 110 mmHg), peptic ulcer disease (subjects judged to have a perforated peptic ulcer); Active autoimmune diseases (such as systemic lupus erythematosus, rheumatoid arthritis, polymyositis, scleroderma, autoimmune hemolytic anemia, etc.); Severe respiratory system diseases (such as bronchial asthma and pulmonary emphysema, etc.).
•14.Thrombocytopenic purpura patients; 15.Patients with positive hepatitis B surface antigen (HBsAg) or hepatitis B core antibody (HBcAb) and whose peripheral blood hepatitis B virus (HBV) DNA titer is not within the normal reference range; patients with positive hepatitis C virus (HCV) antibody and whose peripheral blood hepatitis C virus (HCV) RNA is positive; patients with positive human immunodeficiency virus (HIV) antibody; patients with positive cytomegalovirus (CMV) DNA test; patients with positive syphilis test

Locations (1)

The First Affiliated Hospital of Zhengzhou University

Zhengzhou, Henan, China

Key Dates

Start Date

October 21, 2023

Primary Completion Date

May 26, 2028

Completion Date

May 26, 2028

Last Updated

July 1, 2025

Enrollment

ACTUAL participants

Conditions

Angioimmunoblastic T-cell Lymphoma (AITL)

Interventions

CEP + Dasatinib + Azacitidine

BIOLOGICAL

Ro Plus CHOEP as First Line Treatment Before HSCT in Young Patients With Nodal Peripheral T-cell Lymphomas

NCT02223208

Peripheral T-cell Lymphomas (PTCL)PTCL-NOS+3 more

View study

Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: July 1, 2025Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

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