Skip to main content
OpenTrials
Active, Not Recruiting

NCT Number: NCT07046182

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

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

Active, Not Recruiting

This study is active but is not currently recruiting participants.

Notify Me

Key information

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

The First Affiliated Hospital of Zhengzhou University

Zhengzhou, Henan, 450052, China

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

CEP + Dasatinib + Azacitidine

Biological

CEP + Dasatinib + Azacitidine as the first-line treatment regimen for patients with Angioimmunoblastic T-cell Lymphoma

Primary outcomes

  1. progression free survial

    Time frame: 3 years

Sponsors and collaborators

Lead sponsor

Zhengzhou University

Other

Registry information

Important dates

Study start
2023
Primary completion
2028
Study completion
2028
First posted
Jul 1, 2025
Registry last updated
Jul 1, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.