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

NCT07046182 | Active Not Recruiting Phase 4

• 1 other identifier: 2025-IIT-ZMZ/YJQ
• Study Type: interventional
• Target: 34
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Angioimmunoblastic T-cell Lymphoma (AITL)

Outcome Measures

Primary Outcomes (1)

• progression free survial

  3 years

Study Arms (1)

group1

EXPERIMENTAL

CEP + Dasatinib + Azacitidine

Biological: CEP + Dasatinib + Azacitidine

Interventions

CEP + Dasatinib + Azacitidine BIOLOGICAL

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

group1

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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 \[except for bone marrow infiltration\]).
• At least one measurable lesion (lymph node: long diameter ≥1.5 cm, short diameter ≥1.0 cm; extranodal: long diameter ≥1.0 cm).
• Liver function: TBIL ≤1.5×ULN, ALT/AST ≤2.5×ULN, ALP ≤3×ULN (non-bone infiltration).
• 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).
• Informed consent and compliance with follow-up. 11.No concurrent anti-tumor therapies (e.g., traditional Chinese medicine, immunotherapy, biological agents).

You may not qualify if:

• 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

Sponsors & Collaborators

• Zhengzhou University: lead

Study Sites (1)

The First Affiliated Hospital of Zhengzhou University

Zhengzhou, Henan, 450052, China

Location

MeSH Terms

Conditions

Immunoblastic Lymphadenopathy

Interventions

Dasatinib; Azacitidine

Condition Hierarchy (Ancestors)

Lymphadenopathy; Lymphatic Diseases; Hemic and Lymphatic Diseases; Lymphoproliferative Disorders; Immunoproliferative Disorders; Immune System Diseases

Intervention Hierarchy (Ancestors)

Thiazoles; Sulfur Compounds; Organic Chemicals; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Pyrimidines; Aza Compounds; Cytidine; Pyrimidine Nucleosides; Nucleosides; Nucleic Acids, Nucleotides, and Nucleosides; Ribonucleosides

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: professor

Study Record Dates

• First Submitted: June 22, 2025
• First Posted: July 1, 2025
• Study Start: October 21, 2023
• Primary Completion (Estimated): May 26, 2028
• Study Completion (Estimated): May 26, 2028
• Last Updated: July 1, 2025

Record last verified: 2025-06

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)