Sensitivity and Specificity of Cytokines in the Diagnosis of Lymphoma-associated HLH

Lymphoma Clinical Trial

Official title:

The Role of Cytokines in Early Diagnosis, Assessment of Response and Prognosis of Patients With Lymphoma-associated Hemophagocytic Lymphohistiocytosis

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT05600959
• Other study ID #: BFH20221009001/BFHHZML20220006
• Status: Not yet recruiting
• Start date: November 1, 2022
• Est. completion date: December 31, 2025

Study information

• Verified date: October 2022
• Source: Beijing Friendship Hospital
• Contact: Zhao Wang
• Phone: 63138303
• Email: wangzhao[@]ccmu.edu.cn
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial Summary

Lymphoma-associated hemophagocytic lympohistiocytosis is a refractory immune disorder with high mortality. Early identification and diagnosis of lymphoma-associated HLH has become the key to improve the prognosis of lymphoma-associated HLH. Therefore, we conduct a multicenter, prospective, observational clinical study to explore the sensitivity and specificity of cytokines for the early diagnosis of lymphoma-associated HLH.

Description:

Lymphoma-associated hemophagocytic lympohistiocytosis is a refractory immune disorder with high mortality. Without early intervention, the median survival time is less than 2 months. Early identification and diagnosis of lymphoma-associated HLH has become the key to improve the prognosis of lymphoma-associated HLH. Therefore, it is urgent to find a method for the early diagnosis of lymphoma-associated HLH. We conduct a multicenter, prospective, observational clinical study to explore the sensitivity and specificity of cytokines for the early diagnosis of lymphoma-associated HLH, and its correlation with disease severity, treatment response, and prognosis.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 60
• Est. completion date: December 31, 2025
• Est. primary completion date: November 1, 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

Inclusion Criteria:

• Age 40-75, gender is not limited.
• Patients with histopathologically confirmed lymphoma who meet HLH-04 diagnostic criteria, and did not receive systemic chemotherapy before enrollment.
• Patients with histopathologically confirmed lymphoma who did not receive systemic chemotherapy before enrollment.
• Informed consent obtained.

Exclusion Criteria:

• Patients with severe active infections (viral, bacterial, fungal, or parasitic).
• Patients with active autoimmune disease or a history of organ transplantation who are receiving immunosuppressive therapy.
• Patients with other type of malignant tumors within 5 years, except for cured solid tumors.
• Patients planned to receive immunotherapy.
• Pregnant and breastfeeding females.
• History of human immunodeficiency virus (HIV) infection.
• Acute or chronic active hepatitis B or hepatitis C.
• Patients assessed as ineligible for the study by the investigator.

Related Conditions & MeSH terms

• Hemophagocytic Lymphohistiocytoses
• Lymphohistiocytosis, Hemophagocytic
• Lymphoma

Intervention

Diagnostic Test:
• cytokine
Peripheral blood samples were collected at diagnosis, 2 weeks after the first cycle of chemotherapy and 2 weeks after the second cycle of chemotherapy to monitor cytokine level changes.

Locations

Country	Name	City	State
China	Zhao Wang	Beijing	Beijing

Sponsors (1)

Lead Sponsor	Collaborator
Beijing Friendship Hospital

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The sensitivity and specificity of cytokines to predict lymphoma-associated HLH	The sensitivity and specificity of cytokines as a means of early diagnosis of lymphoma-associated hemophagocytic lymphohistiocytosis	1 year
Secondary	Dynamic changes of cytokine levels during treatment	To monitor the correlation between cytokine levels and disease severity, treatment response and prognosis of lymphoma-associated hemophagocytic lymphohistiocytosis	1 years