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

Capital Medical University

Status: Not yet enrolling

Conditions: Hemophagocytic Lymphohistiocytoses; Lymphoma

Treatments: Diagnostic Test: cytokine

Study type: Observational

Funder types: Other

Identifiers

NCT05600959

BFH20221009001/BFHHZML20220006

Details and patient eligibility

About

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.

Full 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.

Enrollment: 60 estimated patients

Sex: All

Ages: 18 to 65 years old

Volunteers: No Healthy Volunteers

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.

Trial design

60 participants in 2 patient groups

Lymphoma group

Description:

Patients with histopathologically confirmed lymphoma who did not receive systemic chemotherapy before enrollment.

Treatment:

Diagnostic Test: cytokine

Lymphoma-associated HLH group

Description:

Patients with histopathologically confirmed lymphoma who meet HLH-04 diagnostic criteria, and did not receive systemic chemotherapy before enrollment.

Treatment:

Diagnostic Test: cytokine