Hemophagocytic Lymphohistiocytoses, Lymphoma
Conditions
Keywords
Hemophagocytic Lymphohistiocytosis, Lymphoma, Cytokine, Diagnosis
Brief 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.
Detailed 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.
Interventions
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.
Sponsors
Study design
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| The sensitivity and specificity of cytokines to predict lymphoma-associated HLH | 1 year | The sensitivity and specificity of cytokines as a means of early diagnosis of lymphoma-associated hemophagocytic lymphohistiocytosis |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Dynamic changes of cytokine levels during treatment | 1 years | To monitor the correlation between cytokine levels and disease severity, treatment response and prognosis of lymphoma-associated hemophagocytic lymphohistiocytosis |
Countries
China