Hemophagocytic LymphohistiocytosesNCT05600959
Sensitivity and Specificity of Cytokines in the Diagnosis of Lymphoma-associated HLH
An observational study of Hemophagocytic Lymphohistiocytoses and Lymphoma, run by Beijing Friendship Hospital at 1 site in China.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Hemophagocytic Lymphohistiocytoses, Lymphoma
- What is being tested?
- cytokine
- How many people
- 89 participants
- Where
- 1 siteChina
- Study dates
- 1 Nov 2022to 31 Dec 2025
- How long will I take part?
- 1 Year
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients with lymhoma and patients with lymphoma-associated HLH
Who may be able to join
- Adult, 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.
Who cannot join
- 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 locations and contacts
1 site in 1 country.
About this study
Official title: The Role of Cytokines in Early Diagnosis, Assessment of Response and Prognosis of Patients With Lymphoma-associated Hemophagocytic Lymphohistiocytosis
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.
Read the 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.
- Conditions
- Hemophagocytic Lymphohistiocytoses, Lymphoma
- Being tested
- cytokine
- Keywords
- Hemophagocytic Lymphohistiocytosis, Lymphoma, Cytokine, Diagnosis
- Medical subject headings
- Lymphohistiocytosis, Hemophagocytic, Lymphoma, Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
cytokineDiagnostic test
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.
| Study group | Role | What they receive |
|---|---|---|
| Lymphoma group | Patients with histopathologically confirmed lymphoma who did not receive systemic chemotherapy before enrollment. Receives: Diagnostic Test: cytokine | |
| Lymphoma-associated HLH group | Patients with histopathologically confirmed lymphoma who meet HLH-04 diagnostic criteria, and did not receive systemic chemotherapy before enrollment. Receives: Diagnostic Test: cytokine |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 1 year
Secondary outcomes (1)
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
Measured: 1 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Nov 2022
- Study start1 Nov 2022
- Primary completion1 Nov 2025
- Study completion31 Dec 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hemophagocytic LymphohistiocytosesStudies of the same condition, open and under way.
- More trials run by Beijing Friendship HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Other
- Time perspective
- Prospective
- Enrolment
- 89 participants (actual)
- Target duration
- 1 Year
Sponsor and investigators
- Lead sponsor
- Beijing Friendship Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Zhao Wang, Beijing Friendship Hospital
- Investigators
- Zhao Wang, MD, Principal investigator, Beijing Friendship Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05600959
- Sponsor's protocol ID
- BFH20221009001/BFHHZML20220006
- Status last verified
- Oct 2026
- First submitted
- 27 Oct 2022
- Last updated
- 9 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Role of Cytokines in Early Diagnosis, Assessment of Response and Prognosis of Patients With Lymphoma-associated Hemophagocytic Lymphohistiocytosis
- ClinicalTrials.gov ID
- NCT05600959
- Acronym / sponsor ID
- BFH20221009001/BFHHZML20220006
- Conditions
- Hemophagocytic Lymphohistiocytoses, Lymphoma
- Keywords
- Hemophagocytic Lymphohistiocytosis, Lymphoma, Cytokine, Diagnosis
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 89 participants (actual)
- Lead sponsor
- Beijing Friendship HospitalUniversity, hospital or other
- Study start
- 1 Nov 2022 (actual)
- Primary completion
- 1 Nov 2025 (actual)
- Study completion
- 31 Dec 2025 (actual)
- First posted
- 1 Nov 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Other
- Time perspective
- Prospective
- Target follow-up
- 1 Year
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Lymphoma group | – | Diagnostic Test: cytokinePatients with histopathologically confirmed lymphoma who did not receive systemic chemotherapy before enrollment. |
| Lymphoma-associated HLH group | – | Diagnostic Test: cytokinePatients with histopathologically confirmed lymphoma who meet HLH-04 diagnostic criteria, and did not receive systemic chemotherapy before enrollment. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with lymhoma and patients with lymphoma-associated HLH
Key inclusion criteria (4 listed)
- Adult, 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.
Key exclusion criteria (8 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| cytokinePeripheral 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. | Diagnostic test | Lymphoma group, Lymphoma-associated HLH group |
Primary outcome
The sensitivity and specificity of cytokines to predict lymphoma-associated HLH
Time frame: 1 year
The sensitivity and specificity of cytokines as a means of early diagnosis of lymphoma-associated hemophagocytic lymphohistiocytosis
1 secondary outcome
Dynamic changes of cytokine levels during treatment
Time frame: 1 years
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Oct 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Zhao Wang, MD principal investigator
Beijing Friendship Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Hemophagocytic Lymphohistiocytoses and Lymphoma, run by Beijing Friendship Hospital at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 9 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The sensitivity and specificity of cytokines to predict lymphoma-associated HLH (time frame: 1 year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Oct 2026.