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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT03259230
Other study ID # NI-0501-07
Secondary ID PA16-0129
Status Completed
Phase
First received
Last updated
Start date October 13, 2016
Est. completion date January 29, 2020

Study information

Verified date March 2020
Source NovImmune SA
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

This observational study is designed to provide a better understanding of the potential use of IFNγ and IFNγ-inducible chemokines as markers of HLH disease activity and prognosis, and of the potential of IFNγ as a therapeutic target in M-HLH.


Description:

This is a non-interventional observational study designed to determine the levels of inflammatory markers in patients diagnosed with M‑HLH and to assess the relationship between the biomarkers and disease activity in these patients during the M-HLH course. Inflammatory markers will also be measured in a group of control patients diagnosed with hematological malignancy but without HLH. Inflammatory markers include IFNγ and IFNγ-induced chemokines CXCL9 and CXCL10.

In addition to the blood samples for the biomarker analysis, relevant information gathered by the treating physician will be collected in a data collection form. Whenever possible, collection of serum samples for biomarker analysis and relevant information should occur at M-HLH diagnosis, at regular time intervals during the treatment course as well as at resolution or reactivation of the disease.

Blood samples will also be sent to the study sponsor (NovImmune S.A.) for cytokine testing. Before participant's samples are sent to the sponsor for testing, participant's name and any personal identifying information will be coded to protect participant's privacy.


Recruitment information / eligibility

Status Completed
Enrollment 32
Est. completion date January 29, 2020
Est. primary completion date January 29, 2020
Accepts healthy volunteers No
Gender All
Age group N/A and older
Eligibility Inclusion Criteria:

1. Patients diagnosed with HLH in the context of a malignancy. The diagnosis of M-HLH will be established by the treating physician.

2. The patient or patient's legal representative (in case the patient is < 18 years old) must have consented to the use of their clinical data for research purposes at the site.

3. For the control group, patients with a diagnosis of hematological malignancy and never diagnosed with HLH or no suspicion of HLH

Exclusion Criteria:

N/A

Study Design


Related Conditions & MeSH terms

  • Hemophagocytic Lymphohistiocytosis
  • Lymphohistiocytosis, Hemophagocytic
  • Neoplasms

Intervention

Other:
Blood Draws

Data Collection


Locations

Country Name City State
United States University of Texas MD Anderson Cancer Center Houston Texas

Sponsors (2)

Lead Sponsor Collaborator
NovImmune SA M.D. Anderson Cancer Center

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary Levels of Inflammatory Markers in Participants Diagnosed with Malignancy-Associated Hemophagocytic Lymphohistiocytosis (M-HLH) 6 months
Primary Relationship of Levels of Inflammatory Markers in Participants Diagnosed with Malignancy-Associated Hemophagocytic Lymphohistiocytosis (M-HLH) and Disease Activity 6 months
Primary Relationship Between Genetic Variants of Genes Causing HLH and M-HLH and Associated Inflammatory Markers 6 months
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