Study to Evaluate Interferon Gamma (IFNγ) and Other Inflammatory Mediators in Patients With Malignancy-Associated Hemophagocytic Lymphohistiocytosis (M-HLH)
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT03259230|
Recruitment Status : Recruiting
First Posted : August 23, 2017
Last Update Posted : August 23, 2017
|Condition or disease||Intervention/treatment|
|Hemophagocytic Lymphohistiocytosis||Other: Blood Draws Other: Data Collection|
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.
|Study Type :||Observational|
|Estimated Enrollment :||50 participants|
|Official Title:||An Observational, Multicenter Study to Evaluate Interferon Gamma (IFNγ) and Other Inflammatory Mediators in Patients With Malignancy-Associated Hemophagocytic Lymphohistiocytosis (M-HLH)|
|Actual Study Start Date :||October 13, 2016|
|Estimated Primary Completion Date :||October 2018|
|Estimated Study Completion Date :||October 2019|
|Malignancy-Associated Hemophagocytic Lymphohistiocytosis||Other: Blood Draws Other: Data Collection|
|Absence of HLH in patients diagnosed with malignancy||Other: Blood Draws Other: Data Collection|
- Levels of Inflammatory Markers in Participants Diagnosed with Malignancy-Associated Hemophagocytic Lymphohistiocytosis (M-HLH) [ Time Frame: 6 months ]
- Relationship of Levels of Inflammatory Markers in Participants Diagnosed with Malignancy-Associated Hemophagocytic Lymphohistiocytosis (M-HLH) and Disease Activity [ Time Frame: 6 months ]
- Relationship Between Genetic Variants of Genes Causing HLH and M-HLH and Associated Inflammatory Markers [ Time Frame: 6 months ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03259230
|Contact: Naval Daver, MDfirstname.lastname@example.org|
|United States, Texas|
|University of Texas MD Anderson Cancer Center||Recruiting|
|Houston, Texas, United States, 77030|
|Contact: Clinical Research Operations CR_Study_Registration@mdanderson.org|
|Principal Investigator:||Naval Daver, MD||M.D. Anderson Cancer Center|