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Study to Evaluate Interferon Gamma (IFNγ) and Other Inflammatory Mediators in Patients With Malignancy-Associated Hemophagocytic Lymphohistiocytosis (M-HLH)

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ClinicalTrials.gov Identifier: NCT03259230
Recruitment Status : Recruiting
First Posted : August 23, 2017
Last Update Posted : August 23, 2017
Sponsor:
Collaborator:
M.D. Anderson Cancer Center
Information provided by (Responsible Party):
NovImmune SA

Brief 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.

Condition or disease Intervention/treatment
Hemophagocytic Lymphohistiocytosis Other: Blood Draws Other: Data Collection

Detailed 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.


Study Type : Observational
Estimated Enrollment : 50 participants
Observational Model: Case-Control
Time Perspective: Other
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


Group/Cohort Intervention/treatment
Malignancy-Associated Hemophagocytic Lymphohistiocytosis Other: Blood Draws Other: Data Collection
Absence of HLH in patients diagnosed with malignancy Other: Blood Draws Other: Data Collection



Primary Outcome Measures :
  1. Levels of Inflammatory Markers in Participants Diagnosed with Malignancy-Associated Hemophagocytic Lymphohistiocytosis (M-HLH) [ Time Frame: 6 months ]
  2. Relationship of Levels of Inflammatory Markers in Participants Diagnosed with Malignancy-Associated Hemophagocytic Lymphohistiocytosis (M-HLH) and Disease Activity [ Time Frame: 6 months ]
  3. Relationship Between Genetic Variants of Genes Causing HLH and M-HLH and Associated Inflammatory Markers [ Time Frame: 6 months ]

Biospecimen Description:
Approximate volume of 500 µl - 1 ml of serum or plasma required per time point. Minimum of 1 ml of whole blood collected for genetic characterization.


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Ages Eligible for Study:   Child, Adult, Senior
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Male and female (adult and children) patients who are diagnosed with M-HLH and that meet the inclusion criteria. In addition, patients with a diagnosis of hematological malignancy in the absence of HLH will be included as a control group.
Criteria

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:


Information from the National Library of Medicine

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


Contacts
Contact: Naval Daver, MD 713-794-4392 ndaver@mdanderson.org

Locations
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   
Sponsors and Collaborators
NovImmune SA
M.D. Anderson Cancer Center
Investigators
Principal Investigator: Naval Daver, MD M.D. Anderson Cancer Center

Additional Information:
Responsible Party: NovImmune SA
ClinicalTrials.gov Identifier: NCT03259230     History of Changes
Other Study ID Numbers: NI-0501-07
PA16-0129 ( Other Identifier: MD Anderson Cancer Center )
First Posted: August 23, 2017    Key Record Dates
Last Update Posted: August 23, 2017
Last Verified: August 2017

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by NovImmune SA:
Hemophagocytic Lymphohistiocytosis
Malignancy-Associated Hemophagocytic Lymphohistiocytosis
M-HLH
Patients with known diagnosis of malignancy without HLH
Interferon Gamma
IFNγ
Biomarkers
Inflammatory Markers
Blood draws
Data collection

Additional relevant MeSH terms:
Neoplasms
Lymphohistiocytosis, Hemophagocytic
Histiocytosis, Non-Langerhans-Cell
Histiocytosis
Lymphatic Diseases
Interferons
Interferon-gamma
Antineoplastic Agents
Antiviral Agents
Anti-Infective Agents