Study to Evaluate Interferon Gamma (IFNγ) and Other Inflammatory Mediators in Patients With Malignancy-Associated Hemophagocytic Lymphohistiocytosis (M-HLH)
| Status: | Recruiting |
|---|---|
| Conditions: | Hematology |
| Therapuetic Areas: | Hematology |
| Healthy: | No |
| Age Range: | Any |
| Updated: | 8/12/2018 |
| Start Date: | October 13, 2016 |
| End Date: | October 2019 |
| Contact: | Naval Daver, MD |
| Email: | ndaver@mdanderson.org |
| Phone: | 713-794-4392 |
An Observational, Multicenter Study to Evaluate Interferon Gamma (IFNγ) and Other Inflammatory Mediators in Patients With Malignancy-Associated Hemophagocytic Lymphohistiocytosis (M-HLH)
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.
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.
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.
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.
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:
We found this trial at
1
site
1515 Holcombe Blvd
Houston, Texas 77030
Houston, Texas 77030
713-792-2121
University of Texas M.D. Anderson Cancer Center The mission of The University of Texas MD...
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