Evaluation of IFNγ and Inflammatory Mediators in Patients With Malignancy-Associated Hemophagocytic Lymphohistiocytosis

NCT03259230 | Completed Results

• 2 other identifiers: NI-0501-07PA16-0129
• Study Type: observational
• Target: 40
• Locations: 1 country
• Sites: 1

Brief Summary

This observational study is designed to determine the levels of pro-inflammatory markers in patients diagnosed with M-HLH, and to assess whether the cytokine profiles bear an IFNγ signature.

Conditions

Hemophagocytic Lymphohistiocytosis

Keywords

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

Outcome Measures

Primary Outcomes (39)

• Mean Serum Concentration of Inflammatory Biomarker - C-X-C Chemokine Ligand 10 (CXCL10)

  Serum samples was collected at various times after HLH diagnosis to determine the concentration of CXCL10.

  From Day 1 up to 39.5 months

• Mean Serum Concentration of Inflammatory Biomarker - C-X-C Chemokine Ligand 9 (CXCL9)

  Serum samples was collected at various times after HLH diagnosis to determine the concentration of CXCL9.

  From Day 1 up to 39.5 months

• Mean Serum Concentration of Inflammatory Biomarker - Interferon Gamma (IFNg)

  Serum samples was collected at various times after HLH diagnosis to determine the concentration of IFNg.

  From Day 1 up to 39.5 months

• Mean Serum Concentration of Inflammatory Biomarker - Interleukin 10 (IL-10)

  Serum samples was collected at various times after HLH diagnosis to determine the concentration of IL-10.

  From Day 1 up to 39.5 months

• Mean Serum Concentration of Inflammatory Biomarker - Interleukin 1 Beta (IL-1B)

  Serum samples was collected at various times after HLH diagnosis to determine the concentration of IL-1B.

  From Day 1 up to 39.5 months

• Mean Serum Concentration of Inflammatory Biomarker - Interleukin 6 (IL-6)

  Serum samples was collected at various times after HLH diagnosis to determine the concentration of IL-6.

  From Day 1 up to 39.5 months

• Mean Serum Concentration of Inflammatory Biomarker - Neopterin

  Serum samples was collected at various times after HLH diagnosis to determine the concentration of neopterin.

  From Day 1 up to 39.5 months

• Mean Serum Concentration of Inflammatory Biomarker - Tumor Necrosis Factor Alpha (TNFa)

  Serum samples was collected at various times after HLH diagnosis to determine the concentration of TNFa.

  From Day 1 up to 39.5 months

• Mean Serum Concentration of Inflammatory Biomarker - Total Human Interferon Gamma (hIFNg)

  Serum samples was collected at various times after HLH diagnosis to determine the concentration of hIFNg.

  From Day 1 up to 39.5 months

• Mean Serum Concentration of Inflammatory Biomarker - Soluble CD163 (sCD163)

  Serum samples was collected at various times after HLH diagnosis to determine the concentration of sCD163.

  From Day 1 up to 39.5 months

• Mean Serum Concentration of Inflammatory Biomarker - Soluble IL-2 Receptor Alpha (sIL2Ra)

  Serum samples was collected at various times after HLH diagnosis to determine the concentration of sIL2Ra.

  From Day 1 up to 39.5 months

• Mean Serum Concentration of Hemoglobin

  Blood samples was collected at various times after HLH diagnosis to determine the concentration of hemoglobin.

  From Day 1 up to 39.5 months

• Mean Serum Concentration of Hematocrit

  Blood samples was collected at various times after HLH diagnosis to determine the concentration of hematocrit.

  From Day 1 up to 39.5 months

• Mean Serum Concentration of Erythrocytes

  Blood samples was collected at various times after HLH diagnosis to determine the concentration of erythrocytes.

  From Day 1 up to 39.5 months

• Mean Serum Concentration of Leukocytes

  Blood samples was collected at various times after HLH diagnosis to determine the concentration of leukocytes.

  From Day 1 up to 39.5 months

• Mean Serum Concentration of Neutrophils

  Blood samples was collected at various times after HLH diagnosis to determine the concentration of neutrophils.

  From Day 1 up to 39.5 months

• Mean Serum Concentration of Lymphocytes

  Blood samples was collected at various times after HLH diagnosis to determine the concentration of lymphocytes.

  From Day 1 up to 39.5 months

• Mean Serum Concentration of Monocytes

  Blood samples was collected at various times after HLH diagnosis to determine the concentration of monocytes.

  From Day 1 up to 39.5 months

• Mean Serum Concentration of Eosinophils

  Blood samples was collected at various times after HLH diagnosis to determine the concentration of eosinophils.

  From Day 1 up to 39.5 months

• Mean Serum Concentration of Basophils

  Blood samples was collected at various times after HLH diagnosis to determine the concentration of basophils.

  From Day 1 up to 39.5 months

• Mean Serum Concentration of Platelets

  Blood samples was collected at various times after HLH diagnosis to determine the concentration of platelets.

  From Day 1 up to 39.5 months

• Mean Plasma Concentration of Fibrinogen

  Blood samples was collected at various times after HLH diagnosis to determine the concentration of fibrinogen.

  From Day 1 up to 39.5 months

• Mean Plasma Concentration of D-Dimer

  Blood samples was collected at various times after HLH diagnosis to determine the concentration of D-dimer.

  From Day 1 up to 39.5 months

• Mean Serum Concentration of Ferritin

  Blood samples was collected at various times after HLH diagnosis to determine the concentration of ferritin.

  From Day 1 up to 39.5 months

• Mean Serum Concentration of Fasting Triglycerides

  Blood samples was collected at various times after HLH diagnosis to determine the concentration of fasting triglycerides.

  From Day 1 up to 39.5 months

• Mean Serum Concentration of Creatinine

  Blood samples was collected at various times after HLH diagnosis to determine the concentration of creatinine.

  From Day 1 up to 39.5 months

• Mean Plasma Concentration of Blood Urea Nitrogen

  Blood samples was collected at various times after HLH diagnosis to determine the concentration of blood urea nitrogen.

  From Day 1 up to 39.5 months

• Mean Serum Concentration of Albumin

  Blood samples was collected at various times after HLH diagnosis to determine the concentration of albumin.

  From Day 1 up to 39.5 months

• Mean Serum Concentration of Sodium

  Blood samples was collected at various times after HLH diagnosis to determine the concentration of sodium.

  From Day 1 up to 39.5 months

• Mean Serum Concentration of Beta2-Microglobulin

  Blood samples was collected at various times after HLH diagnosis to determine the concentration of beta2-microglobulin.

  From Day 1 up to 39.5 months

• Mean Serum Concentration of Immunoglobulin G (IgG)

  Blood samples was collected at various times after HLH diagnosis to determine the concentration of IgG.

  From Day 1 up to 39.5 months

• Mean Serum Concentration of C-Reactive Protein

  Blood samples was collected at various times after HLH diagnosis to determine the concentration of c-reactive protein.

  From Day 1 up to 39.5 months

• Mean Serum Concentration of Aspartate Aminotransferase

  Blood samples was collected at various times after HLH diagnosis to determine the concentration of aspartate aminotransferase.

  From Day 1 up to 39.5 months

• Mean Serum Concentration of Alanine Aminotransferase

  Blood samples was collected at various times after HLH diagnosis to determine the concentration of alanine aminotransferase.

  From Day 1 up to 39.5 months

• Mean Serum Concentration of Alkaline Phosphatase

  Blood samples was collected at various times after HLH diagnosis to determine the concentration of alkaline phosphatase.

  From Day 1 up to 39.5 months

• Mean Serum Concentration of Lactate Dehydrogenase

  Blood samples was collected at various times after HLH diagnosis to determine the concentration of lactate dehydrogenase.

  From Day 1 up to 39.5 months

• Mean Serum Concentration of Total Bilirubin

  Blood samples was collected at various times after HLH diagnosis to determine the concentration of total bilirubin.

  From Day 1 up to 39.5 months

• Mean Serum Concentration of Conjugated Bilirubin

  Blood samples was collected at various times after HLH diagnosis to determine the concentration of conjugated bilirubin.

  From Day 1 up to 39.5 months

• Mean Serum Concentration of Natural Killer (NK) Cell Activity

  Blood samples was collected at various times after HLH diagnosis to determine the concentration of NK cell activity. A lytic unit 30 (LU30) was defined as the number of effector cells necessary to cause lysis of 30% of its target cells.

  From Day 1 up to 39.5 months

Study Arms (2)

Malignancy-Associated Hemophagocytic Lymphohistiocytosis

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

Other: Blood Draws; Other: Data Collection

Absence of HLH in patients diagnosed with malignancy

Patients with a diagnosis of hematological malignancy and never diagnosed with HLH or no suspicion of HLH (at any time, including time after sample collection in case of use of retrospective sample).

Other: Blood Draws; Other: Data Collection

Interventions

Blood Draws OTHER

Absence of HLH in patients diagnosed with malignancy; Malignancy-Associated Hemophagocytic Lymphohistiocytosis

Data Collection OTHER

Absence of HLH in patients diagnosed with malignancy; Malignancy-Associated Hemophagocytic Lymphohistiocytosis

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• Patients diagnosed with HLH in the context of a malignancy. The diagnosis of M-HLH will be established by the treating physician.
• 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.
• For the control group, patients with a diagnosis of hematological malignancy and never diagnosed with HLH or no suspicion of HLH

You may not qualify if:

• N/A

Sponsors & Collaborators

• Swedish Orphan Biovitrum: lead
• M.D. Anderson Cancer Center: collaborator

Study Sites (1)

University of Texas MD Anderson Cancer Center

Houston, Texas, 77030, United States

Location

Related Links

• University of Texas MD Anderson Cancer Center Website

Biospecimen

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.

MeSH Terms

Conditions

Lymphohistiocytosis, Hemophagocytic

Interventions

Blood Specimen Collection; Data Collection

Condition Hierarchy (Ancestors)

Histiocytosis, Non-Langerhans-Cell; Histiocytosis; Lymphatic Diseases; Hemic and Lymphatic Diseases

Intervention Hierarchy (Ancestors)

Specimen Handling; Clinical Laboratory Techniques; Diagnostic Techniques and Procedures; Diagnosis; Punctures; Surgical Procedures, Operative; Investigative Techniques; Epidemiologic Methods; Health Care Evaluation Mechanisms; Quality of Health Care; Health Care Quality, Access, and Evaluation; Public Health; Environment and Public Health

Results Point of Contact

• Title: Medical Director
• Organization: Swedish Orphan Biovitrum

clinical@sobi.com

+4686972000

Study Officials

• Naval Daver, MD

  M.D. Anderson Cancer Center

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: Yes

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: OTHER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 21, 2017
• First Posted: August 23, 2017
• Study Start: October 13, 2016
• Primary Completion: January 29, 2020
• Study Completion: January 29, 2020
• Last Updated: September 19, 2024
• Results First Posted: September 19, 2024

Record last verified: 2024-09

Locations

US (1)