Trials Sponsors Conditions Drugs Pricing

Conditions

Keywords

Hemophagocytic LymphohistiocytosisMalignancy-Associated Hemophagocytic LymphohistiocytosisM-HLHPatients with known diagnosis of malignancy without HLHInterferon GammaIFNγBiomarkersInflammatory MarkersBlood drawsData 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

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 DrawsOther: 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 DrawsOther: Data Collection

Interventions

Blood DrawsOther

Absence of HLH in patients diagnosed with malignancyMalignancy-Associated Hemophagocytic Lymphohistiocytosis

Data CollectionOther

Absence of HLH in patients diagnosed with malignancyMalignancy-Associated Hemophagocytic Lymphohistiocytosis

Eligibility Criteria

Sexall

Healthy VolunteersNo

Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

Sampling MethodNon-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.

Sponsors & Collaborators

Swedish Orphan Biovitrum
Industrylead
M.D. Anderson Cancer Center
Othercollaborator

Study Sites (1)

University of Texas MD Anderson Cancer Center

Houston, Texas, 77030, United States

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 CollectionData Collection

Condition Hierarchy (Ancestors)

Histiocytosis, Non-Langerhans-CellHistiocytosisLymphatic DiseasesHemic and Lymphatic Diseases

Intervention Hierarchy (Ancestors)

Specimen HandlingClinical Laboratory TechniquesDiagnostic Techniques and ProceduresDiagnosisPunctures

Results Point of Contact

Title: Medical Director
Organization: Swedish Orphan Biovitrum

Study Officials

Naval Daver, MD
M.D. Anderson Cancer Center
PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee: No
Restrictive Agreement: Yes

Enrollment

40 participants (actual enrollment reported by the registry).

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

Actual (reported)

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

Brief Summary

Registry Overview

Trial Relationships

Study Timeline

Study Start

First Submitted

First Posted

Primary Completion

Study Completion

Results Posted

Conditions

Keywords

Outcome Measures

Primary Outcomes (39)

Study Arms (2)

Malignancy-Associated Hemophagocytic Lymphohistiocytosis

Absence of HLH in patients diagnosed with malignancy

Interventions

Eligibility Criteria

You may qualify if:

Sponsors & Collaborators

Study Sites (1)

Related Links

Biospecimen

MeSH Terms

Conditions

Interventions

Condition Hierarchy (Ancestors)

Intervention Hierarchy (Ancestors)

Results Point of Contact

Study Officials

Publication Agreements

Enrollment

Study Design

Study Record Dates

You may not qualify if:

Source record

Documents

Locations

Brief Summary

Registry Overview

Trial Relationships

Related Scientific Literature

Study Timeline

Study Start

First Submitted

First Posted

Primary Completion

Study Completion

Results Posted

Conditions

Keywords

Outcome Measures

Primary Outcomes (39)

Study Arms (2)

Malignancy-Associated Hemophagocytic Lymphohistiocytosis

Absence of HLH in patients diagnosed with malignancy

Interventions

Eligibility Criteria

You may qualify if:

Sponsors & Collaborators

Study Sites (1)

Related Links

Biospecimen

MeSH Terms

Conditions

Interventions

Condition Hierarchy (Ancestors)

Intervention Hierarchy (Ancestors)

Results Point of Contact

Study Officials

Publication Agreements

Enrollment

Study Design

Study Record Dates

You may not qualify if:

Source record

Documents

Locations