Hemophagocytic LymphohistiocytosisNCT03259230
Evaluation of IFNγ and Inflammatory Mediators in Patients With Malignancy-Associated Hemophagocytic Lymphohistiocytosis
An observational study of Hemophagocytic Lymphohistiocytosis, run by Swedish Orphan Biovitrum at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Hemophagocytic Lymphohistiocytosis
- What is being tested?
- Blood Draws and Data Collection
- How many people
- 40 participants
- Where
- 1 siteUnited States
- Study dates
- 13 Oct 2016to 29 Jan 2020
- Phase
- Observational
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
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.
Who may be able to join
- 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
Who cannot join
- N/A
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Texas MD Anderson Cancer Center
Houston, Texas, 77030
About this study
Official title: 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 determine the levels of pro-inflammatory markers in patients diagnosed with M-HLH, and to assess whether the cytokine profiles bear an IFNγ signature.
Read the detailed description
This is a 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.
- Conditions
- Hemophagocytic Lymphohistiocytosis
- Being tested
- Blood Draws, Data Collection
- 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
- Medical subject headings
- Lymphohistiocytosis, Hemophagocytic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Blood DrawsOther
Data CollectionOther
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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). Receives: Other: Blood Draws; Other: Data Collection |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: From Day 1 up to 39.5 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Aug 2017
- Study start13 Oct 2016
- Primary completion29 Jan 2020
- Study completion29 Jan 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Hemophagocytic LymphohistiocytosisStudies of the same condition, open and under way.
- More trials run by Swedish Orphan BiovitrumThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Other
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- Swedish Orphan Biovitrum
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- M.D. Anderson Cancer Center
- Responsible party
- Sponsor
- Investigators
- Naval Daver, MD, Principal investigator, M.D. Anderson Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03259230
- Sponsor's protocol ID
- NI-0501-07
- Other IDs
- PA16-0129
- Status last verified
- Sep 2024
- First submitted
- 21 Aug 2017
- Last updated
- 19 Sep 2024
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Sep 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Observational, Multicenter Study to Evaluate Interferon Gamma (IFNγ) and Other Inflammatory Mediators in Patients With Malignancy-Associated Hemophagocytic Lymphohistiocytosis (M-HLH)
- ClinicalTrials.gov ID
- NCT03259230
- Acronym / sponsor ID
- NI-0501-07
- 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
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- Swedish Orphan BiovitrumIndustry (pharma, biotech, devices)
- Collaborators
- M.D. Anderson Cancer Center
- Study start
- 13 Oct 2016 (actual)
- Primary completion
- 29 Jan 2020 (actual)
- Study completion
- 29 Jan 2020 (actual)
- First posted
- 23 Aug 2017 (actual)
- Results
- Posted 19 Sep 2024
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
This is a 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 design
- Observational model
- Case-control
- Time perspective
- Other
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Malignancy-Associated Hemophagocytic Lymphohistiocytosis | – | Other: Blood Draws, Other: Data CollectionPatients diagnosed with HLH in the context of a malignancy. The diagnosis of M-HLH was established by the treating physician. |
| Absence of HLH in patients diagnosed with malignancy | – | Other: Blood Draws, Other: Data CollectionPatients 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). |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- 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.
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (1 listed)
- N/A
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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 |
Primary outcome
Mean Serum Concentration of Inflammatory Biomarker - C-X-C Chemokine Ligand 10 (CXCL10)
Time frame: From Day 1 up to 39.5 months
Serum samples was collected at various times after HLH diagnosis to determine the concentration of CXCL10.
Mean Serum Concentration of Inflammatory Biomarker - C-X-C Chemokine Ligand 9 (CXCL9)
Time frame: From Day 1 up to 39.5 months
Serum samples was collected at various times after HLH diagnosis to determine the concentration of CXCL9.
Mean Serum Concentration of Inflammatory Biomarker - Interferon Gamma (IFNg)
Time frame: From Day 1 up to 39.5 months
Serum samples was collected at various times after HLH diagnosis to determine the concentration of IFNg.
Mean Serum Concentration of Inflammatory Biomarker - Interleukin 10 (IL-10)
Time frame: From Day 1 up to 39.5 months
Serum samples was collected at various times after HLH diagnosis to determine the concentration of IL-10.
Mean Serum Concentration of Inflammatory Biomarker - Interleukin 1 Beta (IL-1B)
Time frame: From Day 1 up to 39.5 months
Serum samples was collected at various times after HLH diagnosis to determine the concentration of IL-1B.
Mean Serum Concentration of Inflammatory Biomarker - Interleukin 6 (IL-6)
Time frame: From Day 1 up to 39.5 months
Serum samples was collected at various times after HLH diagnosis to determine the concentration of IL-6.
Mean Serum Concentration of Inflammatory Biomarker - Neopterin
Time frame: From Day 1 up to 39.5 months
Serum samples was collected at various times after HLH diagnosis to determine the concentration of neopterin.
Mean Serum Concentration of Inflammatory Biomarker - Tumor Necrosis Factor Alpha (TNFa)
Time frame: From Day 1 up to 39.5 months
Serum samples was collected at various times after HLH diagnosis to determine the concentration of TNFa.
Mean Serum Concentration of Inflammatory Biomarker - Total Human Interferon Gamma (hIFNg)
Time frame: From Day 1 up to 39.5 months
Serum samples was collected at various times after HLH diagnosis to determine the concentration of hIFNg.
Mean Serum Concentration of Inflammatory Biomarker - Soluble CD163 (sCD163)
Time frame: From Day 1 up to 39.5 months
Serum samples was collected at various times after HLH diagnosis to determine the concentration of sCD163.
Mean Serum Concentration of Inflammatory Biomarker - Soluble IL-2 Receptor Alpha (sIL2Ra)
Time frame: From Day 1 up to 39.5 months
Serum samples was collected at various times after HLH diagnosis to determine the concentration of sIL2Ra.
Mean Serum Concentration of Hemoglobin
Time frame: From Day 1 up to 39.5 months
Blood samples was collected at various times after HLH diagnosis to determine the concentration of hemoglobin.
Mean Serum Concentration of Hematocrit
Time frame: From Day 1 up to 39.5 months
Blood samples was collected at various times after HLH diagnosis to determine the concentration of hematocrit.
Mean Serum Concentration of Erythrocytes
Time frame: From Day 1 up to 39.5 months
Blood samples was collected at various times after HLH diagnosis to determine the concentration of erythrocytes.
Mean Serum Concentration of Leukocytes
Time frame: From Day 1 up to 39.5 months
Blood samples was collected at various times after HLH diagnosis to determine the concentration of leukocytes.
Mean Serum Concentration of Neutrophils
Time frame: From Day 1 up to 39.5 months
Blood samples was collected at various times after HLH diagnosis to determine the concentration of neutrophils.
Mean Serum Concentration of Lymphocytes
Time frame: From Day 1 up to 39.5 months
Blood samples was collected at various times after HLH diagnosis to determine the concentration of lymphocytes.
Mean Serum Concentration of Monocytes
Time frame: From Day 1 up to 39.5 months
Blood samples was collected at various times after HLH diagnosis to determine the concentration of monocytes.
Mean Serum Concentration of Eosinophils
Time frame: From Day 1 up to 39.5 months
Blood samples was collected at various times after HLH diagnosis to determine the concentration of eosinophils.
Mean Serum Concentration of Basophils
Time frame: From Day 1 up to 39.5 months
Blood samples was collected at various times after HLH diagnosis to determine the concentration of basophils.
Mean Serum Concentration of Platelets
Time frame: From Day 1 up to 39.5 months
Blood samples was collected at various times after HLH diagnosis to determine the concentration of platelets.
Mean Plasma Concentration of Fibrinogen
Time frame: From Day 1 up to 39.5 months
Blood samples was collected at various times after HLH diagnosis to determine the concentration of fibrinogen.
Mean Plasma Concentration of D-Dimer
Time frame: From Day 1 up to 39.5 months
Blood samples was collected at various times after HLH diagnosis to determine the concentration of D-dimer.
Mean Serum Concentration of Ferritin
Time frame: From Day 1 up to 39.5 months
Blood samples was collected at various times after HLH diagnosis to determine the concentration of ferritin.
Mean Serum Concentration of Fasting Triglycerides
Time frame: From Day 1 up to 39.5 months
Blood samples was collected at various times after HLH diagnosis to determine the concentration of fasting triglycerides.
Mean Serum Concentration of Creatinine
Time frame: From Day 1 up to 39.5 months
Blood samples was collected at various times after HLH diagnosis to determine the concentration of creatinine.
Mean Plasma Concentration of Blood Urea Nitrogen
Time frame: From Day 1 up to 39.5 months
Blood samples was collected at various times after HLH diagnosis to determine the concentration of blood urea nitrogen.
Mean Serum Concentration of Albumin
Time frame: From Day 1 up to 39.5 months
Blood samples was collected at various times after HLH diagnosis to determine the concentration of albumin.
Mean Serum Concentration of Sodium
Time frame: From Day 1 up to 39.5 months
Blood samples was collected at various times after HLH diagnosis to determine the concentration of sodium.
Mean Serum Concentration of Beta2-Microglobulin
Time frame: From Day 1 up to 39.5 months
Blood samples was collected at various times after HLH diagnosis to determine the concentration of beta2-microglobulin.
Mean Serum Concentration of Immunoglobulin G (IgG)
Time frame: From Day 1 up to 39.5 months
Blood samples was collected at various times after HLH diagnosis to determine the concentration of IgG.
Mean Serum Concentration of C-Reactive Protein
Time frame: From Day 1 up to 39.5 months
Blood samples was collected at various times after HLH diagnosis to determine the concentration of c-reactive protein.
Mean Serum Concentration of Aspartate Aminotransferase
Time frame: From Day 1 up to 39.5 months
Blood samples was collected at various times after HLH diagnosis to determine the concentration of aspartate aminotransferase.
Mean Serum Concentration of Alanine Aminotransferase
Time frame: From Day 1 up to 39.5 months
Blood samples was collected at various times after HLH diagnosis to determine the concentration of alanine aminotransferase.
Mean Serum Concentration of Alkaline Phosphatase
Time frame: From Day 1 up to 39.5 months
Blood samples was collected at various times after HLH diagnosis to determine the concentration of alkaline phosphatase.
Mean Serum Concentration of Lactate Dehydrogenase
Time frame: From Day 1 up to 39.5 months
Blood samples was collected at various times after HLH diagnosis to determine the concentration of lactate dehydrogenase.
Mean Serum Concentration of Total Bilirubin
Time frame: From Day 1 up to 39.5 months
Blood samples was collected at various times after HLH diagnosis to determine the concentration of total bilirubin.
Mean Serum Concentration of Conjugated Bilirubin
Time frame: From Day 1 up to 39.5 months
Blood samples was collected at various times after HLH diagnosis to determine the concentration of conjugated bilirubin.
Mean Serum Concentration of Natural Killer (NK) Cell Activity
Time frame: From Day 1 up to 39.5 months
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.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Sep 2024.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- University of Texas MD Anderson Cancer Center WebsiteLink provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Naval Daver, MD principal investigator
M.D. Anderson Cancer Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Hemophagocytic Lymphohistiocytosis, run by Swedish Orphan Biovitrum at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 19 Sep 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 19 Sep 2024). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Mean Serum Concentration of Inflammatory Biomarker - C-X-C Chemokine Ligand 10 (CXCL10) (time frame: From Day 1 up to 39.5 months). The study lists 39 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Sep 2024.