Bethesda, MDNCT06339177Now EnrollingIRB Ready

Lymphohistiocytosis, Hemophagocytic Clinical Trial in Bethesda, MD

Access cutting-edge lymphohistiocytosis, hemophagocytic treatment through this clinical trial at a research site in Bethesda. Study-provided care at no cost to qualified participants.

Sponsored by National Institute of Allergy and Infectious Diseases (NIAID)

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This study follows strict safety protocols and ethical guidelines

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All study-related lymphohistiocytosis, hemophagocytic treatment provided free

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Why Participate?

  • No-Cost Study Care

  • Local to Bethesda

    Convenient for MD residents

  • Cutting-Edge Treatment

    Access to innovative therapies

  • Expert Medical Care

    Close monitoring by specialists

  • Possible Compensation*

    For time and travel

*Compensation varies by study. Confirm details with coordinator.

Simple Process

  1. 1Submit this form
  2. 2Phone screening
  3. 3Visit Bethesda site if eligible
  4. 4Begin participation

About This Lymphohistiocytosis, Hemophagocytic Study in Bethesda

Background: Hemophagocytic lymphohistiocytosis (HLH) is a disease caused by disrupted immune function. People with HLH are prone to fevers and illnesses, which can be fatal. Some people develop a genetic form of this disease (pHLH), but researchers do not understand why some other people develop a nongenetic form (sHLH). They also do not have good ways to diagnose and treat sHLH. Objective: To learn about sHLH and why some people get it and others do not. Eligibility: Adults aged 18 years and older with sHLH. Design: Participants will be admitted to the study based on a review of their medical records. Those who join will have at least 3 clinical evaluations over 9 to 12 months. These may occur during an inpatient hospitalization if they require medical care or in the outpatient clinic. Participants will also have a physical exam at each visit. Up to half a cup of blood will be drawn at each visit. Participants may also have their blood drawn by their own doctors, who will send the samples to the researchers. Researchers may also contact these participants by telephone or video calls. The blood will be used for clinical tests as well as research. No new treatments will be administered as part of this study; however, standard medications and treatments may be recommended. Participants may opt to continue their visits once a year for 3 more years. Participants may also opt for an extra clinial evaluation 1 week after starting a new treatment. ...

Sponsor: National Institute of Allergy and Infectious Diseases (NIAID)

Who Can Participate

Inclusion Criteria

Aged 18 years or older.
Established diagnosis of sHLH defined by meeting any published criteria, per Table 1:
Meeting the HLH-2004 criteria.
HScore of \>168. For those without a bone marrow biopsy to evaluate for hemophagocytosis (worth 35 points in the criteria), HScore\>134 will be used.
For those with underlying rheumatologic disease: meeting the 2016 American College of Rheumatology criteria for macrophage activation syndrome.
Agree to storage and sharing of study data and biospecimens for future research use. Table 1: Published Criteria for HLH HLH-2004 Criteria: Molecular diagnosis of HLH OR At least 5 of 8 below criteria:
Fever (\>38.4 Degrees Celcius)
Splenomegaly
Cytopenias affecting \>=2 of 3 lineages: Hgb \<9 g/dL, platelets \<10\^5/microliter, neutrophils \<10\^6/microliter
Hypertriglyceridemia (\>256 mg/dL) and/or fibrinogen \<1.5 g/L
Hemophagocytosis on biopsy
Serum ferritin \>=500 ng/mL
Increased serum sCD25 (\>2400 U/mL)
Low or absent NK cell activity HScore: Known immunosuppression: 0 (no) or 18 (yes) Temperature (degrees, Celsius): 0 (\<38.4), 33 (38.4-39.4), 49 (\>39.4) Organomegaly: 0 (no), 23 (liver/spleen), 38 (both) Number of cytopenias: 0 (1 lines), 24 (2 lines), 34 (3 lines) Ferritin (ng/mL): 0 (\<2000), 35 (2000-6000), 50 (\>6000) Triglycerides (mg/dL): 0 (\<1.5), 44 (1.5-4), 66 (\>4) Fibrinogen (g/L): 0 (\>2.5), 30 (\<2.5) AST (IU/mL): 0 (\<30), 19 (\>30) Hemophagocytosis: 0 (no) or 35 (yes) Cutoff value=169 ACR 2016-MAS Criteria: A febrile patient with known or suspected sJIA is classified as having macrophage activation syndrome if the following criteria are met: Ferritin \>684 ng/mL AND any 2 of the following:
Platelets \<=181,000/microliter
AST \>48 IU/mL
Triglycerides \>156 mg/dL
Fibrinogen \<=3.6 g/L Abbreviations: ACR, American College of Rheumatology; AST, aspartate transaminase; Hgb, hemoglobin; HLH, hemophagocytic lymphohistiocytosis; MAS, macrophage activation syndrome; NK, natural killer, sJIA, systemic juvenile idiopathic arthritis.

Exclusion Criteria

An individual who meets any of the following criteria will be excluded from participation in this study:
Currently pregnant.
Any condition that, in the judgment of the investigator, may put the participant at undue risk or make them unsuitable for participation in the study.

Not sure if you qualify? Submit your interest and a study coordinator will help determine your eligibility.

Frequently Asked Questions

Q:Is this study available in Bethesda?

Yes, this clinical trial (NCT06339177) has an active research site in Bethesda, MD that is currently enrolling participants.

Q:Is it safe to participate?

Clinical trials follow strict safety guidelines and ethical standards. This study has been reviewed and approved, and participants are closely monitored by medical professionals. You can withdraw at any time.

Q:Will I be compensated?

Many clinical trials offer compensation for your time and travel expenses. Specific compensation details will be discussed during the screening process. All study-related medical care is provided at no cost.

Q:Can I leave the trial if I change my mind?

Absolutely. Participation is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty.

Still have questions? Our study coordinators are here to help.

Lymphohistiocytosis, Hemophagocytic Treatment Options in Bethesda, MD

If you're searching for lymphohistiocytosis, hemophagocytic treatment options in Bethesda, MD, this clinical trial (NCT06339177) may be an excellent opportunity. Clinical trials provide access to cutting-edge treatments that aren't yet available to the general public, often at no cost to participants.

Our Bethesda research site is actively enrolling participants for this clinical trial. You'll receive care from experienced lymphohistiocytosis, hemophagocytic specialists who are at the forefront of medical research. All study-related care, including examinations, treatments, and monitoring, is provided at no cost to qualified participants.

Looking for more options? Browse all lymphohistiocytosis, hemophagocytic clinical trials near you to find additional studies recruiting in your area.

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