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NCT03827343 · ClinicalTrials.gov registry record
Retrospective Study of Immunotherapy Related Toxicities and Factors Impacting Outcomes in Children and Adults With Cancer
A clinical trial of Macrophage Activation Syndrome and Primary Hemophagocytic Lymphohistiocytosis, sponsored by National Cancer Institute (NCI).
- Active
- Registry status
- 500
- Enrollment target
- 1
- Study location
NCT03827343: Active study of Macrophage Activation Syndrome and Primary Hemophagocytic Lymphohistiocytosis, sponsored by National Cancer Institute (NCI).
NCT03827343 is a study of Macrophage Activation Syndrome and Primary Hemophagocytic Lymphohistiocytosis that is active but no longer recruiting, run by National Cancer Institute (NCI). The registered enrollment target is 500 participants. The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03827343, a study of Macrophage Activation Syndrome and Primary Hemophagocytic Lymphohistiocytosis, is active but no longer recruiting, sponsored by National Cancer Institute (NCI).
- ACTIVE NOT RECRUITING
- Registry status
- 500 participants
- Enrollment target
- 1
- Study location
Study Summary
Immunotherapy is changing the landscape of cancer therapy. Particularly unique to immunotherapy is the toxicity profile, which differs from chemotherapy-based strategies and can be associated with inflammatory responses and/or autoimmune type reactions resulting from activation of the immune system. Referred to as immune related adverse events (irAEs), these adverse events may require systemic immunosuppression or have other consequences and present unique management challenges. Specific to CAR T-cell and other adoptive cell therapies is the constellation of symptoms referred to as cytokine release syndrome (CRS), which can range in severity from mild to severe, and can require both cytokine directed blockade and/or systemic immunosuppression to ameliorate the side effects. While side effects may be unique to each individual immunotherapy, and may also be patient specific, cumulative experience will help to inform toxicity profiles and improve management of side effects and overall outcomes. Given the number of immunotherapeutic approaches at the NCI, the primary goal of this protocol is to facilitate retrospective chart review of various immunotherapy trials at the NCI used in the treatment of cancer to comprehensively study toxicity profiles. This study will not involve the use of specimens or participant contact. All data that is needed has already been collected on the individual treatment protocols and is available in CRIS records or protocol specific databases. Data will only be collected from treatment protocols where the PI has given permission for use of the data on the trial the subject was enrolled on. This protocol will be amended to incorporate new research objectives and new protocols as necessary.
Primary Outcome
Summary of immunotherapy related toxicity profiles and risk factors across a set of protocols in the NCI.
Conditions Studied
Study Locations (1)
Maryland
- National Cancer Institute (NCI) - Bethesda
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 500 participants |
| Start Date | 2019-01-23 |
| Est. Completion | 2026-12-31 |
What the registry record for NCT03827343 still lists
NCT03827343 is an observational study that tracks outcomes without assigning an intervention. The registered 500 participants enrollment target is mid-sized for trials with a published cap.
The record links to 2 conditions, with Macrophage Activation Syndrome appearing as the primary indexed condition, and to 0 interventions.
NCT03827343 reports a single indexed study location in Maryland.
Frequently Asked Questions
What is clinical trial NCT03827343 about?
NCT03827343 is a clinical study titled "Retrospective Study of Immunotherapy Related Toxicities and Factors Impacting Outcomes in Children and Adults With Cancer". Immunotherapy is changing the landscape of cancer therapy. Particularly unique to immunotherapy is the toxicity profile, which differs from chemotherapy-based strategies and can be associated with inflammatory responses and/or autoimmune type reactions resulting from activation of the immune system....
What is the current status of trial NCT03827343?
This trial is currently active not recruiting. The enrollment target is 500 participants. The study started on 2019-01-23. Estimated completion is 2026-12-31.
What conditions does trial NCT03827343 study?
This clinical trial studies the following conditions: Macrophage Activation Syndrome, Primary Hemophagocytic Lymphohistiocytosis.
Who is sponsoring clinical trial NCT03827343?
This trial is sponsored by National Cancer Institute (NCI), which has 3,257 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT03827343 being conducted?
This trial has 1 study location across Maryland. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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