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NCT04551131 · ClinicalTrials.gov registry record · Phase 1
Use Of A Response-Adapted Ruxolitinib-Containing Regimen For The Treatment Of Hemophagocytic Lymphohistiocytosis
A Phase 1 study of Hemophagocytic Lymphohistiocytosis, sponsored by St. Jude Children's Research Hospital.
- Active
- Registry status
- Phase 1
- Development phase
- 10
- Enrollment target
- 13
- Study locations
NCT04551131 is a Phase 1 study of Hemophagocytic Lymphohistiocytosis that is active but no longer recruiting, run by St. Jude Children's Research Hospital. The registered enrollment target is 10 participants. The trial reports 13 study locations across 11 states.
The verdict
NCT04551131, a Phase 1 study of Hemophagocytic Lymphohistiocytosis, is active but no longer recruiting, sponsored by St. Jude Children's Research Hospital.
- ACTIVE NOT RECRUITING
- Registry status
- Phase 1
- Development phase
- 10 participants
- Enrollment target
- 13
- Study locations
Study Summary
This study is a multi-site Phase Ib/II, 2-arm non-randomized clinical trial to determine the efficacy and tolerability of a response-adapted regimen combining ruxolitinib, dexamethasone, and etoposide as Frontline therapy for patients with newly diagnosed hemophagocytic lymphohistiocytosis (HLH) or as Salvage therapy for patients with relapsed/refractory HLH. Primary Objective * To determine the efficacy and tolerability of a response-adapted ruxolitinib-containing regimen for patients with newly diagnosed HLH. Secondary Objectives * To describe the efficacy and tolerability of a response-adapted ruxolitinib-containing regimen for patients with relapsed/refractory HLH. * To describe the overall response and outcome for patients with newly diagnosed or relapsed/refractory HLH who are treated with this response-adapted ruxolitinib-containing regimen. Exploratory Objectives * To estimate the pharmacokinetic (PK) parameters of ruxolitinib, assess covariates of ruxolitinib pharmacokinetics, and test whether the drug's effectiveness is correlated with systemic drug exposure. * To query specific immunologic biomarkers and determine whether the levels of these biomarkers correlate with disease response and outcome.
Conditions Studied
Interventions
- DRUG Etoposide
- DRUG Dexamethasone
- DRUG Ruxolitinib
Study Locations (13)
California
- Children's Hospital of Orange County - Orange
- University of California San Francisco - San Francisco
Texas
- University of Texas Southwestern Medical Center - Dallas
- Texas Children's Hospital - Houston
Arizona
- Phoenix Children's Hospital - Phoenix
District of Columbia
- Children's National Medical Center - Washington D.C.
Maryland
- John Hopkins University - Baltimore
Massachusetts
- Dana-Farber Cancer Institute - Boston
New York
- Cohen Children's Medical Center - New Hyde Park
North Carolina
- Levine Children's Hospital - Charlotte
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 10 participants |
| Start Date | 2021-07-13 |
| Est. Completion | 2026-08 |
| Phase | Phase 1 |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT04551131
The ClinicalTrials.gov registry entry for NCT04551131 describes a study currently listed as active not recruiting, categorized as Phase 1. The registered enrollment target is 10 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is St. Jude Children's Research Hospital, which has 410 total studies on file at ClinicalTrials.gov.
The record links to 1 condition, with Hemophagocytic Lymphohistiocytosis appearing as the primary indexed condition, and to 3 interventions - of which Etoposide is the first listed.
NCT04551131 reports 13 study locations spanning 11 distinct geographic areas - top geographies include California, Texas, Arizona.
Frequently Asked Questions
What is clinical trial NCT04551131 about?
NCT04551131 is a clinical study titled "Use Of A Response-Adapted Ruxolitinib-Containing Regimen For The Treatment Of Hemophagocytic Lymphohistiocytosis". This study is a multi-site Phase Ib/II, 2-arm non-randomized clinical trial to determine the efficacy and tolerability of a response-adapted regimen combining ruxolitinib, dexamethasone, and etoposide as Frontline therapy for patients with newly diagnosed hemophagocytic lymphohistiocytosis (HLH) or ...
What is the current status of trial NCT04551131?
This trial is currently active not recruiting. It is a Phase 1 study. The enrollment target is 10 participants. The study started on 2021-07-13. Estimated completion is 2026-08.
What conditions does trial NCT04551131 study?
This clinical trial studies the following conditions: Hemophagocytic Lymphohistiocytosis.
What interventions are being tested in trial NCT04551131?
The interventions under investigation include: Etoposide (DRUG), Dexamethasone (DRUG), Ruxolitinib (DRUG).
Who is sponsoring clinical trial NCT04551131?
This trial is sponsored by St. Jude Children's Research Hospital, which has 410 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT04551131 being conducted?
This trial has 13 study locations across Arizona, California, District of Columbia, Maryland, Massachusetts. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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