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NCT06160791 · ClinicalTrials.gov registry record · Phase 2
Ruxolitinib With De-Intensified HLH-94 for the Treatment of Hemophagocytic Lymphohistiocytosis (HLH)
A Phase 2 study of Hemophagocytic Lymphohistiocytoses, sponsored by Jerry Lee, MD, MSc, MPhil.
- Recruiting
- Registry status
- Phase 2
- Development phase
- 36
- Enrollment target
- 2
- Study locations
NCT06160791: Recruiting Phase 2 study of Hemophagocytic Lymphohistiocytoses, sponsored by Jerry Lee, MD, MSc, MPhil.
NCT06160791 is a Phase 2 study of Hemophagocytic Lymphohistiocytoses that is actively recruiting participants, run by Jerry Lee, MD, MSc, MPhil. The registered enrollment target is 36 participants, below the 734-participant average among 3 other Hemophagocytic Lymphohistiocytoses trials with a reported enrollment target (95% lower). The trial reports 2 study locations across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT06160791, a Phase 2 study of Hemophagocytic Lymphohistiocytoses, is actively recruiting participants, sponsored by Jerry Lee, MD, MSc, MPhil.
- RECRUITING
- Registry status
- Phase 2
- Development phase
- 36 participants
- Enrollment target
- 2
- Study locations
Study Summary
This phase II trial tests the effects of ruxolitinib in combination with a de-intensified HLH-94 drug regimen has on patients with newly diagnosed hemophagocytic lymphohistiocytosis (HLH), a disorder caused by dysregulated immune responses (that is, immune responses that are too strong and cause inflammatory damage to normal tissues). The therapy used for HLH decreases the activity of the immune system. Ruxolitinib is a type of drug called a kinase inhibitor. It works by blocking the signals that cause inflammatory cells to multiply. De-intensified HLH-94 is a treatment regimen that includes 4 weeks of dexamethasone with the dose being decreased each week, and up to 4 weeks of etoposide. This combination is commonly used to treat HLH. Dexamethasone is a steroid medication that works by fighting inflammation. Etoposide is in a class of medications known as podophyllotoxin derivatives. It blocks a certain enzyme needed for cell division and deoxyribonucleic acid (DNA) repair and may kill cancer cells and is used to kill the types of white blood cells in HLH that are attacking the body. Giving ruxolitinib in combination with a de-intensified HLH-94 drug regimen may reduce toxic exposure to therapy while maintaining efficacy in patients with HLH.
Primary Outcome
The proportion of responder (complete response (CR), complete response with incomplete hematologic recovery, or partial response (PR)) or non-responder at the end of induction using a physician developed response criteria will be reported. Those with non-malignant HLH (nmHLH) will be assessed for response, defined as complete response (CR) + partial response (PR) at 4 weeks. Participants diagnosed with a malignant trigger are recommended to undergo cancer-directed therapy once acute hypercytokin
Conditions Studied
Interventions
- DRUG Etoposide
- DRUG Dexamethasone
- DRUG Ruxolitinib
- PROCEDURE Non-interventional Imaging
- PROCEDURE Research Biopsy
Study Locations (2)
California
- University of California, Irvine - Irvine
- University of California, San Francisco - San Francisco
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 36 participants |
| Start Date | 2024-10-01 |
| Est. Completion | 2029-11-30 |
| Phase | Phase 2 |
What NCT06160791 shows while recruiting
NCT06160791 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 36 participants, a relatively small participant target, below the 734-participant average among 3 other Hemophagocytic Lymphohistiocytoses trials with a reported enrollment target (95% lower).
The record links to 1 condition, with Hemophagocytic Lymphohistiocytoses appearing as the primary indexed condition, and to 5 interventions - of which Etoposide is the first listed.
NCT06160791 reports a single indexed study location in California.
Frequently Asked Questions
What is clinical trial NCT06160791 about?
NCT06160791 is a clinical study titled "Ruxolitinib With De-Intensified HLH-94 for the Treatment of Hemophagocytic Lymphohistiocytosis (HLH)". This phase II trial tests the effects of ruxolitinib in combination with a de-intensified HLH-94 drug regimen has on patients with newly diagnosed hemophagocytic lymphohistiocytosis (HLH), a disorder caused by dysregulated immune responses (that is, immune responses that are too strong and cause inf...
What is the current status of trial NCT06160791?
This trial is currently recruiting. It is a Phase 2 study. The enrollment target is 36 participants. The study started on 2024-10-01. Estimated completion is 2029-11-30.
What conditions does trial NCT06160791 study?
This clinical trial studies the following conditions: Hemophagocytic Lymphohistiocytoses.
What interventions are being tested in trial NCT06160791?
The interventions under investigation include: Etoposide (DRUG), Dexamethasone (DRUG), Ruxolitinib (DRUG), Non-interventional Imaging (PROCEDURE), Research Biopsy (PROCEDURE).
Who is sponsoring clinical trial NCT06160791?
This trial is sponsored by Jerry Lee, MD, MSc, MPhil, which has 1 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT06160791 being conducted?
This trial has 2 study locations across California. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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