Ruxolitinib With De-Intensified HLH-94 for the Treatment of Hemophagocytic Lymphohistiocytosis (HLH)

Part of paid clinical trials in Irvine, California.

Sponsor
Jerry Lee, MD, MSc, MPhil
Study ID
NCT06160791
Phase
PHASE2
Status
Recruiting
Apply to this trial

Conditions

  • Hemophagocytic Lymphohistiocytoses

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Ruxolitinib — DRUG
    Administered Orally (PO)
  • Etoposide — DRUG
    Administered IV
  • Dexamethasone — DRUG
    Administered PO or IV
  • Non-interventional Imaging — PROCEDURE
    Participants undergo abdominal ultrasound and/or magnetic resonance imaging (MRI)
  • Research Biopsy — PROCEDURE
    Bone marrow biopsy and lymph node biopsy will be obtained during screening and as clinically indicated throughout the trial.
  • Biospecimen Collection — PROCEDURE
    Undergo blood sample collection

Study Details

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.

Key Dates

Start date
Oct 1, 2024
Status verified
Apr 2026
Primary completion
Dec 31, 2027
Completion
Nov 30, 2029

Study Design

Enrollment
36 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: Treatment (ruxolitinib, dexamethasone, etoposide)
    During induction therapy, participants receive ruxolitinib orally (PO) twice daily (BID) plus de-intensified HLH-94 induction with dexamethasone PO or intravenously (IV) once daily (QD) or BID for 4 weeks and etoposide IV twice a week (BIW) for 2 weeks and then based on response, once a week (QW) for another 2 weeks in the absence of disease progression or unacceptable toxicity. After induction therapy, participants receive continuation therapy with ruxolitinib PO BID on days 1-28 of each cycle. Treatment repeats every 28 days for a total of up to 6 months after first administration of study drug in the absence of disease progression or unacceptable toxicity.

Primary Outcome Measure

Overall response rate (ORR) [ Time Frame: 4 weeks ]

Central Contacts

Locations (3)

FacilityCityStateZIPSite coordinators
University of California, IrvineIrvineCalifornia92697
Hildy Donner
[email protected]
Vanessa Lopez
[email protected]
Elizabeth Brem, MD (PRINCIPAL_INVESTIGATOR)
University of California Davis Comprehensive Cancer CenterSacramentoCalifornia95817
Kylie Blaisdell
[email protected]
Francisco Socola, MD (PRINCIPAL_INVESTIGATOR)
University of California, San FranciscoSan FranciscoCalifornia94143
UCSF Hematopoietic Malignancies Clinical Trial Recruitment
[email protected]
[email protected]
877-827-3222
Jerry Lee, MD (PRINCIPAL_INVESTIGATOR)
Aaron Logan, MD, PhD (SUB_INVESTIGATOR)

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