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Ruxolitinib-Based Regimen for Hemophagocytic Lymphohistiocytosis
Study Summary
This trial is testing a new treatment for hemophagocytic lymphohistiocytosis (HLH) that combines a drug called ruxolitinib with dexamethasone and etoposide. The goal is to see if this new treatment is more effective and has fewer side effects than the standard treatment.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowTimeline
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Trial Design
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Who is running the clinical trial?
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- I have been treated with a JAK inhibitor or alemtuzumab in the last 3 months.My liver is not severely damaged (ALT not over 1000 U/L).I have an active cancer diagnosis.I do not have severe organ dysfunction.I am willing to use a feeding tube if I can't take medicine by mouth.My cancer is only in my brain or spinal cord.You are expected to live for less than 2 weeks.My kidneys are weak (CrCl <15 mL/min) and I am not on dialysis.I have a genetic form of HLH and meet at least 4 of its diagnostic criteria.I have worsening brain symptoms or new abnormal brain scan results, or my spinal fluid tests show signs of inflammation.I have not had HLH treatment, except possibly steroids or anakinra.I likely have fHLH based on specific test results and meet most of the HLH diagnostic criteria.I have a history of HLH and meet the required diagnostic criteria.My blood tests show low neutrophils or platelets, or I've needed platelet transfusions.My previous cancer treatment did not work as expected.I cannot take medications by mouth or through a nose tube.I am currently taking rifampin or St. John's Wort.You have a pre-existing condition related to your joints or muscles.I am either younger than 6 weeks or older than 22 years.I currently have a fever.I currently have active HLH with at least 3 symptoms of relapsed/refractory HLH.I have or might have a fungal infection.I am eligible for the initial treatment phase.I have received at least one dose of ATG and it's been over a week since my last dose.I have previously undergone treatment specifically for HLH.I do not require advanced support for heart or lung failure.I have a fever.I am between 6 weeks and 22 years old.I weigh more than 3 kilograms.I can take medicine by mouth or am willing to use a tube if I can't.I have been diagnosed with active HLH.I am between 6 weeks and 22 years old.I weigh more than 3 kilograms.I am part of the salvage treatment group.My spleen is enlarged and getting worse.I am being treated with specific drugs for my immune system condition, not including steroids or anakinra.I am eligible for initial or subsequent treatment phases.I have had an enlarged spleen before starting the study drug.I've been treated with steroids and etoposide before starting ruxolitinib.You have at least 5 out of 8 specific signs and symptoms of a condition called HLH.
- Group 1: Frontline Arm
- Group 2: Salvage Arm
- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
What conditions is Ruxolitinib typically prescribed to treat?
"Ruxolitinib is a drug commonly prescribed to address synovitis, but it can also be useful in managing ophthalmia, sympathetic disorders, prostate cancer and branch retinal vein occlusion."
Has there been additional research conducted involving Ruxolitinib?
"Currently, 915 clinical trials involving Ruxolitinib are in progress with 230 of these experiments having entered Phase 3. Seattle, Washington hosts most of the investigations; however, there is also a global reach that spans 34,485 locations."
Is the age range for this research limited to those under 45 years old?
"To be accepted as a participant in this study, one must not exceed 22 years of age and should have been alive for at least 6 weeks. Across the board, 224 trials target pediatric patients while 757 clinical studies focus on adults aged 65 or over."
Who meets the criteria to be included in this research endeavor?
"This clinical trial seeks 62 participants aged between 6 weeks and 22 years with hemophagocytic syndromes. In addition to these requirements, patients must possess low or absent NK-cell activity OR demonstrate decreased CD107a mobilization, be able to take medication orally or have a nasogastric tube placed if unable to do so, weigh at least 3 kgs."
Are there numerous locations in the US that are conducting this research?
"There is a total of 11 sites offering this trial. Notable locations include Children's Wisconsin/Medical College of Wisconsin in Milwaukee, Johns Hopkins in Baltimore and University of California San Francisco in San Francisco with 8 other medical centres located throughout the country."
How many participants are being recruited to this clinical research?
"Affirmative. Clinicaltrials.gov's data reveals that this trial is presently recruiting participants, having first been published on July 13th 2021 and lastly updated the same date in 2022. 62 individuals need to be signed up from 11 separate medical facilities."
What positive impact is this research expected to have?
"The primary outcome of this 8-week study pertains to the Adverse Events (AEs) associated with ruxolitinib treatment. Secondary objectives include assessing patients' Overall Response rate, calculating mean Time to Response and estimating one year Survival after initiating therapy."
Are there any opportunities for individuals to participate in this experiment?
"Affirmative. Based on the information posted at clinicaltrials.gov, this research endeavour is now searching for participants and has been since July 13th 2021. This trial requires 62 individuals from 11 different sites to be enrolled before completion."
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