Study of RLS-0071 Treatment for Hospitalized Patients with Steroid-Resistant Acute Graft-versus-Host Disease (aGvHD)

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What is this study about?

This clinical trial focuses on evaluating a new treatment for patients with steroid-refractory acute graft-versus-host disease, a condition that can occur after stem cell transplantation when the donated cells attack the recipient’s body. The study tests a medication called RLS-0071, which is given through intravenous infusion, in combination with standard treatment.

The study aims to determine if RLS-0071 is safe and effective for treating this condition. Patients will receive different doses of RLS-0071 over a period of up to 14 days. Some patients will also receive another medication called ruxolitinib as part of their treatment. The treatment will be given to patients while they are in the hospital.

During the study, doctors will monitor how well patients respond to the treatment by checking their symptoms, particularly those affecting the skin, liver, and digestive system. They will also track changes in the patients’ condition for up to 180 days after starting treatment. The study will measure various aspects of patient recovery, including pain levels, ability to eat, and overall well-being.

1 Initial eligibility verification

Your eligibility will be confirmed based on specific criteria, including being over 12 years old and having completed stem cell transplantation with adequate neutrophil recovery.

Your weight should be between 40 kg and 140 kg, and you must have specific blood test results within required ranges.

You must be hospitalized with acute graft versus host disease (aGvHD) and have a minimum performance status score.

2 Treatment initiation

You will receive RLS-0071 through an infusion in the hospital.

The treatment will be given together with or within 48 hours of starting another medication called ruxolitinib (unless this medication is not suitable for you).

The initial treatment period with RLS-0071 lasts 7 days.

3 Monitoring period

Your response to treatment will be evaluated at specific time points: days 7, 14, 28, 56, and 180.

Regular blood tests will be performed to monitor your condition.

Your symptoms will be assessed, particularly focusing on skin condition, liver function, and digestive system symptoms.

4 Follow-up assessments

Your overall health status will be monitored through various tests and examinations.

The medical team will track any changes in your condition and symptoms.

Blood samples will be collected to measure specific markers related to your condition.

Your quality of life and specific symptoms will be evaluated using standardized questionnaires.

5 Study completion

The study continues until day 180 after treatment initiation.

Long-term monitoring will include survival assessment and evaluation of disease status.

Final assessments will be conducted to evaluate the overall effectiveness of the treatment.

Who Can Join the Study?

Must be at least 12 years old
Must have recovered from stem-cell transplantation with blood neutrophil count (a type of white blood cell) above 500/mL for at least 3 consecutive measurements
Must meet the following blood test requirements:
– Neutrophil count above 1000/mL without growth factor support
– Platelet count above 50,000/mL without transfusions
– Liver function tests (AST and ALT) less than 5 times normal limits
– Blood bilirubin less than 6mg/dL
– Normal blood clotting function
Body weight must be between 40 kg and 140 kg
Must provide written informed consent (and assent for minors)
Must be able to communicate effectively with study staff and follow study requirements
Women who can become pregnant must use effective birth control during treatment and for 6 months after
Men with partners who can become pregnant must use effective birth control during treatment and for 3 months after
Must have received first-time stem cell transplant from a donor for blood cancer treatment
Must have steroid-resistant acute graft versus host disease (condition where transplanted cells attack the body) that hasn’t improved with standard steroid treatment
Must have Grade II-IV acute graft versus host disease affecting skin, liver, or digestive system
Must be hospitalized with a Karnofsky Performance Status (measure of patient’s ability to perform ordinary tasks) of at least 50
Expected hospital stay must be at least 1 week
Must be starting or recently started treatment with a medication called ruxolitinib, unless contraindicated
Must be able to start study medication (RLS-0071) within 48 hours of starting ruxolitinib
Must not plan to change other medications for graft versus host disease during the first 7 days of treatment

Who Cannot Join the Study?

Age below 12 years or over 75 years
Known allergic reactions to medications similar to RLS-0071
Active uncontrolled infections
Severe liver problems (defined as liver enzymes more than 3 times above normal levels)
Severe kidney problems (requiring dialysis)
Pregnancy or breastfeeding
Participation in other clinical trials within the last 30 days
Active cancer other than the condition that required stem cell transplant
Uncontrolled heart conditions
History of severe allergic reactions or anaphylaxis (a serious, life-threatening allergic reaction)
Mental conditions that could affect ability to provide informed consent
Use of medications that could interact with the study drug
Severe breathing problems requiring oxygen support
History of organ transplant other than stem cell transplant
HIV, hepatitis B, or hepatitis C infection

Where you can join this trial?

Verified and Recommended Sites

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Verified Sites

Site Name	City	Country
Universitaetsmedizin Goettingen	Goettingen	Germany
Hospital Universitario De Salamanca	Salamanca	Spain
Hospital Universitario Y Politecnico La Fe	Valencia	Spain

Other Sites

Site Name	City	Country
Virgen del Rocío University Hospital	Sevilla	Spain
Charite Universitaetsmedizin Berlin KöR	Berlin	Germany
Medical Center – University Of Freiburg	Freiburg Im Breisgau	Germany
Ufygyyilgm Hlxsltii Cnqayvn	Cologne	Germany
Uvjjesllchbqskfusrkku Mbvbjgps Are	Munster	Germany
Huqowgam Ugolmvsvajcfs Mbgvaix Df Vfdugfwkyv	Santander	Spain

Trial status

Country	Status	Recruitment Start
Germany	Not recruiting	15.12.2024
Spain	Not recruiting	15.12.2024

Trial locations

Investigated drugs:

Ile-Ala-Leu-Ile-Leu-Glu-Pro-Ile-Cys-Cys-Gln-Glu-Arg-Ala-Ala-(Discrete-Polyethylene Glycol)24

RLS-0071 is an investigational medication being studied for the treatment of acute graft versus host disease (aGvHD), a condition that can occur after bone marrow transplantation. The medication is being tested in patients who have not responded well to steroid treatment. This therapy aims to help manage the complications when the transplanted cells attack the recipient’s body tissues. The study is looking at how safe the medication is and how well it works in treating this serious condition.

Investigated diseases:

Acute graft versus host disease

Acute Graft versus Host Disease (aGvHD) – A condition that occurs after bone marrow or stem cell transplantation when the donated immune cells attack the recipient’s body tissues. The disease typically develops within the first 100 days after transplantation and primarily affects the skin, liver, and gastrointestinal tract. The condition begins when the transplanted cells recognize the recipient’s tissues as foreign and launch an immune response against them. The severity can range from mild to severe, with symptoms developing rapidly over days or weeks. Common manifestations include skin rashes, liver dysfunction, and digestive system problems including diarrhea and abdominal pain.

Trial ID:

2024-510582-42-02

Protocol code:

RLS-0071-203

Trial Phase:

Therapeutic exploratory (Phase II)

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Study of RLS-0071 Treatment for Hospitalized Patients with Steroid-Resistant Acute Graft-versus-Host Disease (aGvHD)

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