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A study testing venetoclax for treating acute graft-versus-host disease in patients who received a stem cell transplant from a donor

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What is this trial about?

A plain-language summary of the goals, design and what participants do

This study is looking at acute graft-versus-host disease of the skin, which is a condition that can occur after a person receives a transplant of blood-forming stem cells from a donor. In this condition, the donated cells recognize the recipient's body as foreign and attack it, particularly affecting the skin. The treatment being tested is Venclyxto, which contains the active ingredient venetoclax. This medication comes as film-coated tablets that are taken by mouth in different strengths: 10 mg, 50 mg, and 100 mg. The purpose of this study is to determine the maximum tolerated dose of venetoclax that can be safely given to patients with this condition.

The study will include patients who are at least 18 years old and have received a stem cell transplant from any type of donor. These patients must have developed acute graft-versus-host disease that requires treatment with immune-suppressing medicines such as prednisone. Participants need to be able to swallow tablets and must have adequate blood cell counts, meaning their bone marrow has started working properly after the transplant. The study will test venetoclax at different dose levels to find the highest dose that patients can tolerate without experiencing unacceptable side effects.

During the study, participants will receive venetoclax tablets for up to 56 days. Doctors will monitor how well the treatment works and watch for any side effects. They will check whether the acute graft-versus-host disease improves or gets worse, and they will look at survival rates and other complications. The study will also examine blood samples and tissue samples to understand how venetoclax affects the cells that cause graft-versus-host disease. Researchers will assess the quality of life of participants and measure their fatigue levels throughout the treatment period.

The research process

The trial runs in 5 steps – from screening to follow-up. Each step says what happens and what the team monitors.

Step 1
Initial treatment phase
Upon joining the study, you will begin receiving treatment for acute graft-versus-host disease. This condition occurs after you have received a stem cell transplant from a donor, where the donated cells react against your body's tissues.
You will receive prednisone, a medication that suppresses the immune system, at a dose of 1 to 2 mg per kilogram of your body weight. This is the standard treatment for your condition.
In addition to prednisone, you will begin taking venetoclax, which is the medication being tested in this study. Venetoclax comes in the form of film-coated tablets that you will take by mouth.
The dose of venetoclax you receive will be determined based on the phase of the study and the dose level being tested. The study aims to find the highest dose that can be given safely.
Step 2
First assessment period
You will continue taking venetoclax tablets daily for 28 days.
During this period, your medical team will monitor you closely for any side effects and to assess how well the treatment is working.
Blood tests will be performed to check your blood cell counts, including neutrophils (a type of white blood cell) and platelets (cells that help blood clot).
Your response to treatment will be evaluated to determine if your graft-versus-host disease is improving.
Step 3
Extended treatment period
You will continue taking venetoclax tablets daily for an additional 28 days, bringing the total treatment duration to 56 days.
Your medical team will continue to monitor your safety and the effectiveness of the treatment throughout this period.
Any side effects will be recorded and assessed according to standard toxicity criteria, which classify the severity of side effects from mild to severe.
Step 4
Safety and response monitoring
Throughout the study, your medical team will assess whether venetoclax is safe when combined with standard treatment for graft-versus-host disease.
The response of your condition to treatment will be evaluated, including whether the graft-versus-host disease goes into remission or whether it progresses despite treatment.
Blood samples and possibly tissue samples from affected areas may be collected to study how venetoclax affects the cells causing graft-versus-host disease.
You may be asked to complete questionnaires about your quality of life and fatigue levels to assess how the treatment affects your daily functioning.
Step 5
Ongoing follow-up
After completing the 56-day treatment period, you will continue to be monitored for your overall health and survival.
Your medical team will track any long-term effects of the treatment and monitor for disease relapse or other complications.
The study will continue to collect information about your health outcomes to evaluate the overall effectiveness and safety of venetoclax for treating graft-versus-host disease.

Who can join the trial?

7 criteria

You must provide written informed consent before any study procedures begin
You can be male or female
You must be 18 years old or older at the time you sign the consent form
You must be able to swallow tablets
You must have received an allo-HSCT, which is a transplant where you received blood-forming stem cells from a donor. The donor can be a matched unrelated person, a sibling, or a half-matched family member. The stem cells can come from bone marrow, peripheral blood, or cord blood. All types of conditioning treatments before transplant are allowed
Your transplanted cells must have started working properly, shown by having an absolute neutrophil count (a type of white blood cell that fights infection) greater than 1000 per cubic millimeter AND a platelet count (cells that help blood clot) greater than 20,000 per cubic millimeter
You must have newly diagnosed acute graft-versus-host disease, which is a condition where the transplanted donor cells attack your body. This must be Grade II to IV in severity and must require treatment with prednisone, a steroid medication, at a dose of 1 to 2 milligrams per kilogram of your body weight. A tissue sample from affected organs is recommended but not required. Your blood cell counts must be confirmed within 48 hours before starting the study treatment

Who cannot join the trial?

3 criteria

The study does not list specific reasons why patients cannot participate
However, general factors that typically prevent participation in clinical trials may include having other serious health conditions, taking certain medications that could interfere with the study drug, being pregnant or breastfeeding, or having allergies to the study medication
Your doctor will review your complete medical history to determine if you are eligible to participate in this study

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Verified sites

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Medical University Of Vienna
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Vienna, Austria

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Investigated drugs

Venetoclax is a medicine used to treat certain types of blood cancers. In this study, it is being tested to see if it can help treat acute graft-versus-host disease, which is a complication that can happen after patients receive a stem cell transplant from a donor. The study will test different amounts of this medicine to find the highest dose that patients can take safely without having too many side effects.

Venetoclax

What is already known about the treatment

Venetoclax – Venetoclax is an oral medication taken by mouth in tablet form that is being studied as a potential treatment for acute graft-versus-host disease affecting the skin, a complication that can occur after bone marrow or stem cell transplantation. This medicine works at the molecular level by blocking a specific protein called BCL-2, which helps cancer cells and certain immune cells survive longer than they should, allowing the body to reduce the overactive immune response that damages the skin. Venetoclax is already approved for treating certain blood cancers like leukemia and lymphoma, and researchers are now investigating whether it can safely and effectively treat transplant-related immune complications. This clinical trial is specifically focused on finding the right dose of Venetoclax that patients can tolerate without serious side effects while potentially controlling the harmful immune reaction.

Investigated diseases

Acute Graft-Versus-Host Disease of the Skin – This condition occurs after a person receives transplanted blood stem cells or bone marrow from a donor. The donated immune cells recognize the recipient's skin tissue as foreign and begin to attack it. This immune reaction typically develops within the first few months following the transplant. The skin becomes one of the primary targets of this immune response. Affected individuals may experience skin rashes, redness, and other skin changes. The condition represents the body's complex immune response where the donated cells work against the recipient's own tissues.