Study on Axatilimab and Ruxolitinib for Patients with Newly Diagnosed Chronic Graft-Versus-Host Disease

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What is this study about?

This clinical trial is focused on studying a condition known as chronic graft-versus-host disease (cGVHD). This condition can occur after a bone marrow or stem cell transplant, where the donated cells attack the recipient’s body. The study will explore the effects of a treatment combining two medications: Axatilimab and Ruxolitinib. Axatilimab, also known by its code name INCA034176, is given as a solution for infusion, which means it is administered directly into the bloodstream. Ruxolitinib, also known as Jakavi, is taken in tablet form and works by selectively inhibiting certain enzymes involved in the immune response.

The purpose of this study is to evaluate the safety and effectiveness of the combination of Axatilimab and Ruxolitinib in people who have been newly diagnosed with cGVHD. Participants in the study will receive these medications over a period of up to 24 months. Some participants may receive a placebo, which is a substance with no active medication, to help compare the effects of the treatment. The study will monitor how well the treatment works and any side effects that may occur.

Throughout the study, participants will have regular check-ups to assess their response to the treatment and to ensure their safety. The study aims to provide valuable information on whether the combination of Axatilimab and Ruxolitinib can improve outcomes for individuals with cGVHD. This research could potentially lead to better treatment options for those affected by this challenging condition.

1 joining the study

Upon joining the study, participants will be informed about the trial’s purpose and procedures. Participants must be 12 years or older, with new-onset moderate or severe chronic graft-versus-host disease (cGVHD).

2 initial assessment

An initial assessment will be conducted to evaluate the participant’s health status and confirm eligibility based on the 2014 NIH Consensus Criteria for cGVHD.

3 treatment phase

Participants will receive a combination of axatilimab and ruxolitinib. Axatilimab is administered either intravenously (IV) or subcutaneously (SC), while ruxolitinib is taken orally in the form of Jakavi 5 mg tablets.

The dosage and frequency of administration will be determined by the study protocol and the participant’s specific needs.

4 monitoring and follow-up

Participants will be monitored regularly to assess the treatment’s safety and effectiveness. This includes evaluating the frequency and severity of any adverse effects and changes in clinical and laboratory assessments.

The primary goal is to achieve an overall response at 6 months, defined as complete or partial response without the need for new systemic therapy for cGVHD.

5 response evaluation

At 6 months, the participant’s response to the treatment will be evaluated based on the 2014 NIH Criteria. The study aims to determine the best overall response within the first 6 months and throughout the study.

6 extended observation

Participants will continue to be observed for up to 12 months to assess long-term outcomes, including the duration of response and any improvements in symptoms.

The study will also evaluate pharmacokinetic parameters for axatilimab and ruxolitinib to understand how the drugs are processed in the body.

Who Can Join the Study?

Participants must be 12 years or older at the time of giving consent to join the study. However, those aged 12-17 years will not be included in certain regions.
Participants should have new-onset moderate or severe chronic graft-versus-host disease (cGVHD). This is a condition that can occur after a stem cell transplant, where the donated cells attack the recipient’s body.
Participants must have a history of one allogeneic stem cell transplant (allo-SCT). This means they have received stem cells from a donor.
Participants must be willing to avoid pregnancy or fathering children during the study.

Who Cannot Join the Study?

Patients who have a different condition than chronic graft-versus-host disease cannot participate. This is a condition that can occur after a bone marrow transplant, where the donated cells attack the recipient’s body.
Patients who are not within the specified age range cannot participate. The trial is open to certain age groups, so those outside these groups are excluded.
Patients who are not able to follow the study procedures or who have other health issues that might interfere with the study cannot participate.
Patients who are pregnant or breastfeeding cannot participate, as the effects on the baby are unknown.
Patients who are taking certain medications that might interfere with the study drugs cannot participate.
Patients who have had a recent infection or other serious health condition that might affect the study results cannot participate.
Patients who have participated in another clinical trial recently may not be eligible to participate in this one.

Where you can join this trial?

Verified and Recommended Sites

No sites found in this category

Verified Sites

Site Name	City	Country
Fondazione Policlinico Universitario Agostino Gemelli IRCCS	Rome	Italy
Hospital Universitario Y Politecnico La Fe	Valencia	Spain
Hospital Universitario De Salamanca	Salamanca	Spain
Katholieke Universiteit te Leuven	Leuven	Belgium
IRCCS Humanitas Research Hospital	Rozzano	Italy

Other Sites

Site Name	City	Country
Centre hospitalier universitaire de Liege	Liege	Belgium
Hospital General Universitario Gregorio Maranon	Madrid	Spain
Hospital Universitario 12 De Octubre	Madrid	Spain
Algemeen Ziekenhuis Delta	Roeselare	Belgium
Hospital Universitario Virgen De Las Nieves	Granada	Spain
Virgen del Rocío University Hospital	Sevilla	Spain
Universitaetsklinikum Regensburg AöR	Regensburg	Germany
Fondazione IRCCS Ca Granda Ospedale Maggiore Policlinico	Milan	Italy
Hospital Clinic De Barcelona	Barcelona	Spain
Az St-Jan Brugge-Oostende A.V.	Brugge	Belgium
Universitaetsklinikum Mannheim GmbH	Mannheim	Germany
University Clinical Hospital Virgen De La Arrixaca	Murcia	Spain
Jessa Ziekenhuis	Hasselt	Belgium
Medical Center – University Of Freiburg	Freiburg Im Breisgau	Germany
Ospedale Pediatrico Bambino Gesu’	Rome	Italy
Institut fuer Klinische Transfusionsmedizin Jena gGmbH	Jena	Germany
Uopbnsyfbz Mkahdyr Chnbcy Hiqirmelrdncrxyep	Hamburg	Germany
Hjtoovav Uiskkpgohnkxw Mzhvtcc Dx Vdheptumuz	Santander	Spain
Ijphfxdh Cmgfsv Duxzmdsyyinnzmjwx	L'hospitalet De Llobregat	Spain
Ajkagmv Ohttstnkzcn Uxgaqkbehxjwh Cewvaciogzju Dkjob Sdqegq E Dotyj Skfmryk Df Tbrluw	Turin	Italy
Gfetnq Ujmohvehwm Fitdfwomh	Frankfurt	Germany
Axdxjuh Uungl Stglaqtlb Lwvezd Dm Bulurus	Bologna	Italy
Ubwewnwafy Of Aojpvnd	Edegem	Belgium
Avnicqy Osfxkttpnml Posb Gqivvool Xhaen	Bergamo	Italy

Trial status

Country	Status	Recruitment Start
Belgium	Not recruiting	30.09.2024
Germany	Not recruiting	30.09.2024
Italy	Not recruiting	30.09.2024
Spain	Not recruiting	30.09.2024

Trial locations

Investigated drugs:

Axatilimab is a medication being studied for its potential to help treat chronic graft-versus-host disease (cGVHD). It is being tested to see how well it works when used together with another medication, ruxolitinib. The goal is to understand if axatilimab can improve the treatment outcomes for patients with this condition.

Ruxolitinib is a medication that is already used to treat certain conditions, including cGVHD. In this study, it is being combined with axatilimab to see if the combination can provide better results for patients who have been newly diagnosed with chronic graft-versus-host disease.

Investigated diseases:

Chronic graft versus host disease

Chronic Graft-Versus-Host Disease – This condition occurs when donor cells attack the recipient’s body after a stem cell or bone marrow transplant. It can affect various organs, including the skin, liver, and digestive tract. Symptoms may include skin rashes, dry eyes, and mouth, as well as liver dysfunction. Over time, it can lead to scarring and fibrosis of affected tissues. The disease can vary in severity and may persist for months or even years. It is a complex condition that requires careful management to control symptoms and prevent complications.

Trial ID:

2022-502168-19-00

Protocol code:

INCA34176-254

Trial Phase:

Therapeutic exploratory (Phase II)

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Study on Axatilimab and Ruxolitinib for Patients with Newly Diagnosed Chronic Graft-Versus-Host Disease

What is this study about?

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