Study of Axatilimab for Patients with Chronic Graft Versus Host Disease After Two Prior Treatments

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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 is a complication that can occur after a stem cell or bone marrow transplant, where the donated cells attack the recipient’s body. The treatment being tested in this study is a medication called Axatilimab, which is given as a solution through an intravenous infusion. The study aims to evaluate the effectiveness, safety, and tolerability of Axatilimab at three different doses in patients who have cGVHD that has not responded to at least two previous treatments.

Participants in the study will receive Axatilimab at one of three doses: 0.3 mg/kg every two weeks, 1 mg/kg every two weeks, or 3 mg/kg every four weeks. The study will observe how well the treatment works and monitor any side effects. The goal is to see if Axatilimab can help reduce the symptoms of cGVHD and improve the quality of life for those affected by this condition.

The study will take place over a period of time, with regular check-ups and assessments to track the participants’ progress. This includes monitoring vital signs, conducting physical examinations, and evaluating the response to the treatment. The information gathered from this study will help determine the potential benefits of Axatilimab for patients with cGVHD who have limited treatment options.

1 joining the study

Upon joining the study, eligibility is confirmed based on specific criteria, including age, medical history, and current health status.

Informed consent is required, ensuring understanding of the study’s requirements and restrictions.

2 randomization and initial assessment

Participants are randomly assigned to one of three dosage groups for the medication axatilimab.

Initial health assessments are conducted to establish baseline health metrics.

3 treatment phase

Participants receive axatilimab through intravenous infusion.

Dosage varies: 0.3 mg/kg every two weeks, 1 mg/kg every two weeks, or 3 mg/kg every four weeks.

The treatment continues for a specified number of cycles, with each cycle lasting a set period.

4 monitoring and follow-up

Regular monitoring of health status, including vital signs and laboratory tests, is conducted to assess the medication’s effects.

Participants may continue using certain other medications, such as corticosteroids, if already prescribed.

5 evaluation of response

The primary goal is to evaluate the overall response rate to axatilimab during the first six cycles.

Secondary evaluations include assessing specific health parameters and any side effects experienced.

6 completion of study participation

Upon completing the treatment cycles, a final assessment is conducted to evaluate the overall health outcomes.

Participants receive information on any further steps or follow-up care required.

Who Can Join the Study?

  • Patient must be 18 years of age or older at the time of signing the informed consent.
  • Patients who have received a type of transplant called allogeneic HSCT and have active chronic graft versus host disease (cGVHD) that needs treatment with medicines that suppress the immune system.
  • Patients with refractory (not responding to treatment) or recurrent (comes back after treatment) active cGVHD, even after trying at least 2 different treatments.
  • Patients may have ongoing symptoms of both acute and chronic GVHD at the same time, known as overlap syndrome.
  • Patients must have a Karnofsky Performance Scale score of 60 or higher if they are 16 years or older, or a Lansky Performance Score of 60 or higher if they are younger than 16. These scores measure how well a person can perform daily activities.
  • Patients must have adequate organ and bone marrow function, which will be checked within 14 days before starting the study.
  • Patients must have a creatinine clearance (a measure of kidney function) of 30 milliliters per minute or higher, calculated using specific formulas for adults and children.
  • Both male and female participants are allowed. If applicable, participants must use contraception according to local guidelines.
  • Patients can use a type of medication called calcineurin inhibitors or mTOR inhibitors (like sirolimus or everolimus), but it is not required.
  • Patients can use systemic corticosteroids (a type of medication) but it is not required. If they are using corticosteroids, the dose must be stable for at least 2 weeks before starting the study.
  • Patients must be able to give signed informed consent, which means they understand and agree to follow the study’s rules. For children, a parent or guardian must provide consent, and if possible, the child should also agree.

Who Cannot Join the Study?

Where you can join this trial?

Verified and Recommended Sites

No sites found in this category

Verified Sites

Other Sites

Site Name City Country Status
Hospital General Universitario Gregorio Maranon Madrid Spain
Hospital Universitario Puerta De Hierro De Majadahonda Majadahonda Spain
Algemeen Ziekenhuis Delta Roeselare Belgium
Geniko Nosokomeio Thessalonikis George Papanikolaou Thessaloniki Greece
Hospital Universitario Virgen De Las Nieves Granada Spain
Virgen del Rocío University Hospital Sevilla Spain
Universitaetsklinikum Regensburg AöR Regensburg Germany
Ospedale San Raffaele S.r.l. Milan Italy
Hospital Clinic De Barcelona Barcelona Spain
Centre Hospitalier Lyon Sud Pierre Benite France
Hopital Beaujon Clichy France
Universita Degli Studi Di Brescia Brescia Italy
Hgswwukm Ulyxhwaugybks Munebui Du Vnfiwlcavm Santander Spain
Udnusanwhamvnhbpijyqa Mstcodoj Ahr Munster Germany
Homtufga Vmqi dwblcubf Barcelona Spain
Uwcmkyomou Gnhryyk Htykbtex Atbcxrp Athens Greece
Hfgqegnj Uawshwvhgqmgdq Sjhjgkywnx &ujaiwh Hvuykqh dg Hzfkilccevf STRASBOURG, Alsace France

Want to learn more about this study or check if you can participate? Contact us.

Trial status

Country Status Recruitment Start
Belgium Belgium
Not recruiting
19.07.2021
France France
Not recruiting
19.07.2021
Germany Germany
Not recruiting
19.07.2021
Greece Greece
Not recruiting
19.07.2021
Italy Italy
Not recruiting
19.07.2021
Spain Spain
Not recruiting
19.07.2021

Trial locations

Investigated drugs:

Axatilimab is a medication being studied for its effectiveness, safety, and tolerability in patients with chronic graft versus host disease (cGVHD) who have not responded to at least two previous treatments. This medication is administered through an intravenous infusion and is being tested at different doses to determine the best approach for managing cGVHD symptoms.

Chronic Graft Versus Host Disease (cGVHD) – This is a condition that can occur after a stem cell or bone marrow transplant, where the donated cells attack the recipient’s body. It typically develops several months after the transplant and can affect various organs, including the skin, liver, and digestive tract. Symptoms may include skin rashes, dry mouth, and joint pain. The disease can vary in severity, with some individuals experiencing mild symptoms and others facing more significant health challenges. Over time, cGVHD can lead to chronic inflammation and tissue damage in the affected areas. The progression of the disease can be unpredictable, with periods of improvement and worsening symptoms.

Trial ID:
2024-512978-99-00
Protocol code:
SNDX-6352-0504
NCT ID:
NCT04710576
Trial Phase:
Therapeutic exploratory (Phase II)

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