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Axatilimab for Sclerotic Chronic Graft-versus-Host Disease

ConditionChronic Graft Versus Host Disease
Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18+
SponsorFred Hutchinson Cancer Center

About this trial

This phase II trial tests how well axatilimab works in treating patients with thickening or hardening (sclerosis) of the skin related to chronic graft-versus-host disease after a donor stem cell transplant. Chronic graft-versus-host disease (cGVHD) remains a major complication of donor stem cell transplants. Sclerosis, while not associated with a higher risk of death, can lead to serious disabilities. Usual treatments for cGVHD can be associated with significant side effects and unsatisfactory outcomes. A monoclonal antibody, like axatilimab, is a type of protein that can bind to certain targets in the body, such as molecules that cause the body to make an immune response (antigens). Axatilimab blocks a receptor and depletes cells that may be involved in the development of inflammation and fibrosis in cGVHD. Giving axatilimab may improve or prevent worsening of sclerosis related to cGVHD in patients after a donor stem cell transplant.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Adults aged 18 and older

Ability to understand and willingness to sign a written informed consent document

Allogeneic stem cell transplant, with active cGVHD requiring systemic treatment. Active cGVHD is defined as the presence of signs and symptoms of cGVHD diagnosed per the 2014 National Institutes of Health (NIH) Consensus Development Project on Criteria for Clinical trials in cGVHD

Sclerotic skin score 2-3 or PROM < 24 or Joints/Fascia score 2-3 due to cGVHD

Disqualifiers

Hospitalization for evaluation or management of an infection within 28 days prior to screening

History or other evidence of significant organ dysfunction that would make the patient, in the opinion of the investigator, unsuitable for the study

On more than 1 mg/kg/day prednisone or prednisone equivalent

History of non-compliance

Trial design

Design model

Single group

Treatments tested in this trial

  • Axatilimab

    Biological/Vaccine

    Given IV

  • Biospecimen Collection

    Procedure/Surgery

    Undergo blood sample collection

  • Questionnaire Administration

    Other intervention

    Ancillary studies

  • Skin Biopsy

    Procedure/Surgery

    Undergo optional skin biopsy

  • Skin Measurement

    Procedure/Surgery

    Undergo optional skin flexibility assessment

Treatment groups

50 Participants
are divided into 1 treatment group
Group A: Treatment (axatilimab)Experimental treatment 5 interventions

Trial outcomes

Primary outcomes

1

Overall response rate (ORR) in sclerotic manifestations

Will be defined as the proportion of patients with objective response per 2014 National Institutes of Health (NIH) skin and joint criteria.

Time frame
Up to 24 weeks, cycle 7 day 1 (cycle length = 28 days)

Secondary outcomes

1

Failure-free survival

Will be defined as survival free from addition of another systemic chronic graft-versus-host disease treatment, relapse or death. Kaplan Meier curves will be generated.

Time frame
Up to 2 years
2

Modified Lee Symptom Scale summary score

The modified Lee symptom scale will be scored according to the recommendation of the developer. A change in the summary score between baseline and follow up of ≥ 6 points will be considered clinically meaningful.

Time frame
Up to 2 years
3

ORR in sclerotic manifestations

Will be defined as the proportion of patients with objective response per 2014 NIH skin and joint criteria.

Time frame
Up to and at cycle 13 day 1, 48 weeks (cycle length = 28 days)
4

Change in patient 0-10 sclerotic scale

Will be defined as the proportion who change by 2 or more points. A change of 2 points on this scale is considered clinically meaningful.

Time frame
Up to and at cycle 7 day 1 (24 weeks) and cycle 13 day 1 (48 weeks) (cycle length = 28 days)

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Fred Hutchinson Cancer Center

Lead sponsor

Incyte Corporation

Collaborator

Source ClinicalTrials.gov
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