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Axatilimab in Combination With Extracorporeal Photopheresis (ECP) in Chronic Graft-versus-Host Disease

ConditionsChronic Graft Versus Host DiseasecGVHD
Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age12+
SponsorUniversity of Miami

About this trial

The purpose of this study is to see whether giving participants a combination treatment of Axatilimab and Extracorporeal Photopheresis (ECP) is effective against chronic Graft-versus-Host Disease (cGVHD).

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Recipient of allogeneic hematopoietic cell transplantation (HCT).

Age greater or equal to 12.

Prior systemic lines of therapy may include corticosteroids, calcineurin inhibitor (CNI) or sirolimus, or other systemic immunosuppressive agent such as ruxolitinib, belumosudil, or ibrutinib. GVHD prophylaxis does not count as a prior line of therapy.

i. Manifestations progress despite the use of ≥ 1 mg/kg/day prednisone for at least 1 week

Disqualifiers

Pregnancy or breast-feeding.

Active relapse of underlying malignancy.

History or the presence of interstitial pneumonitis or drug-related pneumonitis.

Active gastrointestinal (GI) bleeding.

Trial design

Design model

Single group

Treatments tested in this trial

  • Axatilimab

    Biological/Vaccine

    Axatilimab will be administered intravenously (IV) at a dose of 0.3 mg/kg, beginning as a pre-phase dose two weeks prior to initiation of Extracorporeal Photopheresis (ECP) therapy. Thereafter, Axatilimab will be administered with a frequency of one treatment session bi-weekly during each treatment cycle.

  • Extracorporeal Photopheresis

    Procedure/Surgery

    Mandatory ECP therapy will be administered at a frequency of two treatment sessions per week during Cycles 1 through 3, two treatment bi-weekly during Cycles 4 through 6, and two treatments during week 1 of Cycle 7. Optional ECP therapy will be administered at a frequency of two treatment sessions during weeks 2 and 4 of Cycles 4 through 6, when mandatory ECP is not administered. Optional ECP therapy will also be administered as two treatment sessions during week 3 of Cycle 7. After Cycle 7, participants may receive ECP therapy only at the Investigator's discretion for a maximum Treatment Period of 12 months.

Treatment groups

49 Participants
are divided into 1 treatment group
Group A: Axatilimab in combination with ECP GroupExperimental treatment 2 interventions

Trial outcomes

Primary outcomes

1

Best Overall Response Rate (ORR)

Best overall response rate (ORR) will be reported as the percentage of participants who achieve partial response (PR) or a complete response (CR) to study therapy, as defined by the 2014 National Institutes of Health (NIH) Consensus Development Project on Criteria for Clinical Trials in chronic graft-versus-host disease (cGVHD) while on study treatment.

Time frame
Up to 24 weeks

Secondary outcomes

1

Proportion of participants experiencing treatment-related adverse events (AEs)

Proportion of participants experiencing treatment-related adverse events (AEs) will be reported. AEs, including serious adverse events (SAEs), will be assessed using the National Cancer Institute's Common Terminology Criteria for Adverse Events (NCI CTCAE) version 5.0. Attribution of AEs and SAEs to study treatment will be reported as possibly, probably and definitely related, as determined by the treating physician.

Time frame
Up to 15 months
2

Proportion of participants experiencing serious adverse events (SAEs)

Proportion of participants experiencing serious adverse events (SAEs) will be reported, regardless of attribution to study treatment, as determined by the treating physician. SAEs will be assessed using the National Cancer Institute's Common Terminology Criteria for Adverse Events (NCI CTCAE) version 5.0.

Time frame
Up to 15 months
3

Change in cumulative dose of corticosteroid usage

Change in cumulate dose corticosteroid usage among study participants will be reported, from baseline to 24 weeks and to 1-year post start of Axatilimab. Corticosteroid dosage, recorded as average dose in mg per day, will be recorded at each interval.

Time frame
Baseline, 24 weeks, 1 year
4

Duration of response (DOR)

Duration of response (DOR) is defined as the elapsed time in months from best response (partial response (PR) or complete response (CR)) to documented progression of chronic graft-versus-host disease (cGVHD), start of new therapy, or death for any reason.

Time frame
Up to 15 months

Other outcomes

Sponsors and contacts

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

University of Miami

Lead sponsor

Incyte Corporation

Collaborator

Source ClinicalTrials.gov
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