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Compares treatment options for Chronic Graft Versus Host Disease
Official title Axatilimab in Combination With Extracorporeal Photopheresis (ECP) in Chronic Graft-versus-Host Disease
ClinicalTrials.gov ID: NCT06663722
What this study is testing
What is Axatilimab?
Axatilimab is an investigational medicine, given as an once-weekly infusion into a vein, being studied as a potential treatment for chronic graft versus host disease.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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).
- Phase 2: a mid-size study of how well it works
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 12 and older
You may be able to join if
- Recipient of allogeneic hematopoietic cell transplantation (HCT).
- Age greater or equal to 12.
- Chronic GVHD per 2014 National Institutes of Health Consensus Criteria (NCC) (Jagasia et al. 2015) or overlap syndrome requiring new therapy in...
- Prior systemic lines of therapy may include corticosteroids, calcineurin inhibitor (CNI) or sirolimus, or other systemic immunosuppressive agent such...
- Steroid refractory is defined as any of the following criteria:
You likely can't join if
- Pregnancy or breast-feeding.
- Active relapse of underlying malignancy.
- History or the presence of interstitial pneumonitis or drug-related pneumonitis.
- Active gastrointestinal (GI) bleeding.
- Inability to tolerate volume shifts associated with ECP (e.g., inadequate renal, hepatic, pulmonary and cardiac function (ejection fraction (EF) \<...
- History of myositis.
See the full eligibility criteria
- Recipient of allogeneic hematopoietic cell transplantation (HCT).
- Age greater or equal to 12.
- Chronic GVHD per 2014 National Institutes of Health Consensus Criteria (NCC) (Jagasia et al. 2015) or overlap syndrome requiring new therapy in patients with at least 2 prior lines of therapy, steroid refractoriness, or...
- 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...
- Steroid refractory is defined as any of the following criteria:
- i. Manifestations progress despite the use of ≥ 1 mg/kg/day prednisone for at least 1 week
- ii. Manifestations persist without improvement despite treatment with ≥ 0.5 mg/kg/day or 1 mg/kg every other day for at least four weeks.
- iii. Recurrence after a CR, or
- iv. Progression after a PR.
- Steroid dependence is defined as inability to control cGVHD symptoms while tapering prednisone below 0.25 mg/kg/day on at least two occasions separated by at least 8 weeks. There must be evidence of clinically active...
- For patients receiving approved or commonly used agents, all GVHD systemic treatments should be discontinued except for corticosteroids and drugs being continued from GVHD prophylaxis at screening.
- Eastern Cooperative Oncology Group (ECOG) performance status 0-3 as assessed at Screening.
- Platelet count \> 50,000 platelets/μL and absolute neutrophil count \> 1,000 cells/μL as measured at Screening.
- Aspartate aminotransferase (AST), alanine aminotransferase (ALT) ≤ 2.5 x upper limit of normal (ULN), unless attributed to presumed cGVHD as measured at Screening.
- Stable dose of corticosteroids for at least 14 days prior to treatment.
- Sexually mature individuals must use contraception as described in Section 4.12. For individuals less than 18 years of age, sexual maturity will be determined as per treating pediatrician.
- Pregnancy or breast-feeding.
- Active relapse of underlying malignancy.
- History or the presence of interstitial pneumonitis or drug-related pneumonitis.
- Active gastrointestinal (GI) bleeding.
- Inability to tolerate volume shifts associated with ECP (e.g., inadequate renal, hepatic, pulmonary and cardiac function (ejection fraction (EF) \< 40%) per Investigator discretion.
- History of myositis.
- History of splenectomy.
- History of pancreatitis.
- History of other malignancy (within 3 years of Screening) unless treated with curative intent and approved by Principal Investigator (PI).
- Significant, uncontrolled, or active comorbid conditions or are unable to adhere to the study requirements.
- Acquired Immune Deficiency Syndrome (AIDS) or active hepatitis B (Hep B) or active hepatitis C (Hep C) infection.
- Prior colony-stimulating factor-1 (CSF-1R) targeted therapies.
- Prior history of ECP treatment failure or intolerance.
- Intolerance to methoxsalen, heparin, or citrate products.
- Patients with aphakia due to risk of increased retinal damage or photosensitive disease (albinism, systemic lupus erythematosus, porphyria).
- Lack of stable IV access. Acceptable forms include central venous catheter, peripherally inserted central catheter (PICC), or peripheral IV line per institutional guidelines.
- Insurance denial of coverage for the ECP procedure.
The study team makes the final eligibility decision.
Where it's taking place
- San Francisco, California, United States
- Miami, Florida, United States
- Chicago, Illinois, United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 12 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include San Francisco, California, United States; Miami, Florida, United States; Chicago, Illinois, United States. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.