BridgeMD
Compares treatment options for Chronic Graft Versus Host Disease
Official title Axatilimab for Sclerotic Chronic Graft-versus-Host Disease
ClinicalTrials.gov ID: NCT07011810
What this study is testing
What is Axatilimab?
Axatilimab is an investigational medicine, given as an infusion into a vein, being studied as a potential treatment for chronic graft versus host disease.
Also referred to as Anti-M-CSFR Monoclonal Antibody SNDX-6352, Axatilimab-csfr.
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
- 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.
- Phase 2: a mid-size study of how well it works
- Time commitment: about 2 years
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- 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...
- Sclerotic skin score 2-3 or PROM \< 24 due to cGVHD
- Initial diagnosis of sclerosis within the past 24 weeks (168 days)
You likely can't join if
- 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
- History or other evidence of uncontrolled psychiatric illness that that would limit compliance with study requirements
- Receipt of an investigational agent within 28 days prior to screening
See the full eligibility criteria
- 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)...
- Sclerotic skin score 2-3 or PROM \< 24 due to cGVHD
- Initial diagnosis of sclerosis within the past 24 weeks (168 days)
- No new non-corticosteroid systemic immunosuppressive agent within 28 days prior to screening, unless there is a plan to stop them no later than 21 days after the first dose of axatilimab. Receipt of systemic...
- If patient has been previously treated with systemic immunosuppression for sclerosis, one of the following two conditions must be true: (a) the systemic immunosuppressive treatment(s) were given for at least 60 days and...
- Karnofsky performance status ≥ 60%
- Absolute neutrophil count ≥ 1.0 x 10\^9/L (evaluated during the 28-day screening period)
- Platelet count ≥ 50 x 10\^9/L (evaluated during the 28-day screening period) (without transfusion within 2 weeks of study entry)
- If no suspected or proven liver cGVHD, alanine aminotransferase (ALT) and aspartate aminotransferase (AST) ≤ 2.5 x upper limit of normal (ULN) (evaluated during the 28-day screening period) unless due to Gilbert's...
- If no suspected or proven liver cGVHD, total bilirubin ≤ 1.5 x ULN (evaluated during the 28-day screening period) unless due to Gilbert's disease
- For patients with suspected or documented liver cGVHD, ALT and AST ≤ 5 x ULN (evaluated during the 28-day screening period) unless due to Gilbert's disease
- For patients with suspected or documented liver cGVHD, total bilirubin ≤ 1.5 x ULN (evaluated during the 28-day screening period) unless due to Gilbert's disease
- Estimated creatinine clearance ≥ 30 mL/min based on the institutional formula
- Male and female participants of reproductive potential must be willing to employ highly effective and acceptable forms of contraception from screening through 90 days after the last dose of study treatment.
- Adolescent and adult male patients capable of fathering a child who are non-sterilized and who are not abstinent and intend to be sexually active with a female partner of childbearing potential must use two methods of...
- Female patients of childbearing potential who are not abstinent and intend to be sexually active with a non-sterilized male partner must use at least one highly effective method of contraception from the time of...
- Female people of childbearing potential must have a negative serum pregnancy test within 72 hours prior to treatment initiation. Females of childbearing potential are defined as sexually mature females without prior...
- 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
- History or other evidence of uncontrolled psychiatric illness that that would limit compliance with study requirements
- Receipt of an investigational agent within 28 days prior to screening
- Any evidence (histologic, cytogenetic, molecular, hematologic, or mixed) of relapse of the underlying cancer or post-transplant lymphoproliferative disease at the time of screening
- Diagnosed with another malignancy (other than malignancy for which transplant was performed) within 3 years of study enrollment, unless previously treated with curative intent (e.g. complete resected basal or squamous...
- Active hepatitis B (defined as hepatitis B virus [HBV] surface antigen positive and HBV core antibody positive, with positive HBV deoxyribonucleic acid [DNA], or HBV positive core antibody alone with positive HBV DNA)...
- Suspected active or latent tuberculosis (as confirmed by a positive QuantiFERON® test or other tuberculosis blood test)
- History of acute or chronic pancreatitis
- History of myositis
- Pregnant or breastfeeding
- Previous exposure to colony stimulating factor 1 receptor (CSF-1R) therapies
The study team makes the final eligibility decision.
Where it's taking place
- Tampa, Florida, United States
- Boston, Massachusetts, United States
- Seattle, Washington, 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 study runs about 2 years per participant, based on its public description. The team confirms the exact schedule and number of visits before you enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Tampa, Florida, United States; Boston, Massachusetts, United States; Seattle, Washington, 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.