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Compares treatment options for Chronic Graft-versus-host-disease
Official title A Study to Evaluate Axatilimab Versus Best Available Therapy in Pediatric Participants With Chronic Graft-Versus-Host Disease After at Least 2 Prior Lines of Systemic Therapy (AGAVE-256)
ClinicalTrials.gov ID: NCT07124078
What this study is testing
What is INCA034176?
INCA034176 is an investigational medicine, being studied as a potential treatment for chronic graft-versus-host-disease.
Also referred to as Axatilimab.
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 study will be conducted to compare Axatilimab Versus Best Available Therapy in Pediatric Participants With Chronic Graft Versus Host Disease After at Least 2 Prior Lines of Systemic Therapy.
- 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 2 to 17
You may be able to join if
- Aged ≥ 2 to \< 18 years at the time of signing the informed consent.
- Active, moderate to severe cGVHD, requiring systemic immune suppression.
- Participants with refractory or recurrent cGVHD who have received at least 2 lines of systemic therapy, including corticosteroids and ruxolitinib.
- Concomitant use of systemic corticosteroids is allowed. Participants on systemic corticosteroids must be on a stable dose of corticosteroids for at...
- Participants must accept to be treated with one of the following BAT options on C1D1: CNI (cyclosporine or tacrolimus), ECP, MMF, an mTOR inhibitor...
You likely can't join if
- Receipt of more than 1 prior allo-HCT. Prior autologous HCT is allowed.
- Evidence of relapse of hematologic disease or treatment for relapse after the allo-SCT was performed, including DLI for the treatment of molecular...
- Systemic treatment with CNIs or mTOR inhibitors started within 2 weeks prior to C1D1.
- Severe renal impairment, that is, GFR \< 30 mL/min/1.73 m2 as estimated using modified Schwartz formula, or end-stage renal disease on dialysis.
- Impaired liver function, defined as total bilirubin \> 1.5 × ULN and/or ALT and AST \> 3 × ULN in participants with no evidence of liver cGVHD.
- History of acute or chronic pancreatitis.
See the full eligibility criteria
- Aged ≥ 2 to \< 18 years at the time of signing the informed consent.
- Active, moderate to severe cGVHD, requiring systemic immune suppression.
- Participants with refractory or recurrent cGVHD who have received at least 2 lines of systemic therapy, including corticosteroids and ruxolitinib.
- Concomitant use of systemic corticosteroids is allowed. Participants on systemic corticosteroids must be on a stable dose of corticosteroids for at least 2 weeks prior to C1D1. Topical and inhaled corticosteroid agents...
- Participants must accept to be treated with one of the following BAT options on C1D1: CNI (cyclosporine or tacrolimus), ECP, MMF, an mTOR inhibitor (everolimus or sirolimus), rituximab, imatinib, methotrexate, or...
- History of allo-HCT from any donor HLA type (related or unrelated donor with any degree of HLA matching) using any graft source (bone marrow, peripheral blood stem cells, or cord blood). Recipients of myeloablative...
- Receipt of more than 1 prior allo-HCT. Prior autologous HCT is allowed.
- Evidence of relapse of hematologic disease or treatment for relapse after the allo-SCT was performed, including DLI for the treatment of molecular relapse. Note: Participants who have received a scheduled DLI as part of...
- Systemic treatment with CNIs or mTOR inhibitors started within 2 weeks prior to C1D1.
- Severe renal impairment, that is, GFR \< 30 mL/min/1.73 m2 as estimated using modified Schwartz formula, or end-stage renal disease on dialysis.
- Impaired liver function, defined as total bilirubin \> 1.5 × ULN and/or ALT and AST \> 3 × ULN in participants with no evidence of liver cGVHD.
- History of acute or chronic pancreatitis.
- Active, symptomatic myositis.
- Female adolescent participants who are pregnant or breastfeeding. Other protocol-defined Inclusion/Exclusion Criteria may apply.
The study team makes the final eligibility decision.
Where it's taking place
- Duarte, California, United States
- Los Angeles, California, United States
- Palo Alto, California, United States
- Washington D.C., District of Columbia, United States
- Orlando, Florida, United States
- Atlanta, Georgia, United States
- New York, New York, United States
- Charlotte, North Carolina, United States
- Durham, North Carolina, United States
- Pittsburgh, Pennsylvania, United States
- Seattle, Washington, United States
- Brussels, Belgium
- Woluwe-Saint-Lambert, Belgium
- Berlin, Germany
- Frankfurt am Main, Germany
- Freiburg im Breisgau, Germany
- Hamburg, Germany
- Hanover, Germany
- Regensburg, Germany
- Bologna, Italy
+ 19 more site(s).
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, 2 years to 17 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Duarte, California, United States; Los Angeles, California, United States; Palo Alto, California, United States; Washington D.C., District of Columbia, United States; Orlando, Florida, United States; Atlanta, Georgia, United States and 33 more location(s). 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.