Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
| NCT ID | Title | Phase | Status | Enrollment | Velocity | Design | Start | Completion | Last Updated | Sites | Countries |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT07011810 | Axatilimab for Sclerotic Chronic Graft-versus-Host Disease | PHASE2 | RECRUITING | 50 | — | — | Aug 6, 2025 | Feb 10, 2030 | Mar 27, 2026 | 3 | United States |
| NCT06663722 | Axatilimab in Combination With Extracorporeal Photopheresis (ECP) in Chronic Graft-versus-Host Disease | PHASE2 | RECRUITING | 49 | — | — | May 5, 2025 | May 5, 2030 | May 15, 2026 | 1 | United States |
Will be defined as the proportion of patients with objective response per 2014 National Institutes of Health (NIH) skin and joint criteria.
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.
| Arm | Type | Description |
|---|---|---|
| Treatment (axatilimab) | EXPERIMENTAL | Patients receive axatilimab IV over 30 minutes on days 1 and 15 of cycles 1-6 and then on day 1 of remaining cycles. Cycles repeat every 28 days for up to 24 cycles in the absence of disease progression or unacceptable toxicity. Patients also undergo blood sample collection throughout the study. Additionally, patients may undergo optional skin biopsies and optional skin flexibility assessments throughout the study. |
| Axatilimab in combination with ECP Group | EXPERIMENTAL | Participants in this group will receive Axatilimab in combination with extracorporeal photopheresis (ECP) therapy for up to seven (7) four-week cycles. Total participation duration is about 15 months. |
| Name | Type | Description |
|---|---|---|
| Axatilimab | BIOLOGICAL | Given IV |
| Biospecimen Collection | PROCEDURE | Undergo blood sample collection |
| Questionnaire Administration | OTHER | Ancillary studies |
| Skin Biopsy | PROCEDURE | Undergo optional skin biopsy |
| Skin Measurement | PROCEDURE | Undergo optional skin flexibility assessment |
| Extracorporeal Photopheresis | PROCEDURE | 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. |
Inclusion 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 ...