Chronic Graft-versus-host-disease Clinical Trial
Official title:
AGAVE-201, A Phase 2, Open-label, Randomized, Multicenter Study to Evaluate the Efficacy, Safety and Tolerability of Axatilimab at 3 Different Doses in Patients With Recurrent or Refractory Active Chronic Graft Versus Host Disease Who Have Received at Least 2 Lines of Systemic Therapy
This is a Phase 2 study to evaluate the efficacy, safety, and tolerability of axatilimab at 3 different dose levels in participants with recurrent or refractory active chronic graft versus host disease (cGVHD) who have received at least 2 prior lines of systemic therapy.
AGAVE-201 is a Phase 2, open-label, randomized, multicenter study to evaluate the efficacy, safety, and tolerability of axatilimab in participants with recurrent or refractory active cGVHD after failure of at least 2 prior lines of systemic therapy due to progression of disease, intolerability, or toxicity. Participants will be randomized to receive 1 of 3 different axatilimab treatment regimens in 28-day treatment cycles for up to 2 years. ;
| Status | Clinical Trial | Phase | |
|---|---|---|---|
| Active, not recruiting |
NCT04189432 -
Efficacy and Safety of SCM-CGH in Patients With Steroid-Refractory or Dependent Chronic Graft-Versus-Host Disease
|
Phase 2 | |
| Terminated |
NCT03557749 -
Monitoring of Immune and Microbial Reconstitution in (HCT) and Novel Immunotherapies
|
||
| Completed |
NCT05121142 -
Study of Ruxolitinib for Acute and Chronic Graft Versus Host Disease
|
Phase 1 | |
| Recruiting |
NCT04202835 -
ATG Plus PTCy vs ATG for CGVHD Prophylaxis
|
Phase 2 | |
| Terminated |
NCT03640481 -
Efficacy and Safety of KD025 in Subjects With cGVHD After At Least 2 Prior Lines of Systemic Therapy
|
Phase 2 | |
| Completed |
NCT01036958 -
Development and Validation of a Symptom Scale for Children With Chronic Graft-versus-Host Disease
|
||
| Recruiting |
NCT04372524 -
Biomarker Verification in Pediatric Chronic GvHD: ABLE 2.0 / PTCTC GVH 1901 Study
|
||
| Active, not recruiting |
NCT03604692 -
A Phase 1/2 Study to Evaluate SNDX- 6352 in Participants With Active cGVHD
|
Phase 1/Phase 2 | |
| Recruiting |
NCT05355675 -
The Association of Microbiota Composition With cGVHD After Allo-HSCT
|
||
| Terminated |
NCT04200365 -
A Study of Itacitinib for the Treatment of Chronic Graft Versus Host Disease (cGVHD)
|
Phase 2 | |
| Not yet recruiting |
NCT06263478 -
A Study to Evaluate the Efficacy, Safety, and Pharmacokinetics of Axatilimab Monotherapy in Japanese Participants With Recurrent or Refractory Active Chronic Graft-Versus-Host Disease
|
Phase 3 | |
| Terminated |
NCT02123966 -
An Open Label Phase II Trial of Topical Sirolimus for the Treatment of Refractory Oral Chronic Graft-versus-Host-Disease
|
Phase 2 | |
| Recruiting |
NCT05692713 -
Polyomic Biomarker Verification in Adult Chronic Graft-Versus-Host Disease (ABLE3.0/CTTC2201)
|
||
| Terminated |
NCT04446182 -
Itacitinib (INCB039110) and Extracorporeal Photopheresis (ECP) for First-Line Treatment in Chronic GVHD
|
Phase 2 | |
| Active, not recruiting |
NCT05305989 -
Extended Treatment and Follow-up of Subjects Treated With Belumosudil in Study KD025-208 or Study KD025-213
|
Phase 2 | |
| Active, not recruiting |
NCT02340676 -
A Phase II Trial of Low-Dose Interleukin-2 (IL-2) Added to Extra-Corporeal Photopheresis for Steroid-Refractory cGVHD
|
Phase 2 | |
| Completed |
NCT04540133 -
Dexamethasone Solution and Dexamethasone in Mucolox™
|
Phase 2 | |
| Not yet recruiting |
NCT03190733 -
A Optimal Anti-Thymoglobuline (ATG) Dose Decrease cGVHD But Not Increase Leukemia Relapse for Haplo-HSCT
|
Phase 4 | |
| Active, not recruiting |
NCT04716075 -
Acalabrutinib in CLL and MCL Patients Subjected to Allogeneic Hematopoietic Stem Cell Transplantation (alloSCT)
|
Phase 2 | |
| Recruiting |
NCT05236062 -
Impact of Exercise on the Complications of Corticosteroids in Patients With GVHD: the RESTART Trial
|
N/A |