FDA guidance explores trial design, supporting data for GVHD treatments

Last Updated: Monday, November 20, 2023

The U.S. Food and Drug Administration has released draft guidance on the design and conduct of clinical trials on GVHD and the types of supporting data that could ensure efficient drugs and device development for the prevention and treatment of acute and chronic GVHD.

Regulatory Focus

Targeted Oncology

Acute GVHD responds quickly to itolizumab treatment in phase 1b trial

Pediatric Blood & Cancer

Prophylactic donor lymphocyte infusion after haploidentical hematopoietic cell transplantation and post-transplant cyclophosphamide for treatment of high-risk myeloid neoplasms in children: A retrospective study

Bone Marrow Transplantation

Acute GVHD classification based on the dynamics of GVHD skin involvement from its appearance to the start of systemic treatment

Regulatory Focus

FDA guidance explores trial design, supporting data for GVHD treatments

Transplantation and Cellular Therapy

Healthcare resource utilization and costs of steroid-associated complications in patients with graft-versus-host disease

Journal of Clinical Oncology

Naive T-cell depletion to prevent chronic graft-versus-host disease

Blood

A phase 1 study of donor regulatory T-cell infusion plus low-dose interleukin-2 for steroid-refractory chronic graft-vs-host disease

The ASCO Post

Abatacept for prophylaxis of acute graft-vs-host disease

Translation and Cellular Therapy

A phase I trial of SYK inhibition with fostamatinib in the prevention and treatment of chronic graft-versus-host disease

Blood

Prevention of acute GVHD disease using an orthogonal IL-2/IL-2Rβ system to selectively expand regulatory T-cells in vivo

Graft-vs.-Host Disease Resource Center

FDA guidance explores trial design, supporting data for GVHD treatments

Targeted Oncology

Acute GVHD responds quickly to itolizumab treatment in phase 1b trial

Pediatric Blood & Cancer

Prophylactic donor lymphocyte infusion after haploidentical hematopoietic cell transplantation and post-transplant cyclophosphamide for treatment of high-risk myeloid neoplasms in children: A retrospective study

Bone Marrow Transplantation

Acute GVHD classification based on the dynamics of GVHD skin involvement from its appearance to the start of systemic treatment

Regulatory Focus

FDA guidance explores trial design, supporting data for GVHD treatments

Transplantation and Cellular Therapy

Healthcare resource utilization and costs of steroid-associated complications in patients with graft-versus-host disease

Journal of Clinical Oncology

Naive T-cell depletion to prevent chronic graft-versus-host disease

Blood

A phase 1 study of donor regulatory T-cell infusion plus low-dose interleukin-2 for steroid-refractory chronic graft-vs-host disease

The ASCO Post

Abatacept for prophylaxis of acute graft-vs-host disease

Translation and Cellular Therapy

A phase I trial of SYK inhibition with fostamatinib in the prevention and treatment of chronic graft-versus-host disease

Blood

Prevention of acute GVHD disease using an orthogonal IL-2/IL-2Rβ system to selectively expand regulatory T-cells in vivo

Elevated Bilirubin Following Engraftment: Differentiating SOS/VOD From GVHD

Management of Chronic Oral GVHD in Patient with High-Risk AML and Mixed Chimerism

Patient With History of Acute Steroid-Dependent Skin GVHD Develops Chronic GVHD: Part 2