Challenges of conducting clinical trials to prevent or treat disease relapse after allo-HCT
| Agent specific . |
|---|
| Off-target toxicities including cytopenias/additional immunosuppression |
| Induction of GVHD |
| Impairment of effective graft-vs-malignancy effect |
| Drug-drug interactions |
| Disease specific . |
| No singular target for the majority of diseases |
| No validated reliable MRD assays for majority of diseases to act preemptively |
| Competition with other trials/modalities |
| Population specific . |
| Competing risk of opportunistic infection |
| Competing risk of GVHD |
| Trials conducted will have inherent selection bias given early dropout after allo-HCT |
| Industry specific . |
| Reluctance to conduct early-phase trials in the post–allo-HCT setting |
| Access to agents inhibits enrollment in randomized trials |
| Small market |
| Agent specific . |
|---|
| Off-target toxicities including cytopenias/additional immunosuppression |
| Induction of GVHD |
| Impairment of effective graft-vs-malignancy effect |
| Drug-drug interactions |
| Disease specific . |
| No singular target for the majority of diseases |
| No validated reliable MRD assays for majority of diseases to act preemptively |
| Competition with other trials/modalities |
| Population specific . |
| Competing risk of opportunistic infection |
| Competing risk of GVHD |
| Trials conducted will have inherent selection bias given early dropout after allo-HCT |
| Industry specific . |
| Reluctance to conduct early-phase trials in the post–allo-HCT setting |
| Access to agents inhibits enrollment in randomized trials |
| Small market |