Loading
MORPHO asked whether taking the FLT3 blocker gilteritinib for two years after a stem-cell transplant keeps leukaemia from returning; across everyone the benefit fell just short of statistical proof, but in the half of patients whose blood tests still showed traces of leukaemia the drug clearly cut relapses.
MORPHO (BMT CTN 1506) was a double-blind, placebo-controlled phase 3 trial run by Astellas with the Blood and Marrow Transplant Clinical Trials Network. Adults with FLT3-ITD acute myeloid leukaemia in first remission who had undergone allogeneic transplant were randomised to gilteritinib or placebo for 24 months. The primary endpoint was relapse-free survival; measurable residual disease (MRD) for FLT3-ITD was assessed before and after transplant with a highly sensitive assay.
Relapse-free survival favoured gilteritinib but the difference was not statistically significant (hazard ratio 0.679, two-sided p 0.0518). About half of participants had detectable MRD before or after transplant, and in that prespecified subgroup gilteritinib halved the hazard of relapse or death, while patients without detectable MRD gained nothing. The trial is one of the first to support choosing post-transplant therapy by MRD, and the standard-of-care text for acute myeloid leukaemia describes FLT3 inhibitor maintenance after transplant for MRD-positive disease on this evidence.
Numbers are from the trial as recorded here; see the source links in the table below. This is orientation, not medical advice: ask your team how closely the trial population matches you.
356 enrolled.
Median not reached in either arm; 356 randomised
SourceNumbers not yet public.
SourceNumbers not yet public.
Source| Endpoint | Arm | n | Value | HR (95% CI) | p | Source |
|---|---|---|---|---|---|---|
| Relapse-free survivalprimary | Gilteritinib maintenance | - | Median not reached in either arm; 356 randomised | 0.679 (0.459 to 1.005) | 0.0518 | link |
| Placebo | - | - | ||||
| Relapse-free survival, MRD detectable before or after transplant (prespecified subgroup, 50.5% of participants) | Gilteritinib maintenance | - | - | 0.515 (0.316 to 0.838) | 0.0065 | link |
| Placebo | - | - | ||||
| Relapse-free survival, MRD not detectable | Gilteritinib maintenance | - | - | 1.213 (0.616 to 2.387) | 0.575 | link |
| Placebo | - | - |
Shares FLT3-mutated acute myeloid leukaemia, Leukaemia (all types), Acute myeloid leukaemia, Small-molecule kinase inhibitors and the tag soc-trials.
Shares Allogeneic stem cell transplantation, Leukaemia (all types), Small-molecule kinase inhibitors and the tag soc-trials.
Shares Leukaemia (all types), Acute myeloid leukaemia and the tag soc-trials.
Shares Leukaemia (all types), Small-molecule kinase inhibitors and the tag soc-trials.
Shares Leukaemia (all types), Small-molecule kinase inhibitors and the tag soc-trials.
Shares Leukaemia (all types), MRD / molecular residual disease testing and the tag soc-trials.
Shares Leukaemia (all types) and the tag soc-trials.
Shares Allogeneic stem cell transplantation and the tag soc-trials.