Cancer type
AML
Acute myeloid leukemia.
Must-know
1
Molecular MRD during remission in AML
Jongen-Lavrencic et al. New England Journal of Medicine. 2018.
Detection of molecular MRD during complete remission had independent prognostic value for relapse and survival. Persistent mutations associated with clonal hematopoiesis did not, within a 4-year window.
2
MORPHO: gilteritinib maintenance after transplant in FLT3-ITD AML
Levis et al. Journal of Clinical Oncology. 2024.
Relapse-free survival was not improved in the overall FLT3-ITD population (hazard ratio 1.213, 95% CI 0.616–2.387). Relapse-free survival was higher for participants with detectable FLT3-ITD MRD before or after transplant who received gilteritinib.
Listed when a study is a randomized or prospective interventional ctDNA or MRD trial, is cited in NCCN or ESMO guidance, or is a prospective validation cohort in a high-impact journal. Shorter lists mean fewer studies met that rule. No test is ranked.
Trials
Recruiting · Phase 3
NCT07463651 MRD-guided maintenance after transplant in FLT3-ITD acute myeloid leukemia: gilteritinib versus sorafenib
Phase 3 trial of MRD-guided maintenance after allogeneic transplant. The registry primary outcome is measurable residual disease recurrence-free survival. ClinicalTrials.gov lists the study as recruiting.
Regulatory timeline
AML
7 records
- Level 2AMLpositive2016
Assessment of Minimal Residual Disease in Standard-Risk AML (NPM1)
Ivey A, Hills RK, Simpson MA, Jovanovic JV, et al.. N Engl J Med. PMID 26789727. RT-qPCR of NPM1-mutated transcripts in blood
Persistence of NPM1-mutated transcripts in blood after the second chemotherapy cycle was present in 15% of patients and was associated with a greater 3-year relapse risk than absence of transcripts (82% vs 30%; HR 4.80, 95% CI 2.95-7.80, P<0.001) and lower survival (24% vs 75%; HR for death 4.38, 95% CI 2.57-7.47, P<0.001). MRD was the only independent prognostic factor for death in multivariate analysis (HR 4.84, 95% CI 2.57-9.15, P<0.001). Level 2. Foundational NPM1 MRD paper.
- Level 2AMLpositive2020
Impact of Conditioning Intensity of Allogeneic Transplantation for Acute Myeloid Leukemia With Genomic Evidence of Residual Disease
Hourigan CS, Dillon LW, Gui G, Logan BR, et al.. J Clin Oncol. PMID 31860405. NGS genomic evidence of residual disease in blood before alloHCT (BMT CTN 0901)
Among patients who were NGS-positive for residual disease before transplant, 3-year cumulative incidence of relapse was 19% with myeloablative conditioning (MAC) vs 67% with reduced-intensity conditioning (RIC) (P<.001); 3-year OS 61% vs 43% (P=0.02). In multivariable analysis of NGS-positive patients, RIC was associated with increased relapse (HR 6.38, 95% CI 3.37-12.10, P<.001), decreased RFS (HR 2.94, P<.001), and decreased OS (HR 1.97, 95% CI 1.17-3.30, P=0.01). Level 2 (MRD analysis of a randomized conditioning-intensity trial).
- ConsensusAMLpositive2021
2021 Update on MRD in acute myeloid leukemia: a consensus document from the European LeukemiaNet MRD Working Party
Heuser M, Freeman SD, Ossenkoppele GJ, Buccisano F, Hourigan CS, Ngai LL, et al.. Blood. PMID 34724563. ELN-standardized flow and molecular MRD
Updated 2018 ELN MRD recommendations: technical guidance for flow- and molecular-MRD, MRD thresholds, definition of MRD response, and how results should be reported and combined when several techniques are used. Consensus document (not a trial).
- Level 2AMLpositive2024
Measurable Residual FLT3 Internal Tandem Duplication Before Allogeneic Transplant for Acute Myeloid Leukemia
Dillon LW, Gui G, Ravindra N, Andrew G, et al.. JAMA Oncol. PMID 38696205. NGS FLT3-ITD MRD in first-CR blood before alloHCT (Pre-MEASURE / MEASURE consortium lineage)
Cohort study of DNA sequencing on first-CR blood from adults with FLT3-ITD AML before allogeneic transplant, examining the association between pre-HCT MRD level and post-transplant relapse and death. Level 2. Part of the MEASURE / Pre-MEASURE genomic MRD program led by Hourigan and colleagues.
- Level 2AMLpositive2024
Gilteritinib as Post-Transplant Maintenance for AML With Internal Tandem Duplication Mutation of FLT3 (MORPHO)
Levis MJ, Hamadani M, Logan B, Jones RJ, et al.. J Clin Oncol. PMID 38471061. FLT3-ITD MRD pre- and post-HCT (prespecified subgroup) · n=356
356 participants randomized post-HCT to gilteritinib or placebo. Overall RFS difference was not statistically significant (HR 0.679, 95% CI 0.459-1.005, two-sided P=0.0518). 50.5% had MRD detectable pre- or post-HCT; in this prespecified subgroup, gilteritinib was beneficial (HR 0.515, 95% CI 0.316-0.838, P=0.0065), while those without detectable MRD showed no benefit (HR 1.213, 95% CI 0.616-2.387, P=0.575). Level 2 (RCT with prespecified MRD subgroup; not MRD-guided randomization).
- Level 2AMLpositive2025
Measurable residual disease and posttransplantation gilteritinib maintenance for patients with FLT3-ITD-mutated AML
Levis MJ, Hamadani M, Logan BR, Jones RJ, et al.. Blood. PMID 39775763. FLT3-ITD MRD in the MORPHO trial · n=356
Dedicated MRD analysis of post-transplant gilteritinib maintenance in FLT3-ITD AML, expanding the prespecified MRD interaction reported in the 2024 JCO primary paper. Level 2.
- Level 2AMLpositive2024
Postinduction molecular MRD identifies patients with NPM1 AML who benefit from allogeneic transplant in first remission
Othman J, Potter N, Ivey A, Jovanovic J, et al.. Blood. PMID 38364112. Postinduction molecular NPM1 MRD
Postinduction molecular MRD in NPM1-mutated AML used to identify patients who benefit from allogeneic transplant in first complete remission. Level 2.
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