| Biomarker | Variant | ESCAT | Evidence | Clinical significance | Drugs | Sources |
|---|---|---|---|---|---|---|
| BIO-FLT3-D835 | TKD point mutation (D835Y/V/H/F; ~7% AML, often co-occurs with ITD) | IB | FLT3-D835 (TKD) in newly-diagnosed AML: midostaurin + 7+3 was studied in FLT3-mutant (ITD or TKD) AML in RATIFY (Stone 2017) — benefit driven primarily by ITD subset, with smaller magnitude in TKD. Quizartinib (type II FLT3i) is INACTIVE against TKD D835 (target alternate conformation). Gilteritinib (type I) and midostaurin retain activity. ELN 2022 prognostic impact of D835 alone is intermediate. | midostaurin + 7+3 + HiDAC consolidation + midostaurin maintenance consider gilteritinib (off-label intensification or post-induction maintenance, trial) |
| |
| BIO-FLT3-D835 | TKD point mutation (D835Y/V; relapsed/refractory) | IA | FLT3-D835 in R/R AML: gilteritinib superior to salvage chemo (ADMIRAL, Perl 2019 — pre-specified subset analysis showed activity across both ITD and D835/TKD; D835 subset response rates similar to ITD overall). Gilteritinib is preferred type-I FLT3i for D835-mutant R/R disease. Quizartinib remains contraindicated (no D835 activity). | gilteritinib monotherapy (2L bridge to allo-SCT) gilteritinib + venetoclax + azacitidine (off-label, trial) |
| |
| BIO-FLT3-D835 | F691L gatekeeper resistance mutation (post-FLT3i) | IIA | FLT3-F691L is a gatekeeper mutation arising under FLT3-TKI selective pressure (gilteritinib, quizartinib). Confers cross-resistance to most current FLT3i. Crenolanib (investigational type-I) and next-gen FLT3i retain partial activity. No approved targeted option — clinical trial enrollment or salvage chemo + allo-SCT. | salvage chemo + allo-SCT (preferred when fit) clinical trial (next-gen FLT3i, crenolanib, FF-10101) venetoclax + azacitidine (off-label salvage) |
| |
| BIO-FLT3-ITD | internal tandem duplication (juxtamembrane domain — ~25% of AML) | IA | FLT3-ITD in newly-diagnosed AML: midostaurin + 7+3 induction + high-dose cytarabine consolidation + maintenance improved OS vs chemo alone in fit adults (RATIFY, Stone NEJM 2017 — 4-yr OS HR 0.78). Quizartinib + 7+3 + maintenance also superior in QuANTUM-First (Erba Lancet 2023 — 4-yr OS HR 0.78). FLT3-ITD remains a poor-risk marker (ELN 2022) when allelic ratio high; allo-SCT in CR1 indicated. | midostaurin + 7+3 induction + HiDAC consolidation + midostaurin maintenance quizartinib + 7+3 induction + HiDAC consolidation + quizartinib maintenance (FLT3-ITD specifically) allo-SCT in CR1 (high-allelic-ratio FLT3-ITD or other adverse-risk features) |
| |
| BIO-FLT3-ITD | internal tandem duplication (relapsed/refractory AML) | IA | FLT3-ITD in relapsed/refractory AML: gilteritinib monotherapy superior to salvage chemo (ADMIRAL, Perl NEJM 2019 — OS 9.3 vs 5.6 mo, HR 0.64). Gilteritinib is preferred 2L for FLT3-mutant R/R AML and is a bridge to allo-SCT. Quizartinib also active R/R (QuANTUM-R) but FDA label is 1L only (R/R label withdrawn). | gilteritinib monotherapy (2L bridge to allo-SCT) gilteritinib + venetoclax + azacitidine (off-label intensification, trial) |
|
| ID | Name | Priority | Category | Where to order | Needed for |
|---|---|---|---|---|---|
| TEST-BM-ASPIRATE | Bone Marrow Aspirate | Critical | histology | — | all tracks |
| TEST-BM-TREPHINE | Bone Marrow Trephine | Critical | histology | — | all tracks |
| TEST-CBC | Complete Blood Count with Differential | Critical | lab | — | all tracks |
| TEST-CMP | Comprehensive Metabolic Panel | Critical | lab | — | all tracks |
| TEST-COAG-PANEL | Coagulation Panel | Critical | lab | — | all tracks |
| TEST-FISH-PANEL | FISH (Fluorescence In Situ Hybridization) | Critical | genomic | CSD Lab ✓ (code TBC) | all tracks |
| TEST-FLOW-CYTOMETRY | Flow Cytometry | Critical | histology | CSD Lab ✓ (code TBC) | all tracks |
| TEST-HBV-SEROLOGY | Hepatitis B Serology Panel (HBsAg, anti-HBc total, anti-HBs) | Critical | lab | — | all tracks |
| TEST-HCV-ANTIBODY | HCV Antibody | Critical | lab | — | all tracks |
| TEST-HIV-SEROLOGY | HIV Antibody/Antigen | Critical | lab | — | all tracks |
| TEST-KARYOTYPE | Karyotype | Critical | genomic | CSD Lab ✓ (code TBC) | all tracks |
| TEST-LDH | Lactate Dehydrogenase | Critical | lab | — | all tracks |
| TEST-LFT | Liver Function Tests (ALT, AST, bilirubin, ALP, GGT, albumin) | Critical | lab | — | all tracks |
| TEST-NGS-MYELOID-PANEL | Myeloid NGS Panel | Critical | genomic | CSD Lab ✓ (code TBC) | all tracks |
| TEST-PERIPHERAL-SMEAR | Peripheral Blood Smear | Critical | lab | CSD Lab ✓ (code TBC) | all tracks |
| TEST-PREGNANCY | Beta-HCG | Critical | lab | — | aggressive |
| TEST-CMV-SEROLOGY | CMV IgG/IgM | Standard | lab | — | aggressive |
| TEST-ECHO | Echocardiography | Standard | imaging | — | aggressive |
| TEST-URIC-ACID | Serum Uric Acid | Standard | lab | — | all tracks |
| TEST-D-DIMER | D-Dimer | Desired | lab | — | aggressive |
| Specialist | skill_id | Version | Last reviewed | Sign-offs | Domain |
|---|---|---|---|---|---|
| Cellular therapy specialist (CAR-T) | cellular_therapy_specialist | v0.1.0 | 2026-04-25 | 0 | cellular_therapy |
| Clinical pharmacist | clinical_pharmacist | v0.1.0 | 2026-04-25 | 0 | clinical_pharmacy |
| Hematologist / oncohematologist | hematologist | v0.1.0 | 2026-04-25 | 0 | hematology_oncology |
| Hematopathologist (lymphoma / leukemia / myeloma) | hematopathologist | v0.1.0 | 2026-04-25 | 0 | hematopathology |
| Infectious disease / hepatology | infectious_disease_hepatology | v0.1.0 | 2026-04-25 | 0 | infectious_diseases |
| Medical oncologist (solid-tumor chemotherapist) | medical_oncologist | v0.1.0 | 2026-04-25 | 0 | solid_oncology |
| Molecular geneticist / molecular oncologist | molecular_geneticist | v0.1.0 | 2026-04-25 | 0 | molecular_oncology |
| Palliative care | palliative_care | v0.1.0 | 2026-04-25 | 0 | palliative_care |
| Pathologist (general) | pathologist | v0.1.0 | 2026-04-25 | 0 | pathology |
| Primary care / family physician | primary_care | v0.1.0 | 2026-04-25 | 0 | primary_care |
| Psycho-oncologist | psychologist | v0.1.0 | 2026-04-25 | 0 | psychosocial |
| Radiation oncologist | radiation_oncologist | v0.1.0 | 2026-04-25 | 0 | radiation_oncology |
| Radiologist | radiologist | v0.1.0 | 2026-04-25 | 0 | diagnostic_imaging |
| Social worker / case manager | social_worker_case_manager | v0.1.0 | 2026-04-25 | 0 | psychosocial |
| Surgical oncologist | surgical_oncologist | v0.1.0 | 2026-04-25 | 0 | surgical_oncology |
| Transplant specialist (BMT) | transplant_specialist | v0.1.0 | 2026-04-25 | 0 | cellular_therapy |
No active trials matched this scenario in ctgov.
| Option | UA registration | NSZU | Cost orientation | Access pathway |
|---|---|---|---|---|
| Aggressive plan 7+3 Induction (cytarabine + daunorubicin/idarubicin) ± midostaurin (REG-AML-7-3) | ✓ registered | ✓ covered | ₴-? — verify pathway | NSZU formulary |
| Standard plan Venetoclax + Azacitidine (AML, unfit) — VIALE-A schedule (REG-VEN-AZA-AML) | ✓ registered | ✓ covered | ₴-? — verify pathway | NSZU formulary |
| Aggressive plan 7+3 + fractionated gemtuzumab ozogamicin (CD33+ AML, 1L; ALFA-0701) (REG-AML-7-3-GO) 1/3 component drug(s) not registered in Ukraine +1 | ✗ not registered | ✗ out-of-pocket | ₴-? — verify pathway | not recorded |
| Aggressive plan CPX-351 (Vyxeos) for tAML / AML-MRC 1L (REG-CPX351-AML) 2/2 component drug(s) not registered in Ukraine +1 | ✗ not registered | ✗ out-of-pocket | ₴-? — verify pathway | not recorded |
Cost information is orientation. Verify with a specific pharmacy / foundation / trial site. Status updated: 2026-05-04.