OpenOnco · Treatment Plan

Treatment plan — Acute Myeloid Leukemia

PLAN-AML-RR-GILT-FLT3TKD-001-V1 · v1 · 2026-06-27

Patient

AML-RR-GILT-FLT3TKD-001 · Algorithm: ALGO-AML-2L

DiagnosisAcute Myeloid Leukemia

MOH / ICD-10C92.0

ICD-O-39861/3; C42.1

Clinical significance of mutations (ESCAT)

Tumor-board context — the engine does not use these tiers to rank tracks

Biomarker	Variant	ESCAT	Evidence	Clinical significance	Drugs	Sources
No clinically actionable variants matched in this profile.

Primary current-line option

Aggressive plan

★ DEFAULT

Indication

IND-AML-2L-GILTERITINIB-FLT3

Regimen

Gilteritinib monotherapy for R/R FLT3-mutated AML

Drugs + NSZU

Gilteritinib (DRUG-GILTERITINIB) 120 mg PO once daily · continuous, 28-day cycles, until progression / unacceptable toxicity · PO ✗ Not registered in UA

Supportive care

SUP-PJP-PROPHYLAXIS, SUP-HSV-PROPHYLAXIS, SUP-HBV-PROPHYLAXIS

Reason

Primary current-line option selected by ALGO-AML-2L at step 4; branch-driving red flag: RF-AML-FLT3-ACTIONABLE.

Other current-line alternatives (1 tracks)

Same treatment line; review when biomarker, access, contraindication, or patient-context assumptions change.

Aggressive plan

Indication

IND-AML-2L-IDH2-ENASIDENIB

Regimen

Enasidenib monotherapy for R/R IDH2-mutated AML

Drugs + NSZU

Enasidenib (DRUG-ENASIDENIB) 100 mg PO once daily · continuous, 28-day cycles, until progression / unacceptable toxicity · PO ✗ Not registered in UA

Supportive care

SUP-PJP-PROPHYLAXIS, SUP-HSV-PROPHYLAXIS, SUP-HBV-PROPHYLAXIS

Reason

Current-line alternative presented for HCP consideration

Why this branch was chosen

Triggers from the patient profile that fired and drove the chosen branch.

Step 4 → branch IND-AML-2L-GILTERITINIB-FLT3

RF-AML-FLT3-ACTIONABLE ★ winner: AML with FLT3-ITD or FLT3-TKD mutation — addition of midostaurin (or gilteritinib in r/r) to induction is required (RATIFY trial) SRC-NCCN-AML-2025SRC-RATIFY-STONE-2017SRC-ELN-AML-2022

Pre-treatment investigations

Investigations before treatment start · critical / standard / desired · merged across tracks

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-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-ECHO	Echocardiography	Standard	imaging	—	all tracks
TEST-URIC-ACID	Serum Uric Acid	Standard	lab	—	all tracks

Red flags — PRO / CONTRA aggressive

PRO-AGGRESSIVE

Triggers that push toward the aggressive track

AML with FLT3-ITD or FLT3-TKD mutation — addition of midostaurin (or gilteritinib in r/r) to induction is required (RATIFY trial)RF-AML-FLT3-ACTIONABLE
IDH2 R140Q or R172K activating mutation in AML — ~8-12% prevalence. Enasidenib (IDHIFA / IDHENTIFY — phase-3 R/R AML; monotherapy ORR 38%, CR 19%) is FDA-approved for R/R-AML-IDH2; also active 1L combination with azacitidine in unfit (AG221-AML-005 — ORR 71%). RF-AML-IDH2-MUT-ACTIONABLE

CONTRA-AGGRESSIVE

Hard contraindications to escalation

What NOT to do

Explicit prohibitive rules, each grounded in a regimen / supportive care / contraindication entity

Aggressive plan (IND-AML-2L-GILTERITINIB-FLT3)

Do NOT prescribe without re-testing FLT3 at the time of relapse — FLT3 clone can disappear or evolve; ~25% relapse-loss FLT3.
Do NOT skip baseline + serial ECG + electrolyte correction (K+ ≥4.0, Mg++ ≥2.0) — torsades documented.
Do NOT ignore differentiation syndrome (fever, dyspnea, weight gain, pleural effusion) — fatal without dexamethasone.
Do NOT consider as curative monotherapy — bridging to alloHCT is mandatory for fit responders.
Do NOT combine with strong CYP3A4-inhibitors without dose reduction + intensive QTc monitoring.
Do NOT discontinue on transient cytopenia — recovery is often slow; G-CSF + transfusion support as needed.
Do NOT confirm the plan without funding pathway — drug not registered in Ukraine.

Aggressive plan (IND-AML-2L-IDH2-ENASIDENIB)

Do NOT prescribe without confirmation of IDH2 R140Q or R172K mutation (NGS panel) — enasidenib is not active in IDH2-WT.
Do NOT skip differentiation syndrome education + corticosteroid kit — fatal without immediate dexamethasone.
Do NOT declare non-response earlier than 6 cycles — median time to first response ~1.9 months; slow kinetics.
Do NOT automatically reduce dose for hyperbilirubinemia — if asymptomatic (UGT1A1 inhibition), continue without change.
Do NOT consider as curative monotherapy — bridging to alloHSCT is mandatory for fit responders.
Do NOT combine with strong CYP3A4 inducers without monitoring — reduced exposure.
Do NOT confirm the plan without funding pathway — drug not registered in Ukraine; EU CHMP negative.

Timeline

Treatment timeline — derived from regimen + monitoring schedule

Aggressive plan

Induction · Gilteritinib monotherapy for R/R FLT3-mutated AML

28-day cycles × Continuous until progression / unacceptable toxicity / proceed to alloHCT in CR

Aggressive plan

Induction · Enasidenib monotherapy for R/R IDH2-mutated AML

28-day cycles × Continuous until progression / unacceptable toxicity; proceed to alloHCT in fit responders. Continue ≥6 cycles before declaring non-response (median time to first response ~1.9 mo).

MDT brief

Discussion questions (1, 0 blocking)

OQ-LDH-CURRENT
What is the current LDH? Marker of tumor burden and transformation.
LDH is part of the prognostic indices of indolent lymphomas.
→ hematologist

MDT talk tree (2 steps)

#	Owner	Topic	Action
1	hematologist	Staging / disease burden	What is the current LDH? Marker of tumor burden and transformation.
2	clinical_pharmacist	Specialist review	Chemoimmunotherapy regimen — drug-drug interactions, dose adjustments, premedication.

Skills (recommended) — for consideration (1)

Clinical pharmacist recommended
Chemoimmunotherapy regimen — drug-drug interactions, dose adjustments, premedication.

Data quality

Usable with caveats. No critical default-track gap was found, but the MDT should review the listed caveats before final sign-off.

Biomarker coverage: 0/0 known (100%), 0 missing, 0 default-track gaps
Unevaluated RedFlags: RF-AML-CD33-POS-GO-CANDIDATE, RF-AML-CORE-BINDING-FACTOR-FAVORABLE, RF-AML-EMERGENCY-TLS-LEUKOSTASIS, RF-AML-FRAILTY-AGE, RF-AML-HIGH-RISK-BIOLOGY, RF-AML-IDH1-MUT-ACTIONABLE, RF-AML-IDH2-MUT-ACTIONABLE, RF-AML-INFECTION-SCREENING, RF-AML-KMT2A-ACTIONABLE, RF-AML-MEASURABLE-RESIDUAL-DISEASE, RF-AML-NPM1-MUT-FAVORABLE, RF-AML-ORGAN-DYSFUNCTION, RF-AML-SECONDARY-AML-MRC-CPX351-ELIGIBLE, RF-AML-TP53-ADVERSE, RF-AML-TRANSFORMATION-PROGRESSION, RF-IATROGENIC-ALKYLATOR-TAML-PREVENTION, RF-IATROGENIC-ANTHRACYCLINE-CARDIO-PREVENTION, RF-IATROGENIC-ANTHRACYCLINE-LATE-CARDIO-PREVENTION, RF-IATROGENIC-PLATINUM-LATE-PREVENTION, RF-IATROGENIC-PRIOR-RADIATION-PREVENTION, RF-IATROGENIC-TOPO2-TAML-PREVENTION, RF-LI-FRAUMENI-CONFIRMED-CARRIER, RF-LI-FRAUMENI-FAMILY-HISTORY-SUSPICION, RF-LIFESTYLE-TOBACCO-CANCER-PREVENTION, RF-MPN-SECONDARY-LEUKEMIA-PREVENTION, RF-OCC-BENZENE-MALIGNANCY-PREVENTION, RF-OCC-FORMALDEHYDE-PREVENTION, RF-OCC-IONIZING-RADIATION-PREVENTION, RF-OCC-PAINTERS-PREVENTION

Technical MDT skill metadata (1/16 activated in this plan)

All registered virtual specialists. ✓ — activated for this case; ○ — not activated (available for other clinical scenarios).

Specialist	skill_id	Version	Last reviewed	Domain
Cellular therapy specialist (CAR-T)	`cellular_therapy_specialist`	v0.1.0	2026-04-25	cellular_therapy
Clinical pharmacist	`clinical_pharmacist`	v0.1.0	2026-04-25	clinical_pharmacy
Hematologist / oncohematologist	`hematologist`	v0.1.0	2026-04-25	hematology_oncology
Hematopathologist (lymphoma / leukemia / myeloma)	`hematopathologist`	v0.1.0	2026-04-25	hematopathology
Infectious disease / hepatology	`infectious_disease_hepatology`	v0.1.0	2026-04-25	infectious_diseases
Medical oncologist (solid-tumor chemotherapist)	`medical_oncologist`	v0.1.0	2026-04-25	solid_oncology
Molecular geneticist / molecular oncologist	`molecular_geneticist`	v0.1.0	2026-04-25	molecular_oncology
Palliative care	`palliative_care`	v0.1.0	2026-04-25	palliative_care
Pathologist (general)	`pathologist`	v0.1.0	2026-04-25	pathology
Primary care / family physician	`primary_care`	v0.1.0	2026-04-25	primary_care
Psycho-oncologist	`psychologist`	v0.1.0	2026-04-25	psychosocial
Radiation oncologist	`radiation_oncologist`	v0.1.0	2026-04-25	radiation_oncology
Radiologist	`radiologist`	v0.1.0	2026-04-25	diagnostic_imaging
Social worker / case manager	`social_worker_case_manager`	v0.1.0	2026-04-25	psychosocial
Surgical oncologist	`surgical_oncologist`	v0.1.0	2026-04-25	surgical_oncology
Transplant specialist (BMT)	`transplant_specialist`	v0.1.0	2026-04-25	cellular_therapy

Sources cited

SRC-ADMIRAL-PERL-2019: Gilteritinib or Chemotherapy for Relapsed or Refractory FLT3-Mutated AML (2019)
SRC-ELN-AML-2022: Diagnosis and management of AML in adults: 2022 ELN recommendations from an international expert panel (2022)
SRC-ESMO-AML-2020: Acute myeloid leukaemia in adult patients: ESMO Clinical Practice Guidelines for diagnosis, treatment and follow-up (2020)
SRC-NCCN-AML-2025: NCCN Clinical Practice Guidelines in Oncology: Acute Myeloid Leukemia (v.X.2025)

Experimental options (clinical trials)

Third plan track — open-enrollment trials from ClinicalTrials.gov. Render-time metadata; engine selection is not affected by this block (CHARTER §8.3). Last synced: 2026-06-27.

NCT	Title	Phase	Status	Sponsor	UA	Signals
NCT06672146	Comparing New Treatments for People With Newly Diagnosed Acute Myeloid Leukemia That Has an IDH2 Gene Change (A MyeloMATCH Treatment Trial)	PHASE2	RECRUITING	National Cancer Institute (NCI)	—	—
NCT04195633	Donor Stem Cell Transplant With Treosulfan, Fludarabine, and Total-Body Irradiation for the Treatment of Hematological Malignancies	PHASE2	RECRUITING	Fred Hutchinson Cancer Center	—	Single country
NCT06668558	Venetoclax + Azacitidine in Patients With Acute Myeloid Leukemia	PHASE2	RECRUITING	Grupo Cooperativo de Estudio y Tratamiento de las Leucemias Agudas y Mielodisplasias	—	Small N (<50) Single country
NCT04493164	CPX-351 and Ivosidenib for the Treatment of IDH1 Mutated Acute Myeloid Leukemia or High-Risk Myelodysplastic Syndrome	PHASE2	RECRUITING	M.D. Anderson Cancer Center	—	Small N (<50) Surrogate endpoint only Single country
NCT07604064	A Clinical Trial of Olutasidenib in Patients With Acute Myeloid Leukemia	PHASE2	RECRUITING	Kissei Pharmaceutical Co., Ltd.	—	Small N (<50) Single country
NCT06899581	Gut Health in Children With Cancer	N/A	RECRUITING	Great Ormond Street Hospital for Children NHS Foundation Trust	—	Small N (<50) Single country
NCT03128034	211^At-BC8-B10 Before Donor Stem Cell Transplant in Treating Patients With High-Risk Acute Myeloid Leukemia, Acute Lymphoblastic Leukemia, Myelodysplastic Syndrome, or Mixed-Phenotype Acute Leukemia	PHASE1 / PHASE2	RECRUITING	Fred Hutchinson Cancer Center	—	Single country
NCT05603884	VCA Regimen Followed by D-MAG Regimen on the Treatment of Elderly Patients With Newly Diagnosed Acute Myeloid Leukemia (AML)	PHASE2	RECRUITING	The First Affiliated Hospital of Xiamen University	—	Single country
NCT04282187	Decitabine With Ruxolitinib, Fedratinib or Pacritinib for the Treatment of Accelerated/Blast Phase Myeloproliferative Neoplasms	PHASE2	RECRUITING	University of Washington	—	Small N (<50) Single country
NCT05431257	Azacitidine in Combination With Low Dose Intensity Venetoclax in Patients With AML Incl. Explorative AML Profiling	PHASE2	RECRUITING	Rigshospitalet, Denmark	—	Surrogate endpoint only Single country

Verify recruitment status directly with the trial site. ctgov data can lag behind current UA-site status.

Option availability in Ukraine

Per-track UA registration · NSZU · cost · access pathway. Render-time metadata; engine selection does not depend on these fields (CHARTER §8.3).

Option	UA registration	NSZU	Cost orientation	Access pathway
Aggressive plan Gilteritinib monotherapy for R/R FLT3-mutated AML (REG-GILTERITINIB-AML) 1/1 component drug(s) not registered in Ukraine +1	✗ not registered	✗ out-of-pocket	₴-? — verify pathway	not recorded
Aggressive plan Enasidenib monotherapy for R/R IDH2-mutated AML (REG-ENASIDENIB-AML) 1/1 component drug(s) not registered in Ukraine +1	✗ not registered	✗ out-of-pocket	₴-? — verify pathway	not recorded
Trial · NCT06672146 Comparing New Treatments for People With Newly Diagnosed Acute Myeloid Leukemia That Has an IDH2 Gene Change (A MyeloMATCH Treatment Trial) No UA site listed — international referral required	— unknown	— unknown	self-pay: ₴0/course	Trial sponsor
Trial · NCT04195633 Donor Stem Cell Transplant With Treosulfan, Fludarabine, and Total-Body Irradiation for the Treatment of Hematological Malignancies No UA site listed — international referral required	— unknown	— unknown	self-pay: ₴0/course	Trial sponsor
Trial · NCT06668558 Venetoclax + Azacitidine in Patients With Acute Myeloid Leukemia No UA site listed — international referral required	— unknown	— unknown	self-pay: ₴0/course	Trial sponsor
Trial · NCT04493164 CPX-351 and Ivosidenib for the Treatment of IDH1 Mutated Acute Myeloid Leukemia or High-Risk Myelodysplastic Syndrome No UA site listed — international referral required	— unknown	— unknown	self-pay: ₴0/course	Trial sponsor
Trial · NCT07604064 A Clinical Trial of Olutasidenib in Patients With Acute Myeloid Leukemia No UA site listed — international referral required	— unknown	— unknown	self-pay: ₴0/course	Trial sponsor
Trial · NCT06899581 Gut Health in Children With Cancer No UA site listed — international referral required	— unknown	— unknown	self-pay: ₴0/course	Trial sponsor
Trial · NCT03128034 211^At-BC8-B10 Before Donor Stem Cell Transplant in Treating Patients With High-Risk Acute Myeloid Leukemia, Acute Lymphoblastic Leukemia, Myelodysplastic Syndrome, or Mixed-Phenotype Acute Leukemia No UA site listed — international referral required	— unknown	— unknown	self-pay: ₴0/course	Trial sponsor
Trial · NCT05603884 VCA Regimen Followed by D-MAG Regimen on the Treatment of Elderly Patients With Newly Diagnosed Acute Myeloid Leukemia (AML) No UA site listed — international referral required	— unknown	— unknown	self-pay: ₴0/course	Trial sponsor
Trial · NCT04282187 Decitabine With Ruxolitinib, Fedratinib or Pacritinib for the Treatment of Accelerated/Blast Phase Myeloproliferative Neoplasms No UA site listed — international referral required	— unknown	— unknown	self-pay: ₴0/course	Trial sponsor
Trial · NCT05431257 Azacitidine in Combination With Low Dose Intensity Venetoclax in Patients With AML Incl. Explorative AML Profiling No UA site listed — international referral required	— unknown	— unknown	self-pay: ₴0/course	Trial sponsor

Cost information is orientation. Verify with a specific pharmacy / foundation / trial site. Status updated: 2026-06-27.

plan_id: PLAN-AML-RR-GILT-FLT3TKD-001-V1 | version: 1 | generated: 2026-06-27T09:41:02.883861+00:00

Per FDA non-device CDS positioning (CHARTER §15): Outpatient oncology treatment planning to support tumor-board discussion. Not a medical device; not for autonomous clinical decision-making.

Per FDA non-device CDS positioning (CHARTER §15): Both treatment options below are presented for review. The engine's selection of a 'recommended' default does not constitute a clinical decision. Final treatment selection requires HCP judgment incorporating information not available to the system.

This document is an informational resource supporting tumor-board discussion (per CHARTER §11). It is not a system that makes clinical decisions. Every recommendation must be verified by the treating physician.