OpenOnco · Treatment Plan

Treatment plan — Acute Myeloid Leukemia

PLAN-AML-RR-GILT-FLT3TKD-001-V1 · v1 · 2026-05-12

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

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: 2026-05-12.

NCT	Title	Phase	Status	Sponsor	UA	Signals
NCT06616636	A Phase Ib Study of Rezatapopt in Combination With Azacitidine in Patients With TP53Y220C Mutant Myeloid Malignancies (Acute Myeloid Leukemia or Myelodysplastic Syndrome)	PHASE1	RECRUITING	M.D. Anderson Cancer Center	—	Phase 1 only Small N (<50) Single country
NCT05241093	A Study of HYML-122 and Cytarabine in Patients With FLT3 Positive Relapsed or Refractory Acute Myeloid Leukemia (AML)	PHASE2	RECRUITING	Tarapeutics Science Inc.	—	Small N (<50) Surrogate endpoint only Single country
NCT06541444	Safety and Efficacy of NK520 to Treat Relapsed/Refractory Acute Myeloid Leukemia	EARLY_PHASE1	RECRUITING	Base Therapeutics (Shanghai) Co., Ltd.	—	Small N (<50) Surrogate endpoint only Single country
NCT05326919	The Patient Cohort of the National Center for Precision Medicine in Leukemia	N/A	RECRUITING	Assistance Publique - Hôpitaux de Paris	—	Single country
NCT05260528	CPX-351 vs Intensive Chemotherapy in Patients With de Novo Intermediate or Adverse Risk AML Stratified by Genomics	PHASE2	RECRUITING	Centre Hospitalier Universitaire de Nice	—	Single country
NCT05554406	Testing the Effects of Novel Therapeutics for Newly Diagnosed, Untreated Patients With High-Risk Acute Myeloid Leukemia (A MyeloMATCH Treatment Trial)	PHASE2	RECRUITING	National Cancer Institute (NCI)	—	—
NCT06580106	Toxicity Genetic Determinants and Response to Azacitidine and Venetoclax in AML	N/A	RECRUITING	Wake Forest University Health Sciences	—	Single country
NCT05105152	PLAT-08: A Study Of SC-DARIC33 CAR T Cells In Pediatric And Young Adults With Relapsed Or Refractory CD33+ AML	PHASE1	RECRUITING	Seattle Children's Hospital	—	Phase 1 only Small N (<50) Single country
NCT06125652	Administration of Anti Tim-3/CD123 CAR-T Cell Therapy in Relapsed and Refractory Acute Myeloid Leukemia (rr/AML)	PHASE1 / PHASE2	RECRUITING	Xuzhou Medical University	—	Small N (<50) Single country
NCT04243785	A Study of BTX-A51 in People With Relapsed or Refractory Acute Myeloid Leukemia or High-Risk Myelodysplastic Syndrome	PHASE1	RECRUITING	Edgewood Oncology Inc.	—	Phase 1 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 · NCT06616636 A Phase Ib Study of Rezatapopt in Combination With Azacitidine in Patients With TP53Y220C Mutant Myeloid Malignancies (Acute Myeloid Leukemia or Myelodysplastic Syndrome) No UA site listed — international referral required	— unknown	— unknown	self-pay: ₴0/course	Trial sponsor
Trial · NCT05241093 A Study of HYML-122 and Cytarabine in Patients With FLT3 Positive Relapsed or Refractory Acute Myeloid Leukemia (AML) No UA site listed — international referral required	— unknown	— unknown	self-pay: ₴0/course	Trial sponsor
Trial · NCT06541444 Safety and Efficacy of NK520 to Treat Relapsed/Refractory Acute Myeloid Leukemia No UA site listed — international referral required	— unknown	— unknown	self-pay: ₴0/course	Trial sponsor
Trial · NCT05326919 The Patient Cohort of the National Center for Precision Medicine in Leukemia No UA site listed — international referral required	— unknown	— unknown	self-pay: ₴0/course	Trial sponsor
Trial · NCT05260528 CPX-351 vs Intensive Chemotherapy in Patients With de Novo Intermediate or Adverse Risk AML Stratified by Genomics No UA site listed — international referral required	— unknown	— unknown	self-pay: ₴0/course	Trial sponsor
Trial · NCT05554406 Testing the Effects of Novel Therapeutics for Newly Diagnosed, Untreated Patients With High-Risk Acute Myeloid Leukemia (A MyeloMATCH Treatment Trial) No UA site listed — international referral required	— unknown	— unknown	self-pay: ₴0/course	Trial sponsor
Trial · NCT06580106 Toxicity Genetic Determinants and Response to Azacitidine and Venetoclax in AML No UA site listed — international referral required	— unknown	— unknown	self-pay: ₴0/course	Trial sponsor
Trial · NCT05105152 PLAT-08: A Study Of SC-DARIC33 CAR T Cells In Pediatric And Young Adults With Relapsed Or Refractory CD33+ AML No UA site listed — international referral required	— unknown	— unknown	self-pay: ₴0/course	Trial sponsor
Trial · NCT06125652 Administration of Anti Tim-3/CD123 CAR-T Cell Therapy in Relapsed and Refractory Acute Myeloid Leukemia (rr/AML) No UA site listed — international referral required	— unknown	— unknown	self-pay: ₴0/course	Trial sponsor
Trial · NCT04243785 A Study of BTX-A51 in People With Relapsed or Refractory Acute Myeloid Leukemia or High-Risk Myelodysplastic Syndrome 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: 2026-05-12.

plan_id: PLAN-AML-RR-GILT-FLT3TKD-001-V1 | version: 1 | generated: 2026-05-12T18:41:26.916191+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.