OpenOnco · Treatment Plan

Treatment plan — Acute Promyelocytic Leukemia

PLAN-VAR-APL-FRAIL-V1 · v1 · 2026-05-13

Patient

VAR-APL-FRAIL · Algorithm: ALGO-APL-1L

DiagnosisAcute Promyelocytic Leukemia

MOH / ICD-10C92.4

ICD-O-39866/3; 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

Standard plan

★ DEFAULT

Indication

IND-APL-1L-ATRA-ATO

Regimen

ATRA + Arsenic Trioxide (APL low/intermediate-risk) — APL0406 / LO-CoCo schedule

Drugs + NSZU

All-trans retinoic acid (DRUG-ATRA) 45 mg/m²/day PO (divided BID with food) · continuous from day 1 until complete remission (~28-50 days induction); then 2 weeks q4w × 7 cycles consolidation · PO ✓ NSZU covered
Arsenic trioxide (DRUG-ATO) 0.15 mg/kg/day · IV daily until CR (~28-35 days induction); then 5 d/wk × 4 wk q8w × 4 cycles consolidation · IV ✓ NSZU covered

Supportive care

SUP-HBV-PROPHYLAXIS, SUP-HSV-PROPHYLAXIS

Reason

Primary current-line option selected by ALGO-APL-1L at step 3; branch-driving red flag: RF-APL-FRAILTY-AGE.

Other current-line alternatives (1 tracks)

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

Aggressive plan

Indication

IND-APL-1L-ATRA-ATO-IDA

Regimen

ATRA + ATO + Idarubicin (APL high-risk) — modified APL0406 / AIDA-style

Drugs + NSZU

All-trans retinoic acid (DRUG-ATRA) 45 mg/m²/day PO (divided BID with food) · continuous from day 1 until CR; then per consolidation · PO ✓ NSZU covered
Arsenic trioxide (DRUG-ATO) 0.15 mg/kg/day · IV daily until CR; then per consolidation · IV ✓ NSZU covered
Idarubicin (DRUG-IDARUBICIN) 12 mg/m² · IV days 2, 4, 6, 8 (4 doses during induction) · IV ✓ NSZU covered

Supportive care

SUP-TLS-PROPHYLAXIS, SUP-HBV-PROPHYLAXIS, SUP-HSV-PROPHYLAXIS

Hard contraindications

CI-LVEF-LOW-FOR-ANTHRACYCLINE

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 3 → branch IND-APL-1L-ATRA-ATO

RF-APL-FRAILTY-AGE ★ winner: APL patient elderly (age ≥70) or frail (ECOG ≥2 with comorbidities) — chemo-free ATRA + ATO is preferred even for high-risk if anthracycline tolerance is concerning; toxicity profile of AIDA poorly tolerated >70 SRC-NCCN-AML-2025SRC-ELN-APL-2019

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-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	—	all tracks
TEST-ECHO	Echocardiography	Standard	imaging	—	all tracks
TEST-URIC-ACID	Serum Uric Acid	Standard	lab	—	aggressive
TEST-D-DIMER	D-Dimer	Desired	lab	—	all tracks

Red flags — PRO / CONTRA aggressive

PRO-AGGRESSIVE

Triggers that push toward the aggressive track

APL with active disseminated intravascular coagulation (DIC): fibrinogen <150 mg/dL, prolonged PT/PTT, elevated D-dimer, thrombocytopenia + bleeding manifestations. Initiate ATRA AT CLINICAL SUSPICION before cytogenetic confirmation.RF-APL-EMERGENCY-DIC
APL high-risk by Sanz score: presenting WBC >10 K/μL — requires anthracycline addition (idarubicin) to ATRA + ATO (or AIDA-style) rather than chemo-free ATRA + ATORF-APL-HIGH-RISK-BIOLOGY
APL with cardiac comorbidity making ATO problematic: baseline QTc >500 ms, uncorrected hypokalemia (<3.5) or hypomagnesemia (<1.8), pre-existing arrhythmia OR severe hepatic dysfunction (bilirubin >3× ULN, transaminases >5× ULN)RF-APL-ORGAN-DYSFUNCTION
APL with Sanz high risk — WBC >10 ×10^9/L at diagnosis — supports ATRA+ATO+idarubicin (or +gemtuzumab in selected protocols); higher early-death risk and warrants leukapheresis-avoidance + aggressive DIC managementRF-SANZ-HIGH-RISK

CONTRA-AGGRESSIVE

Hard contraindications to escalation

Pre-treatment LVEF <50% is an absolute contraindication to anthracycline-containing regimens (R-CHOP, Pola-R-CHP, ABVD, BV-AVD, etc.). Cardiotoxicity from doxorubicin is dose-cumulative and often irreversible; starting with already-impaired function risks acute decompensation.CI-LVEF-LOW-FOR-ANTHRACYCLINE

What NOT to do

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

Standard plan (IND-APL-1L-ATRA-ATO)

Do not wait for cytogenetic confirmation of PML-RARα to start ATRA — clinical suspicion + typical smear/DIC = immediate ATRA.
Do not skip DS prophylaxis with steroids on rising WBC during induction — DS is the leading cause of mortality in induction.
Do not start ATO without daily ECG + electrolyte correction (K+ >4.0, Mg2+ >1.8) — torsades risk.
Do not prescribe without ruling out pregnancy + 2 methods of contraception — ATRA and ATO are both teratogenic.
Do not prescribe an anthracycline-containing regimen if patient is low-risk (WBC ≤10) — APL0406 showed that chemo-free ATRA + ATO is better.
Do not skip DIC management at debut — fibrinogen target >150, plt target >30-50K, INR <1.5.

Aggressive plan (IND-APL-1L-ATRA-ATO-IDA)

Do not use chemo-free ATRA + ATO for high-risk APL (WBC >10) — APL0406 enrollment criterion excluded this population.
Do not skip DS prophylaxis with dexamethasone at high WBC at debut — DS is especially common in high-risk.
Do not skip DIC management — high-risk APL has the highest rate of bleeding-related early mortality.
Do not prescribe idarubicin without baseline LVEF + cumulative anthracycline tracking.
Do not skip hyperleukocytosis management (hydroxyurea ± leukapheresis) if WBC >100K at debut.

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 (3 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.
3	palliative_care	Specialist review	Reduced performance status / decompensated comorbidity — goals-of-care assessment needed.

Skills (recommended) — for consideration (2)

Clinical pharmacist recommended
Chemoimmunotherapy regimen — drug-drug interactions, dose adjustments, premedication.
Palliative care recommended
Reduced performance status / decompensated comorbidity — goals-of-care assessment needed.

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-APL-EMERGENCY-DIC, RF-APL-FRAILTY-AGE, RF-APL-HIGH-RISK-BIOLOGY, RF-APL-INFECTION-SCREENING, RF-APL-ORGAN-DYSFUNCTION, RF-APL-TRANSFORMATION-PROGRESSION, RF-SANZ-HIGH-RISK, RF-SANZ-INTERMEDIATE, RF-SANZ-LOW-RISK

Technical MDT skill metadata (2/16 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-APL0406-LOCOCO-2013: Retinoic acid and arsenic trioxide for acute promyelocytic leukemia (2013)
SRC-ELN-APL-2019: Management of acute promyelocytic leukemia: updated recommendations from an expert panel of the European LeukemiaNet (2019)
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: 2026-05-13.

NCT	Title	Phase	Status	Sponsor	UA	Signals
NCT02390635	PET/MRI, 18F-FDG PET/CT and Whole Body MRI in Finding Extramedullary Myeloid Leukemia in Patients With Newly Diagnosed Acute Myeloid Leukemia	PHASE1	RECRUITING	M.D. Anderson Cancer Center	—	Phase 1 only Single country
NCT04897490	RWE of 1st Line Treatment With ATO/ATRA for Adult APL	N/A	RECRUITING	Grupo Argentino de Tratamiento de la Leucemia Aguda	—	Single country
NCT05832320	Optimum Induction Therapy of Low-risk APL	NA	RECRUITING	Peking University People's Hospital	—	Single country
NCT05881265	Treatment of Chidamide and Venetoclax for Retinoic Acid and Arsenic Resistant Acute Promyelocytic Leukemia	PHASE2	RECRUITING	Shanghai Jiao Tong University School of Medicine	—	Small N (<50) Single country
NCT06450145	Evaluate the Efficacy and Safety of Interferon-α Combined With ATO in the Treatment of Arsenic-resistant APL	NA	RECRUITING	Zhejiang Provincial People's Hospital	—	Small N (<50) Surrogate endpoint only Single country
NCT02390752	Phase I Trial of TURALIO(R) (Pexidartinib, PLX3397) in Children and Young Adults With Refractory Leukemias and Refractory Solid Tumors Including Neurofibromatosis Type 1 (NF1) Associated Plexiform Neurofibromas (PN) and Tenosynovial Giant Cell Tumor ...	PHASE1	RECRUITING	National Cancer Institute (NCI)	—	Phase 1 only Single country
NCT06982274	Oral Arsenic With ATRA for Newly Diagnosed Patients With Acute Promyelocytic Leukemia	PHASE2	RECRUITING	Instituto do Cancer do Estado de São Paulo	—	Single country
NCT01409161	Tretinoin and Arsenic Trioxide With or Without Gemtuzumab Ozogamicin in Treating Patients With Previously Untreated Acute Promyelocytic Leukemia	PHASE2	RECRUITING	M.D. Anderson Cancer Center	—	Single country
NCT07504458	Pivotal Open-label Phase 3 Clinical Study of QTX-2101 in Adult Patients With Acute Promyelocytic Leukemia	PHASE3	RECRUITING	Quetzal Therapeutics	—	Single country
NCT04793919	Treatment Study for Children and Adolescents With Acute Promyelocytic Leukemia	PHASE2	RECRUITING	Associazione Italiana Ematologia Oncologia Pediatrica	—	—

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
Standard plan ATRA + Arsenic Trioxide (APL low/intermediate-risk) — APL0406 / LO-CoCo schedule (REG-ATRA-ATO-APL)	✓ registered	✓ covered	₴-? — verify pathway	NSZU formulary
Aggressive plan ATRA + ATO + Idarubicin (APL high-risk) — modified APL0406 / AIDA-style (REG-ATRA-ATO-IDA-APL)	✓ registered	✓ covered	₴-? — verify pathway	NSZU formulary
Trial · NCT02390635 PET/MRI, 18F-FDG PET/CT and Whole Body MRI in Finding Extramedullary Myeloid Leukemia in Patients With Newly Diagnosed Acute Myeloid Leukemia No UA site listed — international referral required	— unknown	— unknown	self-pay: ₴0/course	Trial sponsor
Trial · NCT04897490 RWE of 1st Line Treatment With ATO/ATRA for Adult APL No UA site listed — international referral required	— unknown	— unknown	self-pay: ₴0/course	Trial sponsor
Trial · NCT05832320 Optimum Induction Therapy of Low-risk APL No UA site listed — international referral required	— unknown	— unknown	self-pay: ₴0/course	Trial sponsor
Trial · NCT05881265 Treatment of Chidamide and Venetoclax for Retinoic Acid and Arsenic Resistant Acute Promyelocytic Leukemia No UA site listed — international referral required	— unknown	— unknown	self-pay: ₴0/course	Trial sponsor
Trial · NCT06450145 Evaluate the Efficacy and Safety of Interferon-α Combined With ATO in the Treatment of Arsenic-resistant APL No UA site listed — international referral required	— unknown	— unknown	self-pay: ₴0/course	Trial sponsor
Trial · NCT02390752 Phase I Trial of TURALIO(R) (Pexidartinib, PLX3397) in Children and Young Adults With Refractory Leukemias and Refractory Solid Tumors Including Neurofibromatosis Type 1 (NF1) Associated Plexiform Neurofibromas (PN) and Tenosynovial Giant Cell Tumor ... No UA site listed — international referral required	— unknown	— unknown	self-pay: ₴0/course	Trial sponsor
Trial · NCT06982274 Oral Arsenic With ATRA for Newly Diagnosed Patients With Acute Promyelocytic Leukemia No UA site listed — international referral required	— unknown	— unknown	self-pay: ₴0/course	Trial sponsor
Trial · NCT01409161 Tretinoin and Arsenic Trioxide With or Without Gemtuzumab Ozogamicin in Treating Patients With Previously Untreated Acute Promyelocytic Leukemia No UA site listed — international referral required	— unknown	— unknown	self-pay: ₴0/course	Trial sponsor
Trial · NCT07504458 Pivotal Open-label Phase 3 Clinical Study of QTX-2101 in Adult Patients With Acute Promyelocytic Leukemia No UA site listed — international referral required	— unknown	— unknown	self-pay: ₴0/course	Trial sponsor
Trial · NCT04793919 Treatment Study for Children and Adolescents With Acute Promyelocytic Leukemia 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: 2026-05-13.

plan_id: PLAN-VAR-APL-FRAIL-V1 | version: 1 | generated: 2026-05-13T10:01:51.675758+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.