OpenOnco · Treatment Plan

Treatment plan — Acute Promyelocytic Leukemia

PLAN-VAR-APL-BIOMARK-V1 · v1 · 2026-05-12

Patient

VAR-APL-BIOMARK · 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 4.

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

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 (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-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 (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-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: 2026-05-12.

NCT	Title	Phase	Status	Sponsor	UA	Signals
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
NCT05832320	Optimum Induction Therapy of Low-risk APL	NA	RECRUITING	Peking University People's Hospital	—	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
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
NCT04687176	Frontline Oral Arsenic Trioxide for APL	PHASE2	RECRUITING	The University of Hong Kong	—	—
NCT04793919	Treatment Study for Children and Adolescents With Acute Promyelocytic Leukemia	PHASE2	RECRUITING	Associazione Italiana Ematologia Oncologia Pediatrica	—	—
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
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
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
NCT07504458	Pivotal Open-label Phase 3 Clinical Study of QTX-2101 in Adult Patients With Acute Promyelocytic Leukemia	PHASE3	RECRUITING	Quetzal Therapeutics	—	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
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 · 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 · NCT05832320 Optimum Induction Therapy of Low-risk APL 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 · 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 · NCT04687176 Frontline Oral Arsenic Trioxide for APL 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
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 · 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 · 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 · 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

Cost information is orientation. Verify with a specific pharmacy / foundation / trial site. Status updated: 2026-05-12.

plan_id: PLAN-VAR-APL-BIOMARK-V1 | version: 1 | generated: 2026-05-12T18:41:26.214550+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.