OpenOnco · Treatment Plan

Treatment plan — Chronic Myeloid Leukemia

PLAN-CML-BC-PRESENT-001-V1 · v1 · 2026-09-09

Patient

CML-BC-PRESENT-001 · Algorithm: ALGO-CML-1L

DiagnosisChronic Myeloid Leukemia

MOH / ICD-10C92.1

ICD-O-39863/3; C42.1

Etiological driver

Etiological driver · etiologically_driven archetype

Chronic Myeloid Leukemia

BCR-ABL1 fusion arising from t(9;22)(q34;q11.2) (Philadelphia chromosome) in 100% — defining + targetable driver
p210 (Major BCR breakpoint, e13a2 / e14a2): classic CML (>95%)
p190 (minor BCR, e1a2): more often Ph+ ALL, occasionally lymphoid-blast-phase CML
p230 (micro BCR, e19a2): rare, indolent neutrophilic CML
Sporadic; rare environmental association (ionizing radiation)

Clinical significance of mutations (ESCAT)

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

✅ Covered biomarkers (matched in KB)

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

⚠️ Not included in plan

Biomarker	Status
BCR-ABL1	Not in KB — ask clinician to verify

Primary current-line option

Standard plan

★ DEFAULT

Indication

IND-CML-1L-IMATINIB

Regimen

Imatinib (CML chronic phase 1L)

Drugs + NSZU

Imatinib (DRUG-IMATINIB) 400 mg PO once daily with food + large glass of water · continuous, lifelong (or until durable deep molecular response permits TFR attempt per ELN 2020 criteria) · PO ✓ NSZU covered

Reason

Primary current-line option selected by ALGO-CML-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-CML-1L-2GEN-TKI

Regimen

2nd-generation TKI (dasatinib OR nilotinib OR bosutinib by comorbidity matrix) — CML chronic phase 1L for high-risk / younger seeking TFR

Drugs + NSZU

Dasatinib (DRUG-DASATINIB) 100 mg PO once daily — DEFAULT for low-CV-risk; AVOID if pulmonary disease · continuous; lifelong unless TFR achieved · PO ✓ NSZU covered
Nilotinib (DRUG-NILOTINIB) 300 mg PO BID on empty stomach (≥1 h before / ≥2 h after meals) — DEFAULT for low-CV-risk + no pancreatitis history; AVOID if CV disease, DM, hyperlipidemia · continuous · PO ✓ NSZU covered
Bosutinib (DRUG-BOSUTINIB) 400 mg PO once daily with food — for patients with CV comorbidity precluding nilotinib AND pulmonary precluding dasatinib · continuous · PO ✓ NSZU covered

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-BCR-ABL-JAK2	BCR-ABL + JAK2 + CALR + MPL	Critical	genomic	CSD Lab ✓ (code TBC)	all tracks
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-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-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-PREGNANCY	Beta-HCG	Critical	lab	—	all tracks
TEST-ECHO	Echocardiography	Standard	imaging	—	aggressive

Red flags — PRO / CONTRA aggressive

PRO-AGGRESSIVE

Triggers that push toward the aggressive track

CML high-risk by ELTS (EUTOS Long-Term Survival score) — favors 2nd-generation TKI (nilotinib / dasatinib / bosutinib) over imatinib for faster deep molecular response and improved long-term outcomes
ELN 2020 prefers ELTS over Sokal for predicting CML-related death and guiding 1L TKI selection in younger patients seeking treatment-free remission. High-risk patients gain more from 2nd-gen TKIs in early deep molecular response, but no…
RF-CML-HIGH-RISK-ELTSSRC-NCCN-MPN-2025SRC-ELN-CML-2020SRC-ESMO-CML-2017
CML patient with comorbidity excluding specific 2nd-gen TKIs: significant cardiovascular disease (PAOD, prior MI/stroke, uncontrolled HTN — avoid nilotinib/ponatinib), pulmonary disease (COPD, prior pleural disease — avoid dasatinib), severe GI disease (avoid bosutinib), pancreatitis history (avoid nilotinib)
Direction "investigate" — surfaces comorbidity-matched TKI choice as a supplementary annotation rather than a binary indication switch. ELN 2020 comorbidity matrix: - CV disease / hyperlipidemia / DM → AVOID nilotinib + ponatinib…
RF-CML-ORGAN-DYSFUNCTIONSRC-NCCN-MPN-2025SRC-ELN-CML-2020
CML with T315I gatekeeper mutation in the BCR-ABL1 kinase domain — resistant to all 1st/2nd-gen TKIs; requires ponatinib or asciminib (STAMP)
T315I emergence on imatinib / 2nd-gen TKI mandates switch to ponatinib (full-dose 45 mg → response-adjusted to 15 mg per OPTIC) or asciminib STAMP (response rates ~50% in T315I-positive). Both NOT registered in Ukraine — major access…
RF-CML-T315I-MUTATIONSRC-NCCN-MPN-2025SRC-ELN-CML-2020
CML in accelerated or blast phase: ≥10% blasts in PB or BM (accelerated), ≥20% blasts (blast phase), or extramedullary blasts. Treatment intent shifts from chronic-phase TKI to acute-leukemia-style induction + alloHCT.
Triggers HOLD on chronic-phase 1L algorithm. Accelerated/blast-phase CML is a clinical emergency: high-dose 2nd/3rd-gen TKI (dasatinib 140 mg or ponatinib if T315I), urgent donor search for alloHCT, induction chemotherapy (myeloid blast…
RF-CML-TRANSFORMATION-PROGRESSIONSRC-NCCN-MPN-2025SRC-ELN-CML-2020SRC-ESMO-CML-2017
CML chronic phase with Hasford (EURO) high risk — supports 2nd-generation TKI 1L (dasatinib / nilotinib / bosutinib) over imatinib; comparable rationale to Sokal-high
Hasford / EURO score (Hasford 1998) refined Sokal by adding eosinophils and basophils; high-risk = >1480. Hasford-high and Sokal-high overlap substantially but identify slightly different subsets. ELN 2020 recognizes both alongside the…
RF-HASFORD-HIGHSRC-NCCN-MPN-2025SRC-ELN-CML-2020SRC-ESMO-CML-2017
CML chronic phase with Sokal high risk — supports 2nd-generation TKI 1L (dasatinib / nilotinib / bosutinib) over imatinib for faster MMR/MR4.5 and improved long-term cumulative incidence of progression
Sokal score (Sokal 1984) uses age, spleen size, platelet count, blast %. High-risk (Sokal >1.2) marks ~20-25% of CML-CP at diagnosis with worse 10-yr OS and PFS on imatinib vs intermediate/low. ENESTnd (Saglio 2010) and DASISION…
RF-SOKAL-HIGHSRC-NCCN-MPN-2025SRC-ELN-CML-2020SRC-ESMO-CML-2017

CONTRA-AGGRESSIVE

Hard contraindications to escalation

What NOT to do

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

Standard plan (IND-CML-1L-IMATINIB)

Do not skip baseline BCR-ABL1 quantitative PCR — this is baseline for milestone monitoring.
Do not skip pre-TKI HBV screening — HBV reactivation on TKI has been described in cases.
Do not skip the fertility discussion in young patients — TKI safety during pregnancy is limited; interferon-α — alternative at conception.
Do not prescribe without food + a large glass of water — GI intolerance on empty stomach.
Do not repeat imatinib 400 mg on failure — switch per ELN criteria (3 mo / 6 mo / 12 mo) to a 2nd-gen TKI.
Do not start a TFR attempt without ≥3 years of TKI + sustained MR4.5 ≥2 years + qPCR monitoring q1-2mo after stopping.

Aggressive plan (IND-CML-1L-2GEN-TKI)

Do not prescribe nilotinib without baseline CV evaluation + ECG + lipid panel + glucose — boxed QT warning + cumulative vascular toxicity.
Do not prescribe dasatinib to patients with pulmonary comorbidity / prior pleural effusion — risk of severe effusion.
Do not prescribe bosutinib to patients with IBD / severe diarrhea history — diarrhea ~70% risk.
Do not skip pre-TKI HBV screening.
Do not skip the fertility discussion; TKI safety during pregnancy is limited.
Do not start without food for bosutinib (with food); STRICTLY on empty stomach for nilotinib (≥1h before / ≥2h after).

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-CML-COMORBIDITY-COMPLEX, RF-CML-FRAILTY-AGE, RF-CML-HIGH-RISK-ELTS, RF-CML-INFECTION-SCREENING, RF-CML-ORGAN-DYSFUNCTION, RF-CML-T315I-MUTATION, RF-CML-TRANSFORMATION-PROGRESSION, RF-HASFORD-HIGH, RF-SOKAL-HIGH

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-ELN-CML-2020: European LeukemiaNet 2020 recommendations for treating chronic myeloid leukemia (2020)
SRC-ESMO-CML-2017: Chronic myeloid leukaemia: ESMO Clinical Practice Guidelines for diagnosis, treatment and follow-up (2017)
SRC-IRIS-OBRIEN-2003: Imatinib compared with interferon and low-dose cytarabine for newly diagnosed chronic-phase chronic myeloid leukemia (2003)
SRC-NCCN-MPN-2025: NCCN Clinical Practice Guidelines in Oncology: Myeloproliferative Neoplasms (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: 2026-09-09.

NCT	Title	Phase	Status	Sponsor	UA	Signals
NCT06787144	ELVN-001 for the Treatment of Chronic Myeloid Leukemia With and Without T315I Mutation in Japanese Participants	PHASE1	RECRUITING	Enliven Therapeutics	—	Phase 1 only Small N (<50) Single country
NCT06163430	A Phase 1/2 Clinical Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Efficacy of TERN-701 in Participants With Chronic Myeloid Leukemia (CARDINAL)	PHASE1 / PHASE2	RECRUITING	Terns, Inc., a subsidiary of Merck & Co., Inc. (Rahway, New Jersey USA)	—	—
NCT06712810	Q702 for the Treatment of Patients With Hematologic Malignancies	PHASE1	RECRUITING	Mayo Clinic	—	Phase 1 only Small N (<50) Surrogate endpoint only Single country
NCT03896269	CPX-351 in Treating Patients With Relapsed or Refractory High Risk Myelodysplastic Syndrome or Chronic Myelomonocytic Leukemia	PHASE1	RECRUITING	M.D. Anderson Cancer Center	—	Phase 1 only Small N (<50) Surrogate endpoint only Single country
NCT04877522	Asciminib Roll-over Study	PHASE4	RECRUITING	Novartis Pharmaceuticals	—	—
NCT04769947	Italian Treatment Free Remission Registry	N/A	RECRUITING	University of Turin, Italy	—	Single country
NCT05807932	Venetoclax in Addition to Sequential Conditioning With Fludarabine / Amsacrine / Ara-C (FLAMSA) + Treosulfan for Allogeneic Blood Stem Cell Transplantation in Patients With MDS, CMML or sAML	PHASE1 / PHASE2	RECRUITING	Heinrich-Heine University, Duesseldorf	—	Small N (<50) Single country
NCT01137825	Registry of Older Patients With Cancer	N/A	RECRUITING	UNC Lineberger Comprehensive Cancer Center	—	Single country
NCT02115295	Cladribine, Idarubicin, Cytarabine, and Venetoclax in Treating Patients With Acute Myeloid Leukemia, High-Risk Myelodysplastic Syndrome, or Blastic Phase Chronic Myeloid Leukemia	PHASE2	RECRUITING	M.D. Anderson Cancer Center	—	Single country
NCT02333604	Cancer Experience Registry (CER) for Cancer Patients and Caregivers	N/A	RECRUITING	Cancer Support Community, Research and Training Institute, Philadelphia	—	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 Imatinib (CML chronic phase 1L) (REG-IMATINIB-CML)	✓ registered	✓ covered	₴-? — verify pathway	NSZU formulary
Aggressive plan 2nd-generation TKI (dasatinib OR nilotinib OR bosutinib by comorbidity matrix) — CML chronic phase 1L for high-risk / younger seeking TFR (REG-2GEN-TKI-CML)	✓ registered	✓ covered	₴-? — verify pathway	NSZU formulary
Trial · NCT06787144 ELVN-001 for the Treatment of Chronic Myeloid Leukemia With and Without T315I Mutation in Japanese Participants No UA site listed — international referral required	— unknown	— unknown	self-pay: ₴0/course	Trial sponsor
Trial · NCT06163430 A Phase 1/2 Clinical Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Efficacy of TERN-701 in Participants With Chronic Myeloid Leukemia (CARDINAL) No UA site listed — international referral required	— unknown	— unknown	self-pay: ₴0/course	Trial sponsor
Trial · NCT06712810 Q702 for the Treatment of Patients With Hematologic Malignancies No UA site listed — international referral required	— unknown	— unknown	self-pay: ₴0/course	Trial sponsor
Trial · NCT03896269 CPX-351 in Treating Patients With Relapsed or Refractory High Risk Myelodysplastic Syndrome or Chronic Myelomonocytic Leukemia No UA site listed — international referral required	— unknown	— unknown	self-pay: ₴0/course	Trial sponsor
Trial · NCT04877522 Asciminib Roll-over Study No UA site listed — international referral required	— unknown	— unknown	self-pay: ₴0/course	Trial sponsor
Trial · NCT04769947 Italian Treatment Free Remission Registry No UA site listed — international referral required	— unknown	— unknown	self-pay: ₴0/course	Trial sponsor
Trial · NCT05807932 Venetoclax in Addition to Sequential Conditioning With Fludarabine / Amsacrine / Ara-C (FLAMSA) + Treosulfan for Allogeneic Blood Stem Cell Transplantation in Patients With MDS, CMML or sAML No UA site listed — international referral required	— unknown	— unknown	self-pay: ₴0/course	Trial sponsor
Trial · NCT01137825 Registry of Older Patients With Cancer No UA site listed — international referral required	— unknown	— unknown	self-pay: ₴0/course	Trial sponsor
Trial · NCT02115295 Cladribine, Idarubicin, Cytarabine, and Venetoclax in Treating Patients With Acute Myeloid Leukemia, High-Risk Myelodysplastic Syndrome, or Blastic Phase Chronic Myeloid Leukemia No UA site listed — international referral required	— unknown	— unknown	self-pay: ₴0/course	Trial sponsor
Trial · NCT02333604 Cancer Experience Registry (CER) for Cancer Patients and Caregivers 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: 2026-09-09.

plan_id: PLAN-CML-BC-PRESENT-001-V1 | version: 1 | generated: 2026-09-09T12:26:41.361927+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.