Treatment plan — DIS-MCL

OpenOnco · Treatment Plan

PLAN-AUTO-MCL-001-V1 · v1 · 2026-04-27

Patient

AUTO-MCL-001 · Algorithm: ALGO-MCL-1L

Clinical significance of mutations (ESCAT / OncoKB)

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

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

Treatment options (2 tracks)

Standard plan

★ DEFAULT

Indication

IND-MCL-1L-BTKI-R

Regimen

Acalabrutinib + Rituximab (continuous BTKi + R)

Drugs + NSZU

Acalabrutinib (DRUG-ACALABRUTINIB) 100 mg PO BID continuous · PO twice daily until progression or intolerance · PO ⚠ NSZU — not for this indication
Rituximab (DRUG-RITUXIMAB) 375 mg/m² · IV weekly × 4 (induction), then every 8 weeks × 2 years · IV ✓ NSZU covered

Hard contraindications

CI-HBV-NO-PROPHYLAXIS

Reason

Engine default per algorithm ALGO-MCL-1L: {'step': 3, 'outcome': False, 'branch': {'result': 'IND-MCL-1L-BTKI-R'}, 'fired_red_flags': [], 'winner_red_flag': None}

Aggressive plan

Indication

IND-MCL-1L-INTENSIVE

Regimen

Intensive 1L MCL: alternating R-CHOP / R-DHAP × 6 cycles + autoSCT consolidation + R maintenance

Drugs + NSZU

Rituximab (DRUG-RITUXIMAB) 375 mg/m² · IV day 1 each cycle (R-CHOP + R-DHAP) · IV ✓ NSZU covered
Cyclophosphamide (DRUG-CYCLOPHOSPHAMIDE) 750 mg/m² · IV day 1 of R-CHOP cycles only · IV ⚠ NSZU — not for this indication
Doxorubicin (DRUG-DOXORUBICIN) 50 mg/m² · IV day 1 of R-CHOP cycles only · IV ✓ NSZU covered
Vincristine (DRUG-VINCRISTINE) 1.4 mg/m² (cap 2 mg) · IV day 1 of R-CHOP cycles only · IV ⚠ NSZU — not for this indication
Prednisone (DRUG-PREDNISONE) 100 mg · PO days 1-5 of R-CHOP cycles · PO ⚠ NSZU — not for this indication
Dexamethasone (DRUG-DEXAMETHASONE) 40 mg · IV days 1-4 of R-DHAP cycles only · IV ⚠ NSZU — not for this indication
Cytarabine (DRUG-CYTARABINE) 2 g/m² q12h · IV day 2 of R-DHAP cycles (HiDAC component) · IV ⚠ NSZU — not for this indication

Supportive care

SUP-PJP-PROPHYLAXIS, SUP-TLS-PROPHYLAXIS, SUP-ANTIEMETIC-PREMED

Hard contraindications

CI-HBV-NO-PROPHYLAXIS, CI-LVEF-LOW-FOR-ANTHRACYCLINE

Reason

Alternative track presented for HCP consideration

Pre-treatment investigations

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

ID	Name	Priority	Category	Needed for
TEST-BM-ASPIRATE	Аспірат кісткового мозку (цитологія + flow + цитогенетика + молекулярка)	Critical	histology	aggressive
TEST-BM-TREPHINE	Трепанобіопсія кісткового мозку (core-біопсія)	Critical	histology	aggressive
TEST-CBC	Загальний аналіз крові з лейкоцитарною формулою	Critical	lab	all tracks
TEST-CD20-IHC	Імуногістохімія CD20	Critical	histology	all tracks
TEST-CMP	Розширений біохімічний аналіз крові	Critical	lab	all tracks
TEST-FISH-PANEL	FISH-панель (специфічна для нозології)	Critical	genomic	all tracks
TEST-HBV-SEROLOGY	Серологія HBV: HBsAg, anti-HBc, anti-HBs	Critical	lab	all tracks
TEST-HCV-ANTIBODY	Антитіла до HCV	Critical	lab	aggressive
TEST-HIV-SEROLOGY	Серологія ВІЛ (антитіла HIV-1/2 + p24)	Critical	lab	all tracks
TEST-LDH	Лактатдегідрогеназа (ЛДГ)	Critical	lab	all tracks
TEST-LFT	Печінкові проби (АЛТ, АСТ, білірубін, ЛФ, ГГТП, альбумін)	Critical	lab	all tracks
TEST-LN-EXCISIONAL-BIOPSY	Ексцизійна біопсія лімфатичного вузла	Critical	histology	aggressive
TEST-PREGNANCY	β-ХГЛ (тест на вагітність)	Critical	lab	aggressive
TEST-B2-MICROGLOBULIN	Бета-2-мікроглобулін	Standard	lab	aggressive
TEST-ECHO	Ехокардіографія (ТТЕ) з оцінкою ФВ ЛШ	Standard	imaging	all tracks
TEST-PET-CT	ПЕТ/КТ із 18F-ФДГ	Standard	imaging	all tracks
TEST-NGS-LYMPHOID-PANEL	NGS-панель лімфоїдних мутацій	Desired	genomic	all tracks

Red flags — PRO / CONTRA aggressive

PRO-AGGRESSIVE

Triggers that push toward the aggressive track

Mantle cell lymphoma with MIPI low risk (MIPI <5.7 / 0-3 simplified points) — supports standard intensified induction in fit younger patients (Nordic / R-DHAP-based) without further treatment escalationRF-MIPI-LOW

CONTRA-AGGRESSIVE

Hard contraindications to escalation

Active or latent HBV without antiviral prophylaxis is an absolute contraindication to starting B-cell-depleting / immunomodulatory monoclonal antibody therapy (anti-CD20, anti-CD30 ADC, anti-CD38). Severe HBV reactivation hepatitis risk including fulminant hepatic failure.CI-HBV-NO-PROPHYLAXIS
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-MCL-1L-BTKI-R)

Не пропускати TP53 / Ki67 — TP53-mutant потребує consideration of CAR-T pathway and alloSCT consultation.
Не призначати без HBV скринінгу + prophylaxis при HBsAg+ / anti-HBc+.
Не комбінувати з warfarin без strict monitoring.
Не призначати при concomitant strong CYP3A4 inhibitor — hold inhibitor or dose-modify acalabrutinib.

Aggressive plan (IND-MCL-1L-INTENSIVE)

Не призначати в TP53-mutant або blastoid MCL — chemoimmuno-резистентний; прямий маршрут до BTKi-based (REG-ACALABRUTINIB-RITUXIMAB).
Не пропускати baseline LVEF + cytogenetics + TP53 sequencing перед стартом.
Не використовувати при age >65 OR ECOG >1 — toxicity overwhelms benefit; route to less intensive.
Не пропускати HBV скринінг + entecavir prophylaxis.
Не вводити вінкристин інтратекально — ФАТАЛЬНО.

Monitoring schedule

Monitoring schedule by treatment phase

Standard plan · MON-CLL-BTKI

Phase	Window	Tests	Checkpoints
baseline	Within 2 weeks before start	TEST-CBC, TEST-CMP, TEST-LFT, TEST-LDH, TEST-B2-MICROGLOBULIN, TEST-FISH-PANEL, TEST-NGS-LYMPHOID-PANEL, TEST-IMMUNOGLOBULINS, TEST-HBV-SEROLOGY, TEST-HCV-ANTIBODY, TEST-HIV-SEROLOGY, TEST-CECT-CAP, TEST-ECHO	Confirm CLL diagnosis: CD19+ CD5+ CD23+ flow on PB ≥5K monoclonal B-cells Risk stratification: del(17p), TP53, IGHV mutational status, karyotype iwCLL treatment indication documented (if asymptomatic — defer to surveillance) Cardiac baseline (atrial fibrillation history, hypertension control) HBV status + entecavir prophylaxis if HBsAg+ or anti-HBc+ (anti-CD20 in VenO regimen)
on_treatment_btki	Monthly × 3 months, then every 3 months	TEST-CBC, TEST-CMP, TEST-LFT	ALC trend (lymphocytosis early on BTKi is expected — not progression) Bleeding events; major bleed → hold BTKi AF symptoms → ECG; if AF → cardiology + anticoagulation strategy
on_treatment_veno	Per CLL14 schedule during 12-month VenO course	TEST-CBC, TEST-CMP, TEST-LFT, TEST-URIC-ACID	TLS labs (K+, phosphate, calcium, uric acid, creatinine) per ramp-up schedule ANC + platelets pre each obinutuzumab dose Infusion reactions to obinutuzumab (especially first dose)
response_assessment	After cycle 6 (VenO) or every 6 months on BTKi	TEST-CBC, TEST-CECT-CAP, TEST-FLOW-CYTOMETRY	iwCLL response criteria (CR, PR, PR-L on BTKi, SD, PD) MRD assessment by flow on PB at end of VenO 12-month course
follow_up	Every 3-6 months after treatment / continuously on BTKi	TEST-CBC, TEST-CMP, TEST-LFT	Surveillance for relapse (median PFS years for both regimens) Watch for Richter transformation (rapid LDH rise, new B-symptoms, isolated mass) — re-biopsy Second primary malignancy screening

Aggressive plan · MON-R-CHOP-REGIMEN

Phase	Window	Tests	Checkpoints
baseline	Within 2 weeks before cycle 1	TEST-CBC, TEST-CMP, TEST-LFT, TEST-LDH, TEST-B2-MICROGLOBULIN, TEST-HBV-SEROLOGY, TEST-HCV-ANTIBODY, TEST-HIV-SEROLOGY, TEST-PET-CT, TEST-LN-EXCISIONAL-BIOPSY, TEST-FLOW-CYTOMETRY, TEST-CD20-IHC, TEST-ECHO, TEST-PREGNANCY, TEST-BM-ASPIRATE, TEST-BM-TREPHINE	Confirm CD20+ DLBCL histology; rule out double-hit (FISH for MYC/BCL2/BCL6) Confirm HBV status + entecavir prophylaxis plan if HBsAg+ or anti-HBc+ Baseline LVEF ≥50% before doxorubicin IPI calculation documented (age, ECOG, LDH, stage, extranodal sites) CNS-IPI calculation if anatomic risk sites or composite score concerning Fertility preservation discussion (sperm banking / oocyte cryo) for childbearing-age
on_treatment	Day 1 of every 21-day cycle	TEST-CBC, TEST-CMP, TEST-LFT	ANC ≥1500 + platelets ≥100K before each cycle (delay or G-CSF if not) Neuropathy grade documented (CTCAE) — vincristine modification if ≥2 LVEF re-check after cumulative doxorubicin ~300 mg/m²
interim_response_assessment	After cycles 2-4 (interim PET-CT)	TEST-PET-CT, TEST-LDH	Lugano response criteria + Deauville score If Deauville 4-5 with mass progression → consider salvage or trial
end_of_treatment	After cycle 6 (within 6-8 weeks)	TEST-PET-CT, TEST-CBC, TEST-CMP, TEST-LDH	Confirm CR vs PR vs SD vs PD by Lugano/Deauville Begin survivorship plan: cardiac surveillance schedule, vaccination catch-up, second-cancer screening
follow_up_short	Every 3 months × 2 years post-treatment	TEST-CBC, TEST-CMP, TEST-LFT, TEST-LDH	Surveillance for relapse (~40% relapse risk by 2 years overall) HBV reactivation monitoring continues for 12 months post anti-CD20
follow_up_long	Every 6 months years 3-5, then annually	TEST-CBC, TEST-LFT, TEST-ECHO	Late cardiomyopathy screening (LVEF) annually if cumulative dox >300 Annual second-malignancy screening (skin, breast, etc. age-appropriate)

Timeline

Treatment timeline — derived from regimen + monitoring schedule

Standard plan

Baseline

Within 2 weeks before start

Induction · Acalabrutinib + Rituximab (con

28-day cycles × Acalabrutinib continuous; rituximab × 2 years then off

Response assessment

After cycle 6 (VenO) or every 6 months on BTKi

Follow-up

Every 3-6 months after treatment / continuously on BTKi

Aggressive plan

Baseline

Within 2 weeks before cycle 1

Induction · Intensive 1L MCL: alternating

21-day cycles × 6 alternating (3 R-CHOP + 3 R-DHAP), then BEAM/CBV-conditioned autoSCT, then R maintenance every 2 mo × 3 years

Response assessment

After cycles 2-4 (interim PET-CT)

Follow-up

Every 3 months × 2 years post-treatment

MDT brief

Skills (required) — mandatory virtual specialists (1)

Гематолог / онкогематолог required
Лімфомний діагноз — провідна спеціальність для терапевтичного ведення.
Owns: OQ-LDH-CURRENT
skill: hematologistv0.1.0reviewed 2026-04-25STUBsign-offs: 0lead: TBD

Skills (recommended) — for consideration (3)

Клінічний фармацевт recommended
Хіміоімунотерапевтичний схема — drug-drug interactions, dose adjustments, premedication.
skill: clinical_pharmacistv0.1.0reviewed 2026-04-25STUBsign-offs: 0lead: TBD
Молекулярний генетик / молекулярний онколог recommended
Indication посилається на actionable геномний біомаркер — потрібна інтерпретація мутації / target / actionability.
skill: molecular_geneticistv0.1.0reviewed 2026-04-25STUBsign-offs: 0lead: TBD
Патолог (загальний) recommended
Підтвердження гістології лімфоми + оцінка ризику трансформації (DLBCL/Richter).
Owns: OQ-CD20-CONFIRMATION
skill: pathologistv0.1.0reviewed 2026-04-25STUBsign-offs: 0lead: TBD

Open questions (3, 1 blocking)

BLOCKING OQ-CD20-CONFIRMATION
Чи підтверджено CD20+ статус гістологією (IHC)? Без CD20+ rituximab/obinutuzumab не показані.
Anti-CD20 терапія — основа для більшості ліній; відсутність експресії CD20 повністю змінює regimen.
→ pathologist
OQ-STAGING-COMPLETE
Чи виконано повне стадіювання (Lugano + PET/CT або CT)?
Прогноз і вибір треку залежать від stage та tumor burden.
→ radiologist
OQ-LDH-CURRENT
Який актуальний LDH? Маркер пухлинного навантаження і трансформації.
LDH входить у прогностичні індекси індолентних лімфом.
→ hematologist

Data quality

Missing critical: cd20_ihc_status, lugano_stage
Missing recommended: ldh_ratio_to_uln, fib4_index, pet_ct_date
Unevaluated RedFlags: RF-MCL-BLASTOID-OR-TP53, RF-MCL-BLASTOID-VARIANT, RF-MCL-FRAILTY-AGE, RF-MCL-INFECTION-SCREENING, RF-MCL-ORGAN-DYSFUNCTION, RF-MCL-TRANSFORMATION-PROGRESSION, RF-MIPI-HIGH, RF-MIPI-LOW

Skill catalog (4/16 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
Specialist з клітинної терапії (CAR-T)	`cellular_therapy_specialist`	v0.1.0	2026-04-25	cellular_therapy
Клінічний фармацевт	`clinical_pharmacist`	v0.1.0	2026-04-25	clinical_pharmacy
Гематолог / онкогематолог	`hematologist`	v0.1.0	2026-04-25	hematology_oncology
Гематопатолог (специфічно для лімфом / лейкозів / мієломи)	`hematopathologist`	v0.1.0	2026-04-25	hematopathology
Інфекціоніст / гепатолог	`infectious_disease_hepatology`	v0.1.0	2026-04-25	infectious_diseases
Медичний онколог (хіміотерапевт солідних пухлин)	`medical_oncologist`	v0.1.0	2026-04-25	solid_oncology
Молекулярний генетик / молекулярний онколог	`molecular_geneticist`	v0.1.0	2026-04-25	molecular_oncology
Паліативна допомога	`palliative_care`	v0.1.0	2026-04-25	palliative_care
Патолог (загальний)	`pathologist`	v0.1.0	2026-04-25	pathology
Сімейний лікар / терапевт	`primary_care`	v0.1.0	2026-04-25	primary_care
Психолог / онкопсихолог	`psychologist`	v0.1.0	2026-04-25	psychosocial
Радіотерапевт (променева терапія)	`radiation_oncologist`	v0.1.0	2026-04-25	radiation_oncology
Лікар-радіолог	`radiologist`	v0.1.0	2026-04-25	diagnostic_imaging
Соціальний працівник / кейс-менеджер	`social_worker_case_manager`	v0.1.0	2026-04-25	psychosocial
Хірург-онколог	`surgical_oncologist`	v0.1.0	2026-04-25	surgical_oncology
Specialist з трансплантації (BMT)	`transplant_specialist`	v0.1.0	2026-04-25	cellular_therapy

Sources cited

SRC-ESMO-MCL-2024: ESMO Clinical Practice Guideline on Mantle Cell Lymphoma (2024)
SRC-NCCN-BCELL-2025: NCCN Clinical Practice Guidelines in Oncology: B-Cell Lymphomas (v.2.2025)

Експериментальні опції (клінічні дослідження)

Останнє оновлення: 2026-04-26 · ctgov.

Жодного активного трайла для цього сценарію в ctgov не знайдено.

Доступність опцій в Україні

Per-track UA registration · НСЗУ · cost · access pathway. Render-time metadata; engine selection не залежить від цих полів (CHARTER §8.3).

Опція	Реєстрація UA	НСЗУ	Cost orientation	Access pathway
Standard plan Acalabrutinib + Rituximab (continuous BTKi + R) (REG-ACALABRUTINIB-RITUXIMAB)	✓ зареєстровано	✓ покривається	₴-? — verify pathway	НСЗУ formulary
Aggressive plan Intensive 1L MCL: alternating R-CHOP / R-DHAP × 6 cycles + autoSCT consolidation + R maintenance (REG-MCL-INTENSIVE-RDHAP-AUTOSCT)	✓ зареєстровано	✓ покривається	₴-? — verify pathway	НСЗУ formulary

Інформація про ціни — orientation. Перевіряти у конкретній аптеці / foundation / трайл-сайті. Status updated: 2026-04-27.

plan_id: PLAN-AUTO-MCL-001-V1 | version: 1 | generated: 2026-04-27T10:14:01.608312+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.