OpenOnco · Treatment Plan

Treatment plan — B-Lymphoblastic Leukemia/Lymphoma

PLAN-VERIFIED-B-ALL-L2-B_ALL_2L_INOTUZUMAB-V1 · v1 · 2026-07-15

Patient

VERIFIED-B-ALL-L2-B_ALL_2L_INOTUZUMAB · Algorithm: ALGO-B-ALL-2L

DiagnosisB-Lymphoblastic Leukemia/Lymphoma

MOH / ICD-10C91.0

ICD-O-39811/3

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-B-ALL-2L-INOTUZUMAB

Regimen

Inotuzumab ozogamicin for R/R Ph- B-ALL 2L+ (bridge to alloHCT)

Drugs + NSZU

Inotuzumab ozogamicin (DRUG-INOTUZUMAB-OZOGAMICIN) Cycle 1 induction: 0.8 mg/m² IV day 1, 0.5 mg/m² IV days 8 + 15 (total 1.8 mg/m²); Cycle 2-6 consolidation post-CR: 0.5 mg/m² IV days 1, 8, 15 (total 1.5 mg/m²) · Cycles every 21-28 days; max 6 cycles; bridge to alloHCT after 1-2 cycles for transplant-eligible (limit pre-HCT exposure to mitigate VOD risk) · IV ✗ Not registered in UA

Supportive care

SUP-TLS-PROPHYLAXIS, SUP-HBV-PROPHYLAXIS

Hard contraindications

CI-HBV-NO-PROPHYLAXIS

Reason

Primary current-line option selected by ALGO-B-ALL-2L at step 2; branch-driving red flag: RF-B-ALL-HIGH-RISK-BIOLOGY.

Other current-line alternatives (1 tracks)

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

Aggressive plan

Indication

IND-B-ALL-BLINATUMOMAB-MRD-OR-RR

Regimen

Blinatumomab BiTE for MRD+ post-induction OR R/R B-ALL

Drugs + NSZU

Blinatumomab (DRUG-BLINATUMOMAB) R/R B-ALL: cycle 1: 9 µg/day continuous IV d1-7, then 28 µg/day d8-28 of 42-day cycle. Cycles 2-5: 28 µg/day d1-28. Up to 9 cycles. MRD+ B-ALL: 28 µg/day continuous IV d1-28 of 42-day cycle, up to 4 cycles. · Continuous IV via ambulatory infusion pump; hospitalization recommended cycle 1 d1-9 + cycle 2 d1-2; outpatient pump-driven thereafter · IV ✓ NSZU covered
Dexamethasone (DRUG-DEXAMETHASONE) 20 mg IV before first dose of cycle 1 (CRS prophylaxis); 20 mg IV before dose escalation cycle 1 d8 · Pre-dose only; not continuous · IV ⚠ NSZU — not for this indication

Supportive care

SUP-TLS-PROPHYLAXIS, SUP-HBV-PROPHYLAXIS

Hard contraindications

CI-HBV-NO-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 2 → branch IND-B-ALL-2L-INOTUZUMAB

RF-B-ALL-HIGH-RISK-BIOLOGY ★ winner: Philadelphia-positive B-ALL (BCR-ABL1+) — TKI (imatinib/dasatinib/ponatinib) + chemotherapy is standard; Ph-like B-ALL signature requires JAK/ABL pathway-targeted addition. SRC-NCCN-BCELL-2025SRC-ESMO-DLBCL-2024

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-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-PREGNANCY	Beta-HCG	Critical	lab	—	desired (aggressive)
TEST-CSF-CYTOLOGY-FLOW	CSF cytology + flow cytometry	Standard	pathology	CSD Lab ✓ (code TBC)	all tracks
TEST-ECHO	Echocardiography	Standard	imaging	—	all tracks
TEST-URIC-ACID	Serum Uric Acid	Standard	lab	—	all tracks
TEST-NGS-LYMPHOID-PANEL	Lymphoid NGS Panel	Desired	genomic	CSD Lab ✓ (code TBC)	all tracks

Red flags — PRO / CONTRA aggressive

PRO-AGGRESSIVE

Triggers that push toward the aggressive track

Age ≥65 OR ECOG ≥3 with comorbidities — pediatric-inspired regimens (CALGB 10403, hyper-CVAD) inadequately tolerated; reduced-intensity protocol (mini-HCVD ± inotuzumab/blinatumomab) preferred.
Pediatric-inspired adolescent-young-adult protocols dominate in fit <40; >65 mortality from induction toxicity is high. Mini-HCVD + inotuzumab/blinatumomab achieves better tolerability with comparable CR rates.
RF-B-ALL-FRAILTY-AGESRC-NCCN-BCELL-2025SRC-ESMO-DLBCL-2024
Philadelphia-positive B-ALL (BCR-ABL1+) — TKI (imatinib/dasatinib/ponatinib) + chemotherapy is standard; Ph-like B-ALL signature requires JAK/ABL pathway-targeted addition.
Ph+ B-ALL is a fundamentally different disease — TKI addition reverses what was historically the worst-prognosis subgroup. NCCN/ESMO both place TKI testing in upfront workup mandate.
RF-B-ALL-HIGH-RISK-BIOLOGYSRC-NCCN-BCELL-2025SRC-ESMO-DLBCL-2024
Cardiac dysfunction (LVEF <50%) — anthracycline-based induction (hyper-CVAD A, BFM-style protocols) requires modification or substitution.
Anthracycline-free B-ALL induction (e.g., blinatumomab-based MRD-guided) is emerging but not yet 1L standard outside trials. Flag drives cardio-onc co-management and dose modification.
RF-B-ALL-ORGAN-DYSFUNCTIONSRC-NCCN-BCELL-2025SRC-ESMO-DLBCL-2024
MRD-positive at end-of-induction (≥0.01% by flow or PCR) — switch to MRD-eradication strategy (blinatumomab, inotuzumab, or alloSCT consolidation).
MRD post-induction is the single strongest prognostic factor in B-ALL. Drives 2L/consolidation strategy (blinatumomab → alloSCT for fit), not 1L induction choice. Flag surfaces as MDT priority.
RF-B-ALL-TRANSFORMATION-PROGRESSIONSRC-NCCN-BCELL-2025SRC-ESMO-DLBCL-2024

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
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

What NOT to do

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

Aggressive plan (IND-B-ALL-2L-INOTUZUMAB)

Do NOT use with confirmed history of severe VOD/SOS — absolute CI.
Do NOT exceed 2 cycles pre-HCT — VOD risk is cumulative (boxed warning).
Do NOT use dual-alkylator (Bu/Cy) conditioning post-inotuzumab — Bu/Flu is preferred.
Do NOT ignore baseline + per-cycle LFT (bilirubin, ALT, AST) — hepatotoxicity is a prelude to VOD.
Do NOT start without CD22 confirmation — CD22-negative blasts evade targeting.
Do NOT forget TLS prophylaxis (allopurinol + hydration) — particularly cycle 1.
Do NOT forget the alloHCT-pathway — single-agent inotuzumab is NOT curative.

Aggressive plan (IND-B-ALL-BLINATUMOMAB-MRD-OR-RR)

Do NOT start without CD19 confirmation — CD19-negative blasts evade targeting; ~30% relapse-loss CD19.
Do NOT start without cytoreduction with BM blasts >50% OR PB blasts >15K — TLS + CRS risk amplified.
Do NOT ignore CRS / neurotox surveillance — hospitalization is mandatory cycle 1 d1-9, cycle 2 d1-2.
Do NOT use without on-site tocilizumab (≥2 dose) — fatal CRS possible.
Do NOT continue with Grade ≥3 recurrent neurotoxicity OR seizures — permanent discontinuation.
Do NOT prescribe prophylactic systemic corticosteroids beyond dexamethasone premedication — suppresses T-cell engagement + reduces efficacy.
Do NOT forget the alloHCT-pathway for transplant-eligible — single-agent blinatumomab not curative for R/R.

Timeline

Treatment timeline — derived from regimen + monitoring schedule

Aggressive plan

Induction · Inotuzumab ozogamicin for R/R Ph- B-ALL 2L+ (bridge to alloHCT)

21-day cycles × Up to 6 cycles; transplant-eligible patients should bridge to alloHCT after 1-2 cycles to minimize VOD/SOS risk (boxed warning)

Aggressive plan

Induction · Blinatumomab BiTE for MRD+ post-induction OR R/R B-ALL

42-day cycles × MRD+: up to 4 cycles; R/R: up to 9 cycles; bridge to alloHCT for transplant-eligible after MRD-negativity / CR

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-B-ALL-CNS-LEUKEMIA, RF-B-ALL-EMERGENCY-TLS-LEUKOSTASIS, RF-B-ALL-FRAILTY-AGE, RF-B-ALL-HIGH-RISK-BIOLOGY, RF-B-ALL-INFECTION-SCREENING, RF-B-ALL-ORGAN-DYSFUNCTION, RF-B-ALL-TRANSFORMATION-PROGRESSION, RF-BALL-CD22-POS-INO-CANDIDATE, RF-ETV6-CONFIRMED-CARRIER

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-BLAST-GOKBUGET-2018: Blinatumomab for minimal residual disease in adults with B-cell precursor acute lymphoblastic leukemia (2018)
SRC-INOVATE-KANTARJIAN-2016: Inotuzumab Ozogamicin versus Standard Therapy for Acute Lymphoblastic Leukemia (2016)
SRC-NCCN-BCELL-2025: NCCN Clinical Practice Guidelines in Oncology: B-Cell Lymphomas (v.2.2025)

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: 2026-07-15.

NCT	Title	Phase	Status	Sponsor	UA	Signals
NCT04807881	Phase Ib Clinical Study of Keynatinib	PHASE1	RECRUITING	Medolution Ltd.	—	Phase 1 only Surrogate endpoint only Single country
NCT01371630	Inotuzumab Ozogamicin and Combination Chemotherapy in Treating Patients With Acute Lymphoblastic Leukemia	PHASE1 / PHASE2	RECRUITING	M.D. Anderson Cancer Center	—	Surrogate endpoint only Single country
NCT04169737	Acalabrutinib and Venetoclax With or Without Early Obinutuzumab for the Treatment of High Risk, Recurrent, or Refractory Chronic Lymphocytic Leukemia or Small Lymphocytic Lymphoma	PHASE2	RECRUITING	M.D. Anderson Cancer Center	—	Single country
NCT06635330	Safety and Efficacy of CAR T Cell Therapy in Patients with R/r B-ALL	PHASE1 / PHASE2	RECRUITING	Kara Yakhteh Tajhiz Azma Company	—	Small N (<50) Single country
NCT04494503	Study of APG2575 Single Agent and Combination Therapy in Patients With Relapsed/Refractory CLL/SLL	PHASE1 / PHASE2	RECRUITING	Ascentage Pharma Group Inc.	—	Surrogate endpoint only Single country
NCT06514768	JY231 (JY231) Injection for the Treatment of B-cell Acute Lymphoblastic Leukemia (B-ALL)	EARLY_PHASE1	RECRUITING	920th Hospital of Joint Logistics Support Force of People's Liberation Army of China	—	Small N (<50) Single country
NCT05535855	UCD19 CAR T Therapy in Adults With B-ALL and MRD Positivity in CR1	PHASE1	RECRUITING	University of Colorado, Denver	—	Phase 1 only Small N (<50) Single country
NCT03314974	Myeloablative Allo HSCT With Related or Unrelated Donor for Heme Disorders	PHASE2	RECRUITING	Masonic Cancer Center, University of Minnesota	—	Single country
NCT06863259	Study of Inotuzumab Ozogamicin, Venetoclax, and Dexamethasone for Relapsed B-cell ALL	PHASE1	RECRUITING	Children's Hospital Medical Center, Cincinnati	—	Phase 1 only Small N (<50) Single country
NCT05794880	MCW Alpha/Beta T-Cell and B-Cell Depletion With Targeted ATG Dosing	NA	RECRUITING	Medical College of Wisconsin	—	Small N (<50) 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 Inotuzumab ozogamicin for R/R Ph- B-ALL 2L+ (bridge to alloHCT) (REG-INOTUZUMAB-B-ALL) 1/1 component drug(s) not registered in Ukraine +1	✗ not registered	✗ out-of-pocket	₴-? — verify pathway	not recorded
Aggressive plan Blinatumomab BiTE for MRD+ post-induction OR R/R B-ALL (REG-BLINATUMOMAB-B-ALL)	✓ registered	✓ covered	₴-? — verify pathway	NSZU formulary
Trial · NCT04807881 Phase Ib Clinical Study of Keynatinib No UA site listed — international referral required	— unknown	— unknown	self-pay: ₴0/course	Trial sponsor
Trial · NCT01371630 Inotuzumab Ozogamicin and Combination Chemotherapy in Treating Patients With Acute Lymphoblastic Leukemia No UA site listed — international referral required	— unknown	— unknown	self-pay: ₴0/course	Trial sponsor
Trial · NCT04169737 Acalabrutinib and Venetoclax With or Without Early Obinutuzumab for the Treatment of High Risk, Recurrent, or Refractory Chronic Lymphocytic Leukemia or Small Lymphocytic Lymphoma No UA site listed — international referral required	— unknown	— unknown	self-pay: ₴0/course	Trial sponsor
Trial · NCT06635330 Safety and Efficacy of CAR T Cell Therapy in Patients with R/r B-ALL No UA site listed — international referral required	— unknown	— unknown	self-pay: ₴0/course	Trial sponsor
Trial · NCT04494503 Study of APG2575 Single Agent and Combination Therapy in Patients With Relapsed/Refractory CLL/SLL No UA site listed — international referral required	— unknown	— unknown	self-pay: ₴0/course	Trial sponsor
Trial · NCT06514768 JY231 (JY231) Injection for the Treatment of B-cell Acute Lymphoblastic Leukemia (B-ALL) No UA site listed — international referral required	— unknown	— unknown	self-pay: ₴0/course	Trial sponsor
Trial · NCT05535855 UCD19 CAR T Therapy in Adults With B-ALL and MRD Positivity in CR1 No UA site listed — international referral required	— unknown	— unknown	self-pay: ₴0/course	Trial sponsor
Trial · NCT03314974 Myeloablative Allo HSCT With Related or Unrelated Donor for Heme Disorders No UA site listed — international referral required	— unknown	— unknown	self-pay: ₴0/course	Trial sponsor
Trial · NCT06863259 Study of Inotuzumab Ozogamicin, Venetoclax, and Dexamethasone for Relapsed B-cell ALL No UA site listed — international referral required	— unknown	— unknown	self-pay: ₴0/course	Trial sponsor
Trial · NCT05794880 MCW Alpha/Beta T-Cell and B-Cell Depletion With Targeted ATG Dosing 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: 2026-07-15.

plan_id: PLAN-VERIFIED-B-ALL-L2-B_ALL_2L_INOTUZUMAB-V1 | version: 1 | generated: 2026-07-15T13:33:22.806450+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.