OpenOnco · Treatment Plan

Treatment plan — B-Lymphoblastic Leukemia/Lymphoma

PLAN-VERIFIED-B-ALL-L2-B_ALL_2L_INOTUZUMAB-V1 · v1 · 2026-09-09

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: 2026-09-09.

NCT	Title	Phase	Status	Sponsor	UA	Signals
NCT07582432	A Clinical Trial to Evaluate Efficacy, Safety, and Pharmacokinetics of Gamunex in Participants With Chronic Lymphocytic Leukemia, Multiple Myeloma, or Non-Hodgkin Lymphoma	PHASE3	RECRUITING	Grifols Biologicals, LLC	—	Small N (<50) Single country
NCT06350994	Early Assessment of Cardiac Function After Treatment With CAR-T Cells	N/A	RECRUITING	Assistance Publique - Hôpitaux de Paris	—	Single country
NCT07564453	Full-course Immunotherapy Combined With Chemotherapy in Newly Diagnosed B-cell Acute Lymphoblastic Leukemia	PHASE2	RECRUITING	The First Affiliated Hospital of Soochow University	—	Single country
NCT05674175	Co-administration of CART22-65s and huCART19 for B-ALL	PHASE1 / PHASE2	RECRUITING	Stephan Grupp MD PhD	—	Single country
NCT04836507	Study of Efficacy and Safety of CRC01 in Adult Large B-cell Lymphoma and B-cell Acute Lymphoblastic Leukemia Patients	PHASE1 / PHASE2	RECRUITING	Curocell Inc.	—	Surrogate endpoint only Single country
NCT06151730	Evaluation of Hypertension Management and Cardiovascular Adverse Event Prevention in Patients With B-cell Malignancies Undergoing Treatment With Bruton Tyrosine Kinase Inhibitors, the HALT Study	N/A	RECRUITING	Mayo Clinic	—	Single country
NCT05869279	Allogeneic CARCIK-CD19 in Adults/Pediatric B-cell NHL or Chronic Lymphocytic Leukemia	PHASE1 / PHASE2	RECRUITING	Fondazione Matilde Tettamanti Menotti De Marchi Onlus	—	Small N (<50) Surrogate endpoint only Single country
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
NCT06542250	A Study to Evaluate Safety, PK, PD and Efficacy of AZD5492, a T Cell-engaging Antibody Targeting CD20 in Subjects With R/R B-Cell Malignancies.	PHASE1 / PHASE2	RECRUITING	AstraZeneca	—	—
NCT07509151	Surovatamig as Consolidation Therapy in Participants With Chronic Lymphocytic Leukaemia or Small Lymphocytic Lymphoma With Unmutated Immunoglobulin Heavy Chain Variable (IGHV)	PHASE3	RECRUITING	AstraZeneca	—	Surrogate endpoint only

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 · NCT07582432 A Clinical Trial to Evaluate Efficacy, Safety, and Pharmacokinetics of Gamunex in Participants With Chronic Lymphocytic Leukemia, Multiple Myeloma, or Non-Hodgkin Lymphoma No UA site listed — international referral required	— unknown	— unknown	self-pay: ₴0/course	Trial sponsor
Trial · NCT06350994 Early Assessment of Cardiac Function After Treatment With CAR-T Cells No UA site listed — international referral required	— unknown	— unknown	self-pay: ₴0/course	Trial sponsor
Trial · NCT07564453 Full-course Immunotherapy Combined With Chemotherapy in Newly Diagnosed B-cell Acute Lymphoblastic Leukemia No UA site listed — international referral required	— unknown	— unknown	self-pay: ₴0/course	Trial sponsor
Trial · NCT05674175 Co-administration of CART22-65s and huCART19 for B-ALL No UA site listed — international referral required	— unknown	— unknown	self-pay: ₴0/course	Trial sponsor
Trial · NCT04836507 Study of Efficacy and Safety of CRC01 in Adult Large B-cell Lymphoma and B-cell Acute Lymphoblastic Leukemia Patients No UA site listed — international referral required	— unknown	— unknown	self-pay: ₴0/course	Trial sponsor
Trial · NCT06151730 Evaluation of Hypertension Management and Cardiovascular Adverse Event Prevention in Patients With B-cell Malignancies Undergoing Treatment With Bruton Tyrosine Kinase Inhibitors, the HALT Study No UA site listed — international referral required	— unknown	— unknown	self-pay: ₴0/course	Trial sponsor
Trial · NCT05869279 Allogeneic CARCIK-CD19 in Adults/Pediatric B-cell NHL or Chronic Lymphocytic Leukemia 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 · NCT06542250 A Study to Evaluate Safety, PK, PD and Efficacy of AZD5492, a T Cell-engaging Antibody Targeting CD20 in Subjects With R/R B-Cell Malignancies. No UA site listed — international referral required	— unknown	— unknown	self-pay: ₴0/course	Trial sponsor
Trial · NCT07509151 Surovatamig as Consolidation Therapy in Participants With Chronic Lymphocytic Leukaemia or Small Lymphocytic Lymphoma With Unmutated Immunoglobulin Heavy Chain Variable (IGHV) 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-VERIFIED-B-ALL-L2-B_ALL_2L_INOTUZUMAB-V1 | version: 1 | generated: 2026-09-09T12:26:44.019921+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.