OpenOnco · B-ALL · MRD-positive (Blinatumomab)
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OpenOnco · Treatment Plan
Treatment plan — B-Lymphoblastic Leukemia/Lymphoma
PLAN-B-ALL-BLINA-001-V1 · v1 · 2026-07-26
Patient
B-ALL-BLINA-001 · 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
BiomarkerVariantESCATEvidenceClinical significanceDrugsSources
No clinically actionable variants matched in this profile.

Primary current-line option

Aggressive plan
★ DEFAULT
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
Primary current-line option selected by ALGO-B-ALL-2L at step 3.

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-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
Current-line alternative presented for HCP consideration

Pre-treatment investigations

Investigations before treatment start · critical / standard / desired · merged across tracks
IDNamePriorityCategoryWhere to orderNeeded for
TEST-BCR-ABL-JAK2BCR-ABL + JAK2 + CALR + MPLCriticalgenomicCSD Lab ✓ (code TBC)all tracks
TEST-BM-ASPIRATEBone Marrow AspirateCriticalhistologyall tracks
TEST-BM-TREPHINEBone Marrow TrephineCriticalhistologyall tracks
TEST-CBCComplete Blood Count with DifferentialCriticallaball tracks
TEST-CMPComprehensive Metabolic PanelCriticallaball tracks
TEST-COAG-PANELCoagulation PanelCriticallaball tracks
TEST-FISH-PANELFISH (Fluorescence In Situ Hybridization)CriticalgenomicCSD Lab ✓ (code TBC)all tracks
TEST-FLOW-CYTOMETRYFlow CytometryCriticalhistologyCSD Lab ✓ (code TBC)all tracks
TEST-HBV-SEROLOGYHepatitis B Serology Panel (HBsAg, anti-HBc total, anti-HBs)Criticallaball tracks
TEST-HCV-ANTIBODYHCV AntibodyCriticallaball tracks
TEST-HIV-SEROLOGYHIV Antibody/AntigenCriticallaball tracks
TEST-KARYOTYPEKaryotypeCriticalgenomicCSD Lab ✓ (code TBC)all tracks
TEST-LDHLactate DehydrogenaseCriticallaball tracks
TEST-LFTLiver Function Tests (ALT, AST, bilirubin, ALP, GGT, albumin)Criticallaball tracks
TEST-PREGNANCYBeta-HCGCriticallabdesired (aggressive)
TEST-CSF-CYTOLOGY-FLOWCSF cytology + flow cytometryStandardpathologyCSD Lab ✓ (code TBC)all tracks
TEST-ECHOEchocardiographyStandardimagingall tracks
TEST-URIC-ACIDSerum Uric AcidStandardlaball tracks
TEST-NGS-LYMPHOID-PANELLymphoid NGS PanelDesiredgenomicCSD 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-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.
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.

Timeline

Treatment timeline — derived from regimen + monitoring schedule

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

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)

MDT brief

Discussion questions (1, 0 blocking)

MDT talk tree (2 steps)

#OwnerTopicAction
1hematologistStaging / disease burden What is the current LDH? Marker of tumor burden and transformation.
2clinical_pharmacistSpecialist 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-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).
Specialistskill_idVersionLast reviewedSign-offsDomain
Cellular therapy specialist (CAR-T)cellular_therapy_specialistv0.1.02026-04-250cellular_therapy
Clinical pharmacistclinical_pharmacistv0.1.02026-04-250clinical_pharmacy
Hematologist / oncohematologisthematologistv0.1.02026-04-250hematology_oncology
Hematopathologist (lymphoma / leukemia / myeloma)hematopathologistv0.1.02026-04-250hematopathology
Infectious disease / hepatologyinfectious_disease_hepatologyv0.1.02026-04-250infectious_diseases
Medical oncologist (solid-tumor chemotherapist)medical_oncologistv0.1.02026-04-250solid_oncology
Molecular geneticist / molecular oncologistmolecular_geneticistv0.1.02026-04-250molecular_oncology
Palliative carepalliative_carev0.1.02026-04-250palliative_care
Pathologist (general)pathologistv0.1.02026-04-250pathology
Primary care / family physicianprimary_carev0.1.02026-04-250primary_care
Psycho-oncologistpsychologistv0.1.02026-04-250psychosocial
Radiation oncologistradiation_oncologistv0.1.02026-04-250radiation_oncology
Radiologistradiologistv0.1.02026-04-250diagnostic_imaging
Social worker / case managersocial_worker_case_managerv0.1.02026-04-250psychosocial
Surgical oncologistsurgical_oncologistv0.1.02026-04-250surgical_oncology
Transplant specialist (BMT)transplant_specialistv0.1.02026-04-250cellular_therapy

Sources cited

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: 2026-07-26.
NCTTitlePhaseStatusSponsorUASignalsEligibility (excerpt)
NCT02727803Personalized NK Cell Therapy in CBTPHASE2RECRUITINGM.D. Anderson Cancer CenterSurrogate endpoint only Single country
NCT05281809Local Manufacture of CAR T-Cell Products for the Treatment of B-Cell Lymphoma and B-Acute Lymphoblastic LeukemiaPHASE2RECRUITINGJohn ListerSmall N (<50) Single country
NCT05029531Combined Immuno-chemotherapy for Patients With B-linear Acute Lymphoblastic Leukemia Diagnosed From 0 to 365 Days of Life (ALL-Baby-2021)PHASE3RECRUITINGFederal Research Institute of Pediatric Hematology, Oncology and ImmunologySingle country
NCT06886074Efficacy of Short-course Blinatumomab for MRD Erradication in B-ALLPHASE2RECRUITINGHospital Universitario Dr. Jose E. GonzalezSmall N (<50) Single country
NCT07532525Pomalidomide After CAR T-cell Therapy for the Treatment of Relapsed or Refractory CD19+ B-cell Leukemia or LymphomaPHASE1RECRUITINGUniversity of Michigan Rogel Cancer CenterPhase 1 only Small N (<50) Single country
NCT05210907Clinical Study of Hospital-manufactured CD19 CAR-T in Children and Adolescents With Acute Lymphoblastic LeukemiaPHASE1RECRUITINGSeoul National University HospitalPhase 1 only Small N (<50) Single country
NCT07575919Targeted CD22/CD19 CAR-T Therapy for Consolidation in Standard-Risk B-ALLPHASE1 / PHASE2RECRUITINGLiping DouSmall N (<50) Single country
NCT03676504Treatment of Patients With Relapsed or Refractory CD19+ Lymphoid Disease With T Cells Expressing a Third-generation CARPHASE1 / PHASE2RECRUITINGUniversity Hospital HeidelbergSingle country
NCT07564453Full-course Immunotherapy Combined With Chemotherapy in Newly Diagnosed B-cell Acute Lymphoblastic LeukemiaPHASE2RECRUITINGThe First Affiliated Hospital of Soochow UniversitySingle country
NCT06528301A Phase 1 Study of UB-VV111 With and Without Rapamycin in Relapsed/Refractory CD19+ B-cell MalignanciesPHASE1RECRUITINGUmoja BiopharmaPhase 1 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).
OptionUA registrationNSZUCost orientationAccess pathway
Aggressive plan
Blinatumomab BiTE for MRD+ post-induction OR R/R B-ALL (REG-BLINATUMOMAB-B-ALL)
✓ registered✓ covered₴-? — verify pathwayNSZU formulary
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 pathwaynot recorded
Trial · NCT02727803
Personalized NK Cell Therapy in CBT
No UA site listed — international referral required
— unknown— unknown
self-pay: ₴0/course
Trial sponsor
Trial · NCT05281809
Local Manufacture of CAR T-Cell Products for the Treatment of B-Cell Lymphoma and B-Acute Lymphoblastic Leukemia
No UA site listed — international referral required
— unknown— unknown
self-pay: ₴0/course
Trial sponsor
Trial · NCT05029531
Combined Immuno-chemotherapy for Patients With B-linear Acute Lymphoblastic Leukemia Diagnosed From 0 to 365 Days of Life (ALL-Baby-2021)
No UA site listed — international referral required
— unknown— unknown
self-pay: ₴0/course
Trial sponsor
Trial · NCT06886074
Efficacy of Short-course Blinatumomab for MRD Erradication in B-ALL
No UA site listed — international referral required
— unknown— unknown
self-pay: ₴0/course
Trial sponsor
Trial · NCT07532525
Pomalidomide After CAR T-cell Therapy for the Treatment of Relapsed or Refractory CD19+ B-cell Leukemia or Lymphoma
No UA site listed — international referral required
— unknown— unknown
self-pay: ₴0/course
Trial sponsor
Trial · NCT05210907
Clinical Study of Hospital-manufactured CD19 CAR-T in Children and Adolescents With Acute Lymphoblastic Leukemia
No UA site listed — international referral required
— unknown— unknown
self-pay: ₴0/course
Trial sponsor
Trial · NCT07575919
Targeted CD22/CD19 CAR-T Therapy for Consolidation in Standard-Risk B-ALL
No UA site listed — international referral required
— unknown— unknown
self-pay: ₴0/course
Trial sponsor
Trial · NCT03676504
Treatment of Patients With Relapsed or Refractory CD19+ Lymphoid Disease With T Cells Expressing a Third-generation CAR
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 · NCT06528301
A Phase 1 Study of UB-VV111 With and Without Rapamycin in Relapsed/Refractory CD19+ B-cell Malignancies
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: 2026-07-26.