OpenOnco · B-ALL · T315I-mutated post-TKI (Ponatinib + alloHCT)
← Back to galleryFeedback on this case
OpenOnco · Treatment Plan
Treatment plan — B-Lymphoblastic Leukemia/Lymphoma
PLAN-B-ALL-T315I-001-V1 · v1 · 2026-06-11
Patient
B-ALL-T315I-001 · Algorithm: ALGO-B-ALL-2L
DiagnosisB-Lymphoblastic Leukemia/Lymphoma
MOH / ICD-10C91.0
ICD-O-39836/3

Clinical significance of mutations (ESCAT)

Tumor-board context — the engine does not use these tiers to rank tracks
✅ Covered biomarkers (matched in KB)
BiomarkerVariantESCATEvidenceClinical significanceDrugsSources
No clinically actionable variants matched in this profile.
⚠️ Not included in plan
BiomarkerStatus
BCR-ABL1Not in KB — ask clinician to verify

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.RF-B-ALL-FRAILTY-AGE
  • Philadelphia-positive B-ALL (BCR-ABL1+) — TKI (imatinib/dasatinib/ponatinib) + chemotherapy is standard; Ph-like B-ALL signature requires JAK/ABL pathway-targeted addition.RF-B-ALL-HIGH-RISK-BIOLOGY
  • Cardiac dysfunction (LVEF <50%) — anthracycline-based induction (hyper-CVAD A, BFM-style protocols) requires modification or substitution.RF-B-ALL-ORGAN-DYSFUNCTION
  • MRD-positive at end-of-induction (≥0.01% by flow or PCR) — switch to MRD-eradication strategy (blinatumomab, inotuzumab, or alloSCT consolidation).RF-B-ALL-TRANSFORMATION-PROGRESSION

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
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: 2026-06-11.
NCTTitlePhaseStatusSponsorUASignalsEligibility (excerpt)
NCT06967610Phase II Study of Combined Pirtobrutinib, Venetoclax and Obinutuzumab (PVO) Time-limited Treatment for Patients With Recurrent Chronic Lymphocytic Leukemia/Small Lymphocytic Lymphoma (CLL/SLL).PHASE2RECRUITINGM.D. Anderson Cancer CenterSmall N (<50) Single country
NCT01087333Collection of Human Samples to Study Hairy Cell and Other Leukemias, and to Develop Recombinant Immunotoxins for Cancer TreatmentN/ARECRUITINGNational Cancer Institute (NCI)Single country
NCT07509151Surovatamig as Consolidation Therapy in Participants With Chronic Lymphocytic Leukaemia or Small Lymphocytic Lymphoma With Unmutated Immunoglobulin Heavy Chain Variable (IGHV)PHASE3RECRUITINGAstraZenecaSurrogate endpoint only
NCT05887167Feasibility and Safety of Collecting and Combining Autologous Hematopoietic Stem Cells With Chimeric Antigen Receptor (CAR) T-Cell Therapy in Subjects With Relapsed/Refractory Hematological MalignanciesPHASE1RECRUITINGJoshua Sasine, MD, PhDPhase 1 only Small N (<50) Single country
NCT07221500A Study of NX-5948 in Adults With CLL/SLL Previously Treated With a Bruton's Tyrosine Kinase Inhibitor and a B-cell Lymphoma-2 Inhibitor (DAYBreak CLL-201)PHASE2RECRUITINGNurix Therapeutics, Inc.Surrogate endpoint only
NCT06735495CD19 & CD22 Bispecific CAR T Cells in the Treatment of Relapsed/Refractory B Cell Hematologic TumorsPHASE1 / PHASE2RECRUITINGUnion Hospital, Tongji Medical College, Huazhong University of Science and TechnologySurrogate endpoint only Single country
NCT01371630Inotuzumab Ozogamicin and Combination Chemotherapy in Treating Patients With Acute Lymphoblastic LeukemiaPHASE1 / PHASE2RECRUITINGM.D. Anderson Cancer CenterSurrogate endpoint only Single country
NCT02727803Personalized NK Cell Therapy in CBTPHASE2RECRUITINGM.D. Anderson Cancer CenterSurrogate endpoint only Single country
NCT06876662A Study of (LY3527727) Pirtobrutinib in Participants With Previously Treated Chronic Lymphocytic Leukemia/Small Lymphocytic Lymphoma or Non-Hodgkin LymphomaPHASE4RECRUITINGEli Lilly and Company
NCT06777979CD19-CD22-Bispecific Chimeric Antigen Receptor (CAR) T Cell Therapy for Pediatric Patients With Acute Lymphoblastic LeukemiaPHASE1RECRUITINGSt. Jude Children's Research HospitalPhase 1 only 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).
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 · NCT06967610
Phase II Study of Combined Pirtobrutinib, Venetoclax and Obinutuzumab (PVO) Time-limited Treatment for Patients With Recurrent Chronic Lymphocytic Leukemia/Small Lymphocytic Lymphoma (CLL/SLL).
No UA site listed — international referral required
— unknown— unknown
self-pay: ₴0/course
Trial sponsor
Trial · NCT01087333
Collection of Human Samples to Study Hairy Cell and Other Leukemias, and to Develop Recombinant Immunotoxins for Cancer Treatment
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
Trial · NCT05887167
Feasibility and Safety of Collecting and Combining Autologous Hematopoietic Stem Cells With Chimeric Antigen Receptor (CAR) T-Cell Therapy in Subjects With Relapsed/Refractory Hematological Malignancies
No UA site listed — international referral required
— unknown— unknown
self-pay: ₴0/course
Trial sponsor
Trial · NCT07221500
A Study of NX-5948 in Adults With CLL/SLL Previously Treated With a Bruton's Tyrosine Kinase Inhibitor and a B-cell Lymphoma-2 Inhibitor (DAYBreak CLL-201)
No UA site listed — international referral required
— unknown— unknown
self-pay: ₴0/course
Trial sponsor
Trial · NCT06735495
CD19 & CD22 Bispecific CAR T Cells in the Treatment of Relapsed/Refractory B Cell Hematologic Tumors
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 · NCT02727803
Personalized NK Cell Therapy in CBT
No UA site listed — international referral required
— unknown— unknown
self-pay: ₴0/course
Trial sponsor
Trial · NCT06876662
A Study of (LY3527727) Pirtobrutinib in Participants With Previously Treated Chronic Lymphocytic Leukemia/Small Lymphocytic Lymphoma or Non-Hodgkin Lymphoma
No UA site listed — international referral required
— unknown— unknown
self-pay: ₴0/course
Trial sponsor
Trial · NCT06777979
CD19-CD22-Bispecific Chimeric Antigen Receptor (CAR) T Cell Therapy for Pediatric Patients With Acute Lymphoblastic Leukemia
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: 2026-06-11.