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Treatment plan — Chronic Lymphocytic Leukemia / Small Lymphocytic Lymphoma
PLAN-AUTO-CLL-001-V1 · v1 · 2026-07-26
Patient
AUTO-CLL-001 · Algorithm: ALGO-CLL-1L
DiagnosisChronic Lymphocytic Leukemia / Small Lymphocytic Lymphoma
MOH / ICD-10C91.1
ICD-O-39823/3

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
BIO-CD5-IHCBIO definition in KB; no ESCAT BMA entry — verify with clinician
BIO-CD23-IHCBIO definition in KB; no ESCAT BMA entry — verify with clinician
BIO-NOTCH1-MUTATIONBIO definition in KB; no ESCAT BMA entry — verify with clinician

Primary current-line option

Standard plan
★ DEFAULT
Indication
IND-CLL-1L-BTKI
Regimen
Acalabrutinib monotherapy (continuous, until progression or intolerance)
Drugs + NSZU
  • Acalabrutinib (DRUG-ACALABRUTINIB) 100 mg · PO twice daily continuous · PO ⚠ NSZU — not for this indication
Hard contraindications
CI-HBV-NO-PROPHYLAXIS
Reason
Primary current-line option selected by ALGO-CLL-1L at step 3.

Other current-line alternatives (3 tracks)

Same treatment line; review when biomarker, access, contraindication, or patient-context assumptions change.
Aggressive plan
Indication
IND-CLL-1L-VENO
Regimen
Venetoclax + Obinutuzumab (VenO), 12 months fixed-duration (CLL14 schedule)
Drugs + NSZU
  • Obinutuzumab (DRUG-OBINUTUZUMAB) 100 mg cycle 1 day 1; 900 mg day 2; 1000 mg days 8 + 15; then 1000 mg day 1 of cycles 2-6 · IV monthly (28-day cycles), 6 cycles total · IV ✓ NSZU covered
  • Venetoclax (DRUG-VENETOCLAX) 5-week ramp starting cycle 1 day 22: 20 → 50 → 100 → 200 → 400 mg PO daily, then 400 mg daily continuous through cycle 12 · PO daily, total 12 months from start of ramp · PO ✓ NSZU covered
  • Allopurinol (DRUG-ALLOPURINOL) 300 mg PO daily · Start 72h before venetoclax ramp; continue ≥1 week post highest dose · PO ⚠ NSZU — not for this indication
Supportive care
SUP-TLS-PROPHYLAXIS, SUP-PJP-PROPHYLAXIS
Hard contraindications
CI-HBV-NO-PROPHYLAXIS
Reason
Current-line alternative presented for HCP consideration
Standard plan
Indication
IND-CLL-1L-ZANUBRUTINIB
Regimen
Zanubrutinib monotherapy (continuous, ALPINE-style)
Drugs + NSZU
  • Zanubrutinib (DRUG-ZANUBRUTINIB) 160 mg PO twice daily OR 320 mg PO once daily · Continuous until progression or unacceptable toxicity · PO ⚠ NSZU — not for this indication
Reason
Current-line alternative presented for HCP consideration
Aggressive plan
Indication
IND-CLL-1L-AVO
Regimen
Acalabrutinib + Venetoclax + Obinutuzumab (AVO), fixed-duration 14 cycles (AMPLIFY)
Drugs + NSZU
  • Acalabrutinib (DRUG-ACALABRUTINIB) 100 mg PO BID · Continuous twice daily, cycles 1-14 (entire duration) · PO ⚠ NSZU — not for this indication
  • Venetoclax (DRUG-VENETOCLAX) 5-week ramp-up starting cycle 3 day 1: week 1 20 mg → week 2 50 mg → week 3 100 mg → week 4 200 mg → week 5 400 mg; then 400 mg QD maintenance through cycle 14 · PO daily, cycles 3-14 (ramp begins cycle 3 day 1) · PO ✓ NSZU covered
  • Obinutuzumab (DRUG-OBINUTUZUMAB) Cycle 2 day 1: 100 mg IV; cycle 2 day 2: 900 mg IV; cycle 2 days 8+15: 1000 mg IV; cycles 3-7 day 1: 1000 mg IV · IV monthly (28-day cycles), cycles 2-7 (6 cycles total) · IV ✓ NSZU covered
Supportive care
SUP-TLS-PROPHYLAXIS, SUP-PJP-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-CBCComplete Blood Count with DifferentialCriticallab—all tracks
TEST-CECT-CAPCECT chest/abdomen/pelvisCriticalimaging—all tracks
TEST-CMPComprehensive Metabolic PanelCriticallab—all tracks
TEST-FISH-PANELFISH (Fluorescence In Situ Hybridization)CriticalgenomicCSD Lab ✓ (code TBC)all tracks
TEST-HBV-SEROLOGYHepatitis B Serology Panel (HBsAg, anti-HBc total, anti-HBs)Criticallab—all tracks
TEST-HCV-ANTIBODYHCV AntibodyCriticallab—all tracks
TEST-HIV-SEROLOGYHIV Antibody/AntigenCriticallab—all tracks
TEST-LDHLactate DehydrogenaseCriticallab—all tracks
TEST-LFTLiver Function Tests (ALT, AST, bilirubin, ALP, GGT, albumin)Criticallab—all tracks
TEST-B2-MICROGLOBULINBeta-2 MicroglobulinStandardlab—all tracks
TEST-ECHOEchocardiographyStandardimaging—all tracks
TEST-IMMUNOGLOBULINSQuantitative ImmunoglobulinsStandardlab—all tracks
TEST-URIC-ACIDSerum Uric AcidStandardlab—aggressive
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
  • Fit performance status (ECOG 0-1): patient is fully active or restricted in physically strenuous activity but ambulatory and able to carry out light work. Eligible for full-dose chemotherapy and intensive regimens (CHOEP, BEACOPP-escalated, HD-MTX, ASCT consolidation, CAR-T).
    Pan-disease eligibility gate. ECOG 0-1 is the canonical entry criterion for intensified regimens across DLBCL (CHOEP-21 in age ≤60 with elevated LDH per German High-Grade NHL Study Group), Hodgkin (BEACOPP-escalated), Burkitt…
    RF-FITNESS-ECOG-FITSRC-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
Standard plan (IND-CLL-1L-BTKI)
  • Do not prescribe chemoimmuno (FCR / BR) in high-risk CLL — survival impact substantial.
  • Do not start ibrutinib instead of acalabrutinib without justification — ELEVATE-RR showed better safety of acalabrutinib.
  • Do not skip baseline ECG + cardiology evaluation in atrial fibrillation history or HTN.
  • Do not combine BTKi with warfarin without strict monitoring — bleeding risk.
  • Do not treat asymptomatic CLL without iwCLL indication — surveillance is the standard.
Aggressive plan (IND-CLL-1L-VENO)
  • Do NOT skip the venetoclax 5-week ramp-up — fatal TLS documented.
  • Do NOT prescribe with concomitant strong CYP3A4 inhibitor during ramp-up — fatal concentration increase.
  • Do NOT start without HBV screening + entecavir prophylaxis if HBsAg+ or anti-HBc+ (anti-CD20 reactivation).
  • Do NOT skip TLS prophylaxis (allopurinol + hydration) — especially with ALC >25K or bulky disease.
  • Do NOT do ramp-up on an outpatient with high-burden disease — hospitalization with q6-8h labs required.
  • Do NOT forget PJP prophylaxis on prolonged obinutuzumab therapy.
Standard plan (IND-CLL-1L-ZANUBRUTINIB)
  • Do not prescribe ibrutinib instead of zanubrutinib without justification — ALPINE / ELEVATE-RR showed better safety of 2nd-gen BTKis.
  • Do not skip baseline ECG + cardiology evaluation in atrial fibrillation history or HTN.
  • Do not combine with warfarin without strict monitoring — bleeding risk (although lower than ibrutinib).
  • Do not treat asymptomatic CLL without iwCLL indication — surveillance is the standard.
  • Do not prescribe chemoimmuno (FCR / BR) in TP53-mut or del(17p) — survival impact substantial; BTKi is mandatory.
  • Do not skip hold ≥3-7 days pre-major surgery — bleeding risk.
  • Do NOT confirm the plan without funding pathway — zanubrutinib is NOT NSZU-reimbursed; ibrutinib (reimbursed) is fallback.

Monitoring schedule

Monitoring schedule by treatment phase

Standard plan · MON-CLL-BTKI

PhaseWindowTestsCheckpoints
BaselineWithin 2 weeks before startTEST-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 monthsTEST-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 (venetoclax)Per CLL14 schedule during 12-month VenO courseTEST-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 assessmentAfter cycle 6 (VenO) or every 6 months on BTKiTEST-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-upEvery 3-6 months after treatment / continuously on BTKiTEST-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

Timeline

Treatment timeline — derived from regimen + monitoring schedule

Standard plan

Baseline
Within 2 weeks before start
Induction · Acalabrutinib monotherapy (continuous, until progression or intolerance)
28-day cycles × Continuous until progression or intolerance
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 start
Induction · Venetoclax + Obinutuzumab (VenO), 12 months fixed-duration (CLL14 schedule)
28-day cycles × 6 obinutuzumab + 12 months total venetoclax
Response assessment
After cycle 6 (VenO) or every 6 months on BTKi
Follow-up
Every 3-6 months after treatment / continuously on BTKi

Standard plan

Baseline
Within 2 weeks before start
Induction · Zanubrutinib monotherapy (continuous, ALPINE-style)
28-day cycles × Continuous
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 start
Induction · Acalabrutinib + Venetoclax + Obinutuzumab (AVO), fixed-duration 14 cycles (AMPLIFY)
28-day cycles × 14 (fixed-duration)
Response assessment
After cycle 6 (VenO) or every 6 months on BTKi
Follow-up
Every 3-6 months after treatment / continuously on BTKi

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 (3 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.
3molecular_geneticistSpecialist review Indication references an actionable genomic biomarker — mutation / target / actionability interpretation needed.

Skills (recommended) — for consideration (2)

  • Clinical pharmacist recommended
    Chemoimmunotherapy regimen — drug-drug interactions, dose adjustments, premedication.
  • Molecular geneticist / molecular oncologist recommended
    Indication references an actionable genomic biomarker — mutation / target / actionability interpretation needed.

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: 3/3 known (100%), 0 missing, 0 default-track gaps
  • Unevaluated RedFlags: RF-BINET-A, RF-BINET-B-C, RF-CLL-FRAILTY-AGE, RF-CLL-HIGH-RISK, RF-CLL-INFECTION-SCREENING, RF-CLL-ORGAN-DYSFUNCTION, RF-CLL-POST-BTKI-C481-ACTIONABLE, RF-CLL-TP53-DELETION-ACTIONABLE, RF-CLL-TRANSFORMATION-PROGRESSION, RF-CLL-VEN-RESISTANT-ACTIONABLE, RF-RAI-HIGH, RF-RAI-LOW, RF-RICHTER-TRANSFORMATION
Technical MDT skill metadata (2/16 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)

Last synced: 2026-07-26 · ctgov.

No active trials matched this scenario in ctgov.

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
Standard plan
Acalabrutinib monotherapy (continuous, until progression or intolerance) (REG-ACALABRUTINIB-CONTINUOUS)
✓ registered✓ covered₴-? — verify pathwayNSZU formulary
Aggressive plan
Venetoclax + Obinutuzumab (VenO), 12 months fixed-duration (CLL14 schedule) (REG-VENETOCLAX-OBINUTUZUMAB)
✓ registered✓ covered₴-? — verify pathwayNSZU formulary
Standard plan
Zanubrutinib monotherapy (continuous, ALPINE-style) (REG-ZANUBRUTINIB-CONTINUOUS)
✓ registered✓ covered₴-? — verify pathwayNSZU formulary
Aggressive plan
Acalabrutinib + Venetoclax + Obinutuzumab (AVO), fixed-duration 14 cycles (AMPLIFY) (REG-AVO-CLL-1L)
✓ registered✓ covered₴-? — verify pathwayNSZU formulary

Cost information is orientation. Verify with a specific pharmacy / foundation / trial site. Status updated: 2026-07-26.

plan_id: PLAN-AUTO-CLL-001-V1 | version: 1 | generated: 2026-07-26T09:28:48.373200+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.