Treatment plan — Hairy Cell Leukemia

OpenOnco · HCL · Relapsed BRAF-V600E+ (Vemurafenib + Rituximab)

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OpenOnco · Treatment Plan

Treatment plan — Hairy Cell Leukemia

PLAN-HCL-RELAPSED-002-V1 · v1 · 2026-06-11

Patient

HCL-RELAPSED-002 · Algorithm: ALGO-HCL-2L

DiagnosisHairy Cell Leukemia

MOH / ICD-10C91.4

ICD-O-39940/3

Clinical significance of mutations (ESCAT)

Tumor-board context — the engine does not use these tiers to rank tracks

✅ Covered biomarkers (matched in KB)

Biomarker	Variant	ESCAT	Evidence	Clinical significance	Drugs	Sources
BIO-BRAF-V600E	V600E	IB	Molecular evidence option SRC-CIVIC: Level A (Supports, Sensitivity/Response) SRC-CIVIC: Level B (Supports, Poor Outcome) Resistance or avoidance signal SRC-CIVIC: Level B ⚠ Resistance SRC-CIVIC: Level C ⚠ Resistance SRC-CIVIC: Level D ⚠ Resistance Trial or research option SRC-CIVIC: Level C (Supports, Sensitivity/Response) SRC-CIVIC: Level D (Supports, Sensitivity/Response)	BRAF V600E is the defining molecular lesion of classic hairy cell leukemia (~100% of cHCL; absent in HCL-variant). Vemurafenib monotherapy yields CR ~35% / ORR ~96% in relapsed/refractory cHCL (Tiacci et al. NEJM 2015). Vemurafenib + rituximab gives durable CR in ~87% (Tiacci et al. NEJM 2021). Dabrafenib + trametinib also active. Used as salvage after purine-analog failure or in cladribine-ineligible patients.	vemurafenib monotherapy (R/R cHCL) vemurafenib + rituximab (consolidation / R/R) dabrafenib + trametinib (alternative)	SRC-NCCN-BCELL-2025

⚠️ Not included in plan

Biomarker	Status
BIO-CD20-IHC	BIO definition in KB; no ESCAT BMA entry — verify with clinician
BIO-CD11c	Not in KB — ask clinician to verify
BIO-CD25	Not in KB — ask clinician to verify
BIO-CD103	Not in KB — ask clinician to verify

Primary current-line option

Standard plan

★ DEFAULT

Indication

IND-HCL-2L-VEMURAFENIB

Regimen

Vemurafenib + rituximab for relapsed/refractory BRAF-V600E HCL

Drugs + NSZU

Rituximab (DRUG-RITUXIMAB) 375 mg/m² · IV every 2 weeks × 8 doses (combination arm) · IV ⚠ NSZU — not for this indication

Hard contraindications

CI-HBV-NO-PROPHYLAXIS

Reason

Primary current-line option selected by ALGO-HCL-2L at step 4.

Pre-treatment investigations

Investigations before treatment start · critical / standard / desired · merged across tracks

ID	Name	Priority	Category	Where to order	Needed for
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-CD20-IHC	CD20 Immunohistochemistry	Critical	histology	CSD Lab ✓ (code TBC)	all tracks
TEST-CMP	Comprehensive Metabolic Panel	Critical	lab	—	all tracks
TEST-DERMATOSCOPY	Dermatoscopy	Critical	clinical_assessment	—	all tracks
TEST-HBV-SEROLOGY	Hepatitis B Serology Panel (HBsAg, anti-HBc total, anti-HBs)	Critical	lab	—	all tracks
TEST-LFT	Liver Function Tests (ALT, AST, bilirubin, ALP, GGT, albumin)	Critical	lab	—	all tracks

Red flags — PRO / CONTRA aggressive

PRO-AGGRESSIVE

Triggers that push toward the aggressive track

Age >75 + ECOG ≥2 OR significant comorbidity — pentostatin's weekly schedule allows finer toxicity titration than cladribine 5-7 day continuous infusion; preferred for fragile patients.RF-HCL-FRAILTY-AGE

CONTRA-AGGRESSIVE

Hard contraindications to escalation

—

What NOT to do

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

Standard plan (IND-HCL-2L-VEMURAFENIB)

Do not prescribe vemurafenib without BRAF-V600E confirmation — pattern of toxicity without benefit.
Do not ignore cutaneous toxicity (rash, photosensitivity, secondary skin cancers) — dermatology surveillance every 3-6 mo.
Do not forget QT-prolongation monitoring — ECG baseline + during therapy.
Do not use in HCL-variant (BRAF-WT) — alternative pathway needed.
Do not start without HBV screening when adding rituximab.

Monitoring schedule

Monitoring schedule by treatment phase

Standard plan · MON-RITUXIMAB-MONO

Phase	Window	Tests	Checkpoints
baseline	Within 2 weeks before first dose	TEST-CBC, TEST-LFT, TEST-LDH, TEST-CD20-IHC, TEST-HBV-SEROLOGY, TEST-HCV-ANTIBODY, TEST-FLOW-CYTOMETRY	Confirm CD20+ histology HBV status + entecavir prophylaxis if HBsAg+ or anti-HBc+
induction	Day 1 of each weekly induction × 4	TEST-CBC, TEST-LFT	Infusion reactions especially first dose
maintenance	Every 2 months × 2 years	TEST-CBC, TEST-LFT, TEST-LDH	HBV-DNA quarterly during therapy and 12 mo post Disease assessment clinically; imaging if concern
follow_up	Every 6 months × 5 years post-treatment	TEST-CBC, TEST-LFT, TEST-LDH	Surveillance for relapse + transformation

Timeline

Treatment timeline — derived from regimen + monitoring schedule

Standard plan

Baseline

Within 2 weeks before first dose

Induction · Vemurafenib + rituximab for relapsed/refractory BRAF-V600E HCL

28-day cycles × Vemurafenib 960 mg PO BID continuous + rituximab × 8 doses (Tiacci 2021)

Maintenance

Every 2 months × 2 years

Follow-up

Every 6 months × 5 years post-treatment

MDT brief

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-HCL-FRAILTY-AGE, RF-HCL-HIGH-RISK-BIOLOGY, RF-HCL-INFECTION-SCREENING, RF-HCL-ORGAN-DYSFUNCTION, RF-HCL-TRANSFORMATION-PROGRESSION

Technical MDT skill metadata (0/16 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	Sign-offs	Domain
Cellular therapy specialist (CAR-T)	`cellular_therapy_specialist`	v0.1.0	2026-04-25	0	cellular_therapy
Clinical pharmacist	`clinical_pharmacist`	v0.1.0	2026-04-25	0	clinical_pharmacy
Hematologist / oncohematologist	`hematologist`	v0.1.0	2026-04-25	0	hematology_oncology
Hematopathologist (lymphoma / leukemia / myeloma)	`hematopathologist`	v0.1.0	2026-04-25	0	hematopathology
Infectious disease / hepatology	`infectious_disease_hepatology`	v0.1.0	2026-04-25	0	infectious_diseases
Medical oncologist (solid-tumor chemotherapist)	`medical_oncologist`	v0.1.0	2026-04-25	0	solid_oncology
Molecular geneticist / molecular oncologist	`molecular_geneticist`	v0.1.0	2026-04-25	0	molecular_oncology
Palliative care	`palliative_care`	v0.1.0	2026-04-25	0	palliative_care
Pathologist (general)	`pathologist`	v0.1.0	2026-04-25	0	pathology
Primary care / family physician	`primary_care`	v0.1.0	2026-04-25	0	primary_care
Psycho-oncologist	`psychologist`	v0.1.0	2026-04-25	0	psychosocial
Radiation oncologist	`radiation_oncologist`	v0.1.0	2026-04-25	0	radiation_oncology
Radiologist	`radiologist`	v0.1.0	2026-04-25	0	diagnostic_imaging
Social worker / case manager	`social_worker_case_manager`	v0.1.0	2026-04-25	0	psychosocial
Surgical oncologist	`surgical_oncologist`	v0.1.0	2026-04-25	0	surgical_oncology
Transplant specialist (BMT)	`transplant_specialist`	v0.1.0	2026-04-25	0	cellular_therapy

Sources cited

SRC-MOZ-UA-LYMPH-2013: Уnoфікований кліnoчний протокол первинної, вторинної (спеціалізованої) медичної допомоги: Лімфоми (2013-10-30 (Наказ МОЗ України № 866))
SRC-NCCN-BCELL-2025: NCCN Clinical Practice Guidelines in Oncology: B-Cell Lymphomas (v.2.2025)

Experimental options (clinical trials)

Last synced: 2026-06-11 · 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).

Option	UA registration	NSZU	Cost orientation	Access pathway
Standard plan Vemurafenib + rituximab for relapsed/refractory BRAF-V600E HCL (REG-VEMURAFENIB-HCL-RELAPSED)	✓ registered	✓ covered	₴-? — verify pathway	NSZU formulary

Cost information is orientation. Verify with a specific pharmacy / foundation / trial site. Status updated: 2026-06-11.

plan_id: PLAN-HCL-RELAPSED-002-V1 | version: 1 | generated: 2026-06-11T11:52:06.087827+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.