OpenOnco · Treatment Plan

Treatment plan — Hairy Cell Leukemia

PLAN-VAR-HCL-RELAPSED-V1 · v1 · 2026-05-13

Patient

VAR-HCL-RELAPSED · 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

Biomarker	Variant	ESCAT	Evidence	Clinical significance	Drugs	Sources
No clinically actionable variants matched in this profile.

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-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	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-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)

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: 2026-05-13.

NCT	Title	Phase	Status	Sponsor	UA	Signals
NCT01137825	Registry of Older Patients With Cancer	N/A	RECRUITING	UNC Lineberger Comprehensive Cancer Center	—	Single country
NCT06764524	Hairy Cell Leukemia: Harnessing the Full Power of Extracellular Vesicles to Improve Patient Care Management	N/A	RECRUITING	IRCCS Azienda Ospedaliero-Universitaria di Bologna	—	Single country
NCT01087333	Collection of Human Samples to Study Hairy Cell and Other Leukemias, and to Develop Recombinant Immunotoxins for Cancer Treatment	N/A	RECRUITING	National Cancer Institute (NCI)	—	Single country
NCT04815356	Phase I Study of Anti-CD22 Chimeric Receptor T Cells in Patients With Relapsed/Refractory Hairy Cell Leukemia and Variant	PHASE1	RECRUITING	National Cancer Institute (NCI)	—	Phase 1 only Small N (<50) Single country
NCT02131753	Therapy Optimisation for the Treatment of Hairy Cell Leukemia	PHASE2 / PHASE3	RECRUITING	University of Giessen	—	Single country
NCT06561360	A Study of Vemurafenib and Obinutuzumab Compared to Cladribine and Rituximab in People With Hairy Cell Leukemia (HCL)	PHASE2	RECRUITING	Memorial Sloan Kettering Cancer Center	—	Single country
NCT06965114	Testing the Combination of Anti-cancer Drugs, Tovorafenib Plus Rituximab, in Patients With Hairy Cell Leukemia	PHASE1 / PHASE2	RECRUITING	National Cancer Institute (NCI)	—	Single country
NCT01137643	Tissue, Blood, and Body Fluid Sample Collection From Patients With Hematologic Cancer	N/A	RECRUITING	UNC Lineberger Comprehensive Cancer Center	—	Surrogate endpoint only Single country
NCT05283720	A Study to Evaluate Adverse Events and Change in Disease Activity of Subcutaneous (SC) Epcoritamab in Combination With Oral and Intravenous Anti-Neoplastic Agents in Adult Participants With Non-Hodgkin Lymphoma	PHASE2	RECRUITING	Genmab	—	—
NCT05362773	A Study of MGD024 in Patients With Relapsed or Refractory Hematologic Malignancies	PHASE1	RECRUITING	MacroGenics	—	Phase 1 only 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).

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
Trial · NCT01137825 Registry of Older Patients With Cancer No UA site listed — international referral required	— unknown	— unknown	self-pay: ₴0/course	Trial sponsor
Trial · NCT06764524 Hairy Cell Leukemia: Harnessing the Full Power of Extracellular Vesicles to Improve Patient Care Management 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 · NCT04815356 Phase I Study of Anti-CD22 Chimeric Receptor T Cells in Patients With Relapsed/Refractory Hairy Cell Leukemia and Variant No UA site listed — international referral required	— unknown	— unknown	self-pay: ₴0/course	Trial sponsor
Trial · NCT02131753 Therapy Optimisation for the Treatment of Hairy Cell Leukemia No UA site listed — international referral required	— unknown	— unknown	self-pay: ₴0/course	Trial sponsor
Trial · NCT06561360 A Study of Vemurafenib and Obinutuzumab Compared to Cladribine and Rituximab in People With Hairy Cell Leukemia (HCL) No UA site listed — international referral required	— unknown	— unknown	self-pay: ₴0/course	Trial sponsor
Trial · NCT06965114 Testing the Combination of Anti-cancer Drugs, Tovorafenib Plus Rituximab, in Patients With Hairy Cell Leukemia No UA site listed — international referral required	— unknown	— unknown	self-pay: ₴0/course	Trial sponsor
Trial · NCT01137643 Tissue, Blood, and Body Fluid Sample Collection From Patients With Hematologic Cancer No UA site listed — international referral required	— unknown	— unknown	self-pay: ₴0/course	Trial sponsor
Trial · NCT05283720 A Study to Evaluate Adverse Events and Change in Disease Activity of Subcutaneous (SC) Epcoritamab in Combination With Oral and Intravenous Anti-Neoplastic Agents in Adult Participants With Non-Hodgkin Lymphoma No UA site listed — international referral required	— unknown	— unknown	self-pay: ₴0/course	Trial sponsor
Trial · NCT05362773 A Study of MGD024 in Patients With Relapsed or Refractory Hematologic 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: 2026-05-13.

plan_id: PLAN-VAR-HCL-RELAPSED-V1 | version: 1 | generated: 2026-05-13T10:01:52.081905+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.